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Suggestions within category "Transplant"


10 Study Matches

CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients

This is a Phase II/III, Single-center, Prospective, Open-label, Single Arm Study of 30 Simultaneous Kidney Pancreas recipients who received a transplant at least 3 months, but no more than 5 years prior, with a history of tremors following transplantation.
Jon Odorico, MD
All
18 Years to 70 Years old
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT03769298
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Inclusion Criteria:

• Adult, 18-70 years of age
• Participant must be able to understand and provide consent
• History of Diabetes Type 1 or Insulin-Dependent Diabetes Type 2 with Chronic Kidney Disease (CKD)
• Recipient of a Simultaneous Pancreas Kidney (SPK) transplant, 3- 60 months prior to screening, per Principal Investigator's discretion.
• Have a history of tremors following transplantation
• Stable pancreas allograft function as evidenced by no requirement of exogenous insulin or oral anti-diabetic agents and stable pancreatic enzymes
• Stable kidney allograft function
• Currently taking Immediate-Release (IR) tacrolimus
• Women of child-bearing potential (WOCP) must have a negative pregnancy test at the time of study entry
Exclusion Criteria:

• Currently maintained on an extended-release tacrolimus immunosuppressive regimen
• Previous history of tremors prior to transplantation
• Solitary pancreas transplant recipients
• History of solid organ transplant other than a kidney or pancreas
• Uncontrolled concomitant infection at the discretion of the investigator
• Presence of Donor Specific Antibodies
Kidney Pancreas Transplantation, Complications of kidney transplant, Transplant, Diabetes, Metabolism & Hormones
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A Dose-Escalation Study Evaluating Safety and Tolerability of Viral-Specific T Cells Against CMV in Adult Solid Organ Transplant Recipients

This study measures the tolerability of viral-specific T cells against Cytomegalovirus (CMV) in adult solid organ transplant (SOT) recipients. Participants are expected to be on study for 52 +/- 3 weeks.
Sandesh Parajuli, MD, MBBS
All
18 Years to 75 Years old
Phase 1
This study is NOT accepting healthy volunteers
NCT03950414
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Inclusion Criteria:
1. Adult (age ≥ 18 and ≤75) patients suffering from CMV reactivation/infections following solid organ transplantation (e.g., liver, pancreas, lung, heart, and multi-solid organ)
• CMV reactivation/viremia defined as positive (>250 copies/mL) CMV qPCR(quantitative polymerase chain reaction) AND/OR
• Presence of symptoms secondary to CMV infection or evidence of invasive CMV infection (e.g. pneumonitis, colitis) AND ONE OF THE FOLLOWING CRITERIA:
• Absence of an improvement of viral load after ≥ 14 days of standard antiviral therapy with ganciclovir, valganciclovir or foscarnet (decrease by at least 1 log, i.e. 10-fold), or
• New, persistent and/or worsening CMV-related symptoms, signs and/or markers of end organ compromise while on anti-viral therapy with medications such as ganciclovir, acyclovir, valganciclovir, foscarnet, cidofovir, IVIG(Intravenous immunoglobulin), and/or letermovir, or
• Have contraindications or experience adverse effects of anti-viral therapy with medications such as ganciclovir, acyclovir, valganciclovir, foscarnet, cidofovir, IVIG, and/or letermovir, or
• Known resistance to the anti-viral medications ganciclovir, foscarnet and/or cidofovir based on molecular testing 2. Availability of eligible donor 3. Written informed consent given by patient
Exclusion Criteria:
1. Patient with acute rejection of allograft at time of T-cell transfer 2. Patient receiving steroids (>0.5 mg/kg body weight (BW) prednisone equivalent) at the time of T-cell transfer 3. Patient treated with Thymoglobulin (ATG), Alemtuzumab or T-cell immunosuppressive monoclonal antibodies within 28 days 4. Patients with CMV retinitis 5. Concomitant enrollment in another clinical trial interfering with endpoints of this study 6. Any medical condition which could compromise participation in the study according to the investigator's assessment 7. Known HIV infection 8. Female patient who is pregnant or breast-feeding, or adult of reproductive potential not willing to use an effective method of birth control during study treatment Note: Women of childbearing potential must have a negative serum pregnancy test at study entry. 9. Patients unwilling or unable to comply with the protocol or unable to give informed consent Donor Eligibility Donor selection priority: The original donor will be the first choice as the source of T cells. If donation from the original organ donor is not possible (e.g., donor is unavailable or ineligible), then an alternative related donor will be selected, with preference for those who have full HLA matching in 6/6 loci over those with partial HLA matching (≥ 2/6 HLA loci). See Appendix 1 for patient and donor screening procedures. 1. ≥ 18 years old 2. Available and capable of undergoing a single standard 2 blood volume leukapheresis or donation of one unit of whole blood. 3. If the original transplant donor is not eligible, then an eligible fully matched or eligible partially matched family member will be used as the donor. 4. Related donors must be at least partially HLA compatible, matching with recipient in at least 2/6 HLA loci (HLA-A, HLA-B and HLA-DRB1 will be considered for this). 5. Donors must be CMV IgG seropositive. 6. Donors must show CMV T-cell activation after incubation with MACS GMP PepTivator Peptide Pools of CMV pp65 before undergoing leukapheresis. 7. Donor must meet the criteria for donor selection defined in the UWHC Hematopoietic Stem Cell Transplant Program SOP and FACT standards, which comply with 21 CFR 1271, subpart C. 8. Donor must provide written informed consent.
Cytomegaloviral disease, Kidney replaced by transplant, Cytomegalovirus Infections, Solid Organ Transplant
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Perioperative Vitamin C Lung Transplant

This study is being done to determine if parenterally administered ascorbic acid (Vitamin C) given at the time of lung transplant is safe. Vitamin C may be an effective intervention towards primary graft dysfunction (PGD). The study will enroll 69 participants who consent to the intervention. Participants who do not consent to the intervention will be treated according to standard-of-care, but may choose to be consented to have their data retrospectively reviewed. Based on our consent rate, this group may include 40-70 participants. Participants will be on study for up to 12 months.
Micah Long, MD
All
18 Years to 80 Years old
Phase 2
This study is also accepting healthy volunteers
NCT04505878
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Inclusion Criteria:

• Participant is scheduled for lung transplantation
Exclusion Criteria:

• Non-English speaking
• Subject is known or believed to be pregnant
• Subject is a prisoner.
• Subject has impaired decision-making capacity.
• Subject has known allergy to vitamin C.
• Subject has history of nephrolithiasis, oxalosis or hyperoxaluria. (Cystic Fibrosis patients are at risk of occult oxalosis / hyperoxaluria, therefore they will also be excluded from the study.)
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Sickle cell anemia
• Heredity hemochromatosis
• Baseline creatinine >2 mg/dL or any current kidney injury
• Weight <60 kg
• Vitamin C supplement use or administration (including HAT therapy) within the last month prior to transplantation
• Current enrolment in another research study
• Not suitable for study participation due to other reasons at the discretion of the investigators.
Primary Graft Dysfunction, Lung Transplant, Complications, Lung transplant rejection, Lung transplant infection, Transplant, Lung & Respiratory
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Treatment of GVHD in Hematopoietic Stem Cell Transplant (HSCT) Recipients Using AAT Plus Corticosteroids (CS) Compared With Corticosteroids Alone

Study CSL964_5001 will investigate the efficacy of AAT with corticosteroids compared with corticosteroids alone as first line therapy for patients with high-risk acute GVHD
Kalyan Nadiminti, MD
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04167514
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Inclusion Criteria:

• Patients 18 years of age or older
• Initial presentation of acute GVHD after allogeneic hematopoietic cell transplantation for any indication
• Any graft or donor source or conditioning intensity
• Clinical diagnosis of acute GVHD requiring systemic therapy with corticosteroids
Exclusion Criteria:

• Prior exogenous AAT exposure for GVHD prophylaxis
• Relapsed, progressing, or persistent malignancy
• de novo chronic GVHD or overlap syndrome developing before or present at the time of enrollment
• Receiving other drugs for the treatment of GVHD
• Receiving systemic CS for any indication within 7 days before the onset of acute GVHD
Hodgkin's Lymphoma, Leukemia, other, Lymphoid Leukemia, Multiple Myeloma, Mycosis Fungoides, Myeloid and Monocytic Leukemia, Non-Hodgkin's Lymphoma, Other Hematopoietic, Hematologic cancers, other, Leukemia, Lymphoma, Graft Versus Host Disease (GVHD)
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A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in participants with Type 1 diabetes mellitus (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.
Jon Odorico, MD
All
18 Years to 65 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04786262
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Key
Inclusion Criteria:

• Clinical history of T1D with > 5 years of duration
• At least two episodes of documented severe hypoglycemia in the 12 months prior to enrollment
• Stable diabetic treatment
• Consistent use of continuous glucose monitor (CGM) for at least 3 months before Screening and willingness to use CGM for the duration of the study Key
Exclusion Criteria:

• Prior islet cell transplant, organ transplant, or cell therapy Other protocol defined Inclusion/Exclusion criteria may apply
Diabetes Mellitus, Type 1, Impaired Hypoglycemic Awareness, Severe Hypoglycemia, Other specified diabetes mellitus, Transplant
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A Study to Compare T-Guard vs Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-vs-Host Disease (BMT CTN 2002) (2002)

This is an open-label, randomized, Phase 3, multicenter trial, which has been designed to compare the efficacy and safety of T-Guard to ruxolitinib in patients with Grade III or IV Steroid-Refractory acute Graft-Versus-Host Disease (SR-aGVHD). The primary hypothesis is that T-Guard treatment will improve the Day 28 complete response (CR) rate in patients with Grades III and IV SR-aGVHD compared to ruxolitinib.
Aric Hall, MD
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04934670
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Inclusion Criteria:
To be eligible to participate in this study, patients must meet the following: 1. Patients must be at least 18.0 years of age at the time of consent. 2. Patient has undergone first allo-HSCT from any donor source or graft source. Recipients of nonmyeloablative, reduced intensity, and myeloablative conditioning regimens are eligible. 3. Patients diagnosed with Grade III/IV SR-aGVHD after allo-HSCT. SR includes aGVHD initially treated at a lower steroid dose, but must meet one of the following criteria:
• Progressed or new organ involvement after 3 days of treatment with methylprednisolone (or equivalent) of greater than or equal to 2 mg/kg/day
• No improvement after 7 days of primary treatment with methylprednisolone (or equivalent) of greater than or equal to 2mg/kg/day
• Patients with visceral (GI and/or liver) plus skin aGVHD at methylprednisolone (or equivalent) initiation with improvement in skin GVHD without any improvement in visceral GVHD after 7 days of primary treatment with methylprednisolone (or equivalent) of greater than or equal to 2mg/kg/day
• Patients who have skin GVHD alone and develop visceral aGVHD during treatment with methylprednisolone (or equivalent) of greater than or equal to 1mg/kg/day and do not improve after 3 days of greater than or equal to 2mg/kg/day Improvement or progression in organs is determined by comparing current organ staging to staging at initiation of methylprednisolone (or equivalent) treatment. 4. Patients must have evidence of myeloid engraftment (e.g., absolute neutrophil count greater than or equal to 0.5 × 109/L for 3 consecutive days if ablative therapy was previously used). Use of growth factor supplementation is allowed. 5. Patients or an impartial witness (in case the patient is capable of providing verbal consent but not capable of signing the informed consent form (ICF)) should have given written informed consent.
Exclusion Criteria:
Patients will be excluded from study entry if they meet any of the following exclusion criteria: 1. Patients who have a creatinine greater than or equal to 2mg/dL or estimated creatinine clearance less than 40 mL/min or those requiring hemodialysis. 2. Patients who have been diagnosed with active TMA, defined as meeting all the following criteria:
• Greater than 4% schistocytes in blood (or equivalent if semiquantitative scale is used e.g., 3+ or 4+ schistocytes on peripheral blood smear)
• De novo, prolonged or progressive thrombocytopenia (platelet count less than 50 x 109/L or 50% or greater reduction from previous counts)
• Sudden and persistent increase in lactate dehydrogenase concentration greater than 2x ULN
• Decrease in hemoglobin concentration or increased transfusion requirement attributed to Coombs-negative hemolysis
• Decrease in serum haptoglobin 3. Patients who have previously received treatment with eculizumab. 4. Patients who have previously received checkpoint inhibitors (either before or after allo-HCT). 5. Patients who have been diagnosed with overlap syndrome, that is, with any concurrent features of cGVHD. 6. Patients requiring mechanical ventilation or vasopressor support. 7. Patients who have received any systemic treatment, besides steroids, as upfront treatment of aGVHD or as treatment for SR-aGVHD. Reinstitution of previously used GVHD prophylaxis agents (e.g., tacrolimus, cyclosporin, MTX, MMF) or substitutes in cases with previously documented intolerance will be permitted. Previous treatment with a JAK inhibitor as part of GVHD prophylaxis or treatment is not allowed. 8. Patients who have severe hypoalbuminemia, with an albumin of less than or equal to 1 g/dl. 9. Patients who have a creatine kinase (CK) level of greater than 5 times the upper limit of normal. 10. Patients with uncontrolled infections. Infections are considered controlled if appropriate therapy has been instituted and, at the time of enrollment, no signs of progression are present. Persisting fever without other signs or symptoms will not be interpreted as progressing infection. Progression of infection is defined as:
• hemodynamic instability attributable to sepsis OR
• new symptoms attributable to infection OR
• worsening physical signs attributable to infection OR
• worsening radiographic findings attributable to infection Patients with radiographic findings attributable to infection within 4 weeks prior to enrollment must have a repeat radiographic exam within one week of enrollment that documents absence of worsening. 11. Patients with evidence of relapsed, progressing, or persistent malignancy, or who have been treated for relapse after transplant, or who may require rapid immune suppression withdrawal as pre-emergent treatment of early malignancy relapse. 12. Patients with evidence of minimal residual disease requiring withdrawal of systemic immune suppression. 13. Patients with unresolved serious toxicity or complications (other than aGVHD) due to previous transplant. 14. History of sinusoidal obstruction syndrome (SOS)/veno-occlusive disease (VOD). 15. Patients with known hypersensitivity to any of the components murine mAb or Recombinant Ricin Toxin A-chain (RTA). 16. Patients who have had treatment with any other investigational agent, device, or procedure within 21 days (or 5 half-lives, whichever is greater) prior to enrollment. An investigational agent is defined as medications without any known FDA or EMA approved indications. 17. Patients who have received more than one allo-HSCT. 18. Patients with known human immunodeficiency virus infection. 19. Patients who have a BMI greater than or equal to 35 kg/m2. 20. Patients who are taking sirolimus must discontinue prior to starting study treatment. The sirolimus blood level must be less than 2 ng/mL prior to starting study treatment. 21. Female patients who are pregnant, breast feeding, or, if sexually active and of childbearing potential, unwilling to use effective birth control from start of treatment until 30 days after the last study treatment. 22. Male patients who are, if sexually active and with a female partner of childbearing potential, unwilling to use effective birth control from start of treatment until 65 days after the last study treatment. 23. Patients with any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the patient; or interfere with interpretation of study data. 24. Patients whose decision to participate might be unduly influenced by perceived expectation of gain or harm by participation, such as patients in detention due to official or legal order.
Steroid-Refractory Acute Graft Versus Host Disease, Other Hematopoietic, Hematologic cancers, other
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BK With VST for Kidney Transplant Patients

This study measures the safety, feasibility, and efficacy of viral-specific T cells (VST) against BK Virus (BKV) in adult kidney transplant recipients. Participants are expected to be on study for 52 weeks.
Sandesh Parajuli, MD, MBBS
All
18 Years to 75 Years old
Phase 1
This study is also accepting healthy volunteers
NCT05042076
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Inclusion Criteria:

• Adult (age ≥ 18 and ≤75) patients suffering from BKV infection/viremia following kidney transplantation
• BKV viremia defined as positive (≥ 250 copies/mL) BK qPCR AND
• Presence of evidence of invasive BKV infection (BK Nephropathy) AND ONE OF THE FOLLOWING CRITERIA:
• New, persistent and/or worsening BKV-related symptoms, signs and/or markers of end organ compromise despite being on lower immunosuppressive medication, OR
• Experiencing adverse effects of lower immunosuppressive medications (e.g., dnDSA, biopsy proven rejection)
• Original donor ≥ 18 years if available, BKV IgG positive, eligible and capable of undergoing a single standard 2 blood volume leukapheresis or donation of one unit of whole blood OR If original donor is not available, BKV IgG negative OR ineligible, then a BKV IgG positive fully or partially matched (at least 2/6 HLA-A, -B, -DRB1) family donor will be used
• Written informed consent given by patient
• Written informed consent given by donor
• Eligible Donor
Exclusion Criteria:

• Non-kidney organ transplant recipient
• Patient with acute rejection of the kidney allograft at time of T-cell transfer
• Patient receiving steroids (>0.5 mg/kg body weight (BW) prednisone equivalent) at the time of T-cell transfer
• Patient treated with Thymoglobulin (ATG), Alemtuzumab or T-cell immunosuppressive monoclonal antibodies within 28 days
• Patients with extra renal tissue invasive BKV infection ( biopsy proven)
• Concomitant enrollment in another clinical trial interfering with endpoints of this study
• Any medical condition which could compromise participation in the study according to the investigator's assessment
• Known HIV infection
• Female patient who is pregnant or breast-feeding, or adult of reproductive potential not willing to use an effective method of birth control during study treatment Note: Women of childbearing potential must have a negative urine pregnancy test at study entry.
• Patients unwilling or unable to comply with the protocol or unable to give informed consent Donor selection priority: The original donor will be the first choice as source of T cells. If the original donor is not available for donation of peripheral mononuclear cells or does not meet all donor eligibility criteria, alternative related donors will be selected, with preference for fully matched related donors over those with partial HLA matching (≥ 2/6 HLA loci).
• All donors must be ≥ 18 years old, available, BK IgG positive, eligible and capable of undergoing a single standard 2 blood volume leukapheresis. If original kidney transplant donor is not available, BK IgG negative or ineligible, a BK IgG positive fully or partially matched (≥ 2/6 HLA loci) family donor will be used.
• Related donors must be at least partially HLA compatible, matching with recipient in at least 2/6 HLA loci (HLA-A, HLA-B and HLA-DRB1 will be considered for this).
• Donors must be BK IgG seropositive.
• Donor must meet the criteria for donor selection defined in the Standard Operating Policies and Procedures (SOP B2.001) of the UWHC Hematopoietic Stem Cell Transplant Program.
Kidney Transplant Infection, BK Virus Infection, Kidney replaced by transplant, Infections, Immune System & Allergies, Kidney Disease & Urinary
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COVID Protection After Transplant-Immunosuppression Reduction (CPAT-ISR)

This study will enroll individuals who have: - Completed, at a minimum, a full 2-dose course but no more than 4 of either the Moderna messenger RNA (mRNA) based coronavirus infectious disease 19 (COVID-19) vaccine or the Pfizer-BioNTech mRNA based COVID-19 vaccine, and - An antibody response ≤ 250 U/mL measured at least 30 days after the last dose of vaccine. This group of patients is at high risk for severe COVID-19 disease due to pharmacologic immunosuppression and a high prevalence of non-transplant risk factors such as obesity and diabetes.
Jacqueline Garonzik Wang
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT05077254
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Inclusion Criteria:
Individuals who meet all the following criteria are eligible for enrollment as study participants- 1. Able to understand and provide informed consent 2. Recipient of a kidney or liver transplant ≥12 months prior to enrollment, without allograft rejection in the 6 months preceding enrollment 3. Negative for anti-donor human leukocyte antigens (HLA) antibodies at screening (Central Lab Test Determination). 4. Currently taking one of the following calcineurin inhibitors (CNI)-based immunosuppressive regimens:
• Tacrolimus plus Mycophenolate Mofetil (MMF) or Mycophenolic Acid (MPA), with or without a corticosteroid
• Tacrolimus with trough ≥ 5ng/mL with or without ≤5 mg of prednisone or equivalent 5. Received a minimum of 2 and no more than 4 doses of either the Moderna coronavirus infectious disease 19 (COVID-19) vaccine or Pfizer-BioNTech COVID-19 vaccine at least 30 days prior to study entry 6. Serum antibody negative or low (titer ≤ 250 U/mL) at ≥ 30 days from the last dose of mRNA COVID-19 vaccine, measured using the Roche Elecsys®) severe acute respiratory syndrome coronavirus type 2 serological (anti-SARS-CoV-2) S assay, and 7. Participant's transplant physician or midlevel practitioner who is clinically licensed to prescribe and manage immunosuppression must confirm the participant's eligibility based on medical history.
Exclusion Criteria:
Individuals who meet any of these criteria are not eligible for enrollment as study participants- 1. Currently on an immunosuppressive regimen different from the three regimens described in the Inclusion Criteria, for example (but not limited to) those including sirolimus, everolimus, belatacept, or azathioprine 2. Recipient of any allograft other than a kidney or liver 3. Participant is pregnant 4. Any past history of Donor Specific Antibody (DSA) using local site standards 5. Currently taking any systemic immunosuppressive agent, other than their prescribed transplant immunosuppression 6. Recipients of any COVID-19 vaccine other than the Moderna COVID-19 vaccine or the Pfizer-BioNTech COVID-19 vaccine 7. Known history of severe allergic reaction to any component of an authorized or licensed COVID-19 vaccine 8. Thrombotic events, myocarditis, or pericarditis temporally associated with a prior dose of COVID-19 vaccine 9. History of heparin-induced thrombocytopenia 10. Any change in transplant immunosuppression regimen (drug or dose) in response to suspected or proven rejection within the last 6 months 11. More than minimal graft dysfunction, in accordance with study definition 12. Receipt of any cellular depleting agent (e.g. antithymocyte globulins (ATG), rituximab, alemtuzumab, Cyclophosphamide) within 12 months preceding enrollment 13. Concurrent autoimmune disease at risk for exacerbation with immunosuppression reduction 14. Any untreated active infection including BK viremia >10^4 copies 15. Infection with human immunodeficiency virus (HIV) 16. Recent (within one year) or ongoing treatment for malignancy with the exception of:
• Non- melanomatous skin cancer definitively treated by local therapy, and
• Definitively treated carcinoma-in-situ of the cervix (Stage 0 cervical cancer) 17. Treatment or prophylaxis of COVID-19 with a monoclonal antibody product or convalescent plasma within 6 months preceding enrollment, or 18. Any past or current medical problems, treatments, or findings which, in the opinion of the investigator, may:
• pose additional risks from participation in the study,
• interfere with the candidate's ability to comply with study requirements, or
• impact the quality or interpretation of the data obtained from the study.
Other immunodeficiencies, Complications of transplanted organs and tissue, Transplant, Kidney Transplant Recipients, Liver Transplant Recipients
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CHIlled Platelet Study "CHIPS" (CHIPS)

A phase 3 randomized partial blind storage duration ranging study in patients undergoing complex cardiac surgery that will compare the transfusion of cold stored platelets to standard room temperature stored platelets. The primary objective is to establish that cold stored platelets have a non-inferiority (or superiority) to room temperature platelets.
Joseph Connor
All
29 Days to 84 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04834414
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Inclusion Criteria:

• Age greater than 28 days and less than 85 years
• Planned complex cardiac surgery with planned use of cardiopulmonary bypass
Exclusion Criteria:

• Expected order for washed or volume reduced platelets
• Patient with known anti-platelet antibodies
• Platelet transfusion refractoriness due to anti-HLA antibodies
• Known or suspected pregnancy
• Previously randomized in this study
• Conscious objection or unwillingness to receive blood products
• Known IgA deficiency
• Known congenital platelet disorder
• Known congenital bleeding disorder
• Planned post-operative extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), and/or continuous renal replacement therapy (CRRT)/ hemodialysis
• Patients intended to receive whole blood either intra-operative or post-operative for bleeding
• Platelet transfusion (of any type) within 24 hours prior to the date of surgery
• Pre-operative thrombocytopenia, defined as platelet count <75x10(9)/L, based on the most recent labs completed within 72 hours prior to the date of surgery.
Other acute ischemic heart diseases, Heart failure, Complications of heart transplant, Congenital malformation of heart, unspecified, Heart & Vascular, Acute Blood Loss
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Technology Enabled And Molecular Monitoring of the Allograft and Transplant rEcipient (TEAMMATE)

The primary objective of the study is to assess the impact of AlloCare mHealth remote monitoring on the early post-transplant period in solid organ transplantation.The outcome measure for primary objective is overall reduction in Readmission Rate to hospital in 90 days for all causes. Patients will be assessed across 4 different organ groups (Kidney, Liver, Lung and Heart Transplantation). The secondary objective is to consider the impact of mHealth and app-based monitoring on variables known to impact long term outcomes over the first 12 months post transplantation, as well as impact on quality of life. The outcome measures for secondary objective are: 1. Tacrolimus Variability (Time in Therapeutic Range,) as a surrogate to adherence and compliance 2. BPAR within 3,6, and 12 months 3. Patient satisfaction at 90 days 4. SF-36 change at 90 days 5. HbA1c monitoring (diabetic patients only)
Neetika Garg
All
12 Years and over
N/A
This study is also accepting healthy volunteers
NCT05033548
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Inclusion Criteria:

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 12 years or above. (Gillick Competent)
Exclusion Criteria:
The participant may not enter the trial if ANY of the following apply:
• Participant who is pregnant, lactating or planning pregnancy during the trial.
• Significant hepatic impairment (determined by the PI)
• Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
• Participant with life expectancy of less than 6 months, or inappropriate for diagnostic monitoring through regular blood sampling.
• >3 months post-transplant
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
• Participants who have participated in another research trial involving an investigational pharmaceutical product in the past 12 weeks.
• Multi-organ transplant (e.g., Kidney-Pancreas).
• Recipients of a transplant from a monozygotic (identical) twin
• Recipient of non-autologous bone marrow transplant
• Patients with a history of needle phobia.
• Patients who are not English or Spanish speaking
Transplant
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