Thrombocytopenia Clinical Trial
Official title:
PRESS Pathogen Reduction Extended Storage Study PRESS (Pathogen Reduction Extended Storage Study) A Pilot Study of Mirasol Platelets Treated in Platelet Additive Solution in Thrombocytopenic Patients
The PRESS trial is a single-center, two-part, randomized cross-over pilot study in Copenhagen that will evaluate 1) the safety and performance of Mirasol-treated and untreated platelet products stored for 2-4 days and for 7-days in Platelet Additive Solution (PAS) and 2) the correlation between the TEG® parameters and platelet count increments after platelet transfusions in thrombocytopenic subjects.
1. To evaluate in thrombocytopenic subjects the efficacy and safety of platelets treated
with Mirasol Pathogen Reduction Technology (PRT) in Platelet Additive Solution. The
following safety and efficacy measures will be compared between Mirasol treated and
untreated platelets stored for 2-4 days and stored for 7 days:
- Thrombelastography (TEG®) parameters: reaction time R, alpha angle α and maximal
amplitude (MA)
- Platelet Count Increment and Corrected Count Increment
- Time to next platelet transfusion
- Incidence of transfusion related (serious) adverse events
- Incidence and severity of bleedings
2. To evaluate the use of the TEG® parameters as a measure for platelet transfusion
efficacy and to evaluate the correlation between the TEG® parameters and the platelet
Corrected Count Increments after platelet transfusions in thrombocytopenic subjects.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04003220 -
Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker
|
||
| Completed |
NCT02948283 -
Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
| Recruiting |
NCT03633019 -
High-dose Use of rhTPO in CIT Patients
|
Phase 4 | |
| Recruiting |
NCT06087198 -
Clinical Performance Evaluation of T-TAS®01 HD Chip
|
||
| Recruiting |
NCT03605511 -
TTP and aHUS in Complicated Pregnancies
|
||
| Active, not recruiting |
NCT03688191 -
Study of Sirolimus in CTD-TP in China
|
Phase 4 | |
| Completed |
NCT02845609 -
Efficacy of Sialic Acid GNE Related Thrombocytopenia
|
Phase 2 | |
| Recruiting |
NCT02244658 -
Recombinant Human Thrombopoietin (rhTPO) in Management of Chemotherapy-induced Thrombocytopenia in Acute Myelocytic Leukemia
|
Phase 3 | |
| Recruiting |
NCT02241031 -
Megakaryocytic Progenitor Cells for Prophylaxis and Treatment of Thrombocytopenia
|
Phase 2/Phase 3 | |
| Completed |
NCT01356576 -
Effect of Hemodialysis Membranes on Platelet Count
|
N/A | |
| Unknown status |
NCT01196884 -
Immune Thrombocytopenia (ITP) Immune-Genetic Assessment
|
||
| Completed |
NCT00039858 -
Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin
|
Phase 4 | |
| Completed |
NCT00787241 -
Platelet Count Trends in Pre-eclamptic Parturients
|
N/A | |
| Completed |
NCT00001533 -
Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders With Cyclosporine
|
Phase 1 | |
| Not yet recruiting |
NCT06036966 -
The Efficacy and Safety of Hetrombopag in Primary Prevention of Thrombocytopenia Induced by the Niraparib Maintenance in Advanced Ovarian Cancer Patients
|
Phase 2 | |
| Completed |
NCT01791101 -
Eltrombopag in Patients With Delayed Post Transplant Thrombocytopenia.
|
Phase 2 | |
| Recruiting |
NCT06053021 -
Antiplatelet Therapy for AIS Patients With Thrombocytopenia
|
N/A | |
| Recruiting |
NCT03701217 -
Eltrombopag Used in Thrombocytopenia After Comsolidation Therapy in AML
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT05958511 -
Assessment of Risk Factors and Outcome of Thrombocytopenia in ICU Patients
|
||
| Completed |
NCT04917679 -
Eltrombopag Plus Diacerein vs Eltrombopag in Adult ITP
|
Phase 2 |