Reversal of Aspirin Antiplatelet Therapy With Cold Stored Platelets
NCT05111028 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2021-11-08
Summary
Purpose of this study is to compare the reversal responses of 4°C cold stored platelets (CSP) versus 7 day, 22°C room temperature stored platelets (RTP) when given to healthy adult subjects who have received a loading dose of aspirin antiplatelet therapy.
Conditions
- Reversal of Platelet Aggregation Inhibitors
Interventions
- BIOLOGICAL
-
Autologous Room Temperature stored Platelet transfusion
An autologous transfusion of platelets stored at 22°C for 7 days.
- BIOLOGICAL
-
Autologous Cold Stored Platelet transfusion
An autologous transfusion of platelets stored at 4°C for 7, 14, 21, or 28 days.
Sponsors & Collaborators
-
United States Department of Defense
collaborator FED -
Bloodworks
lead OTHER
Principal Investigators
-
Moritz Stolla, MD, PhD · Bloodworks
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 59 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-11-20
- Primary Completion
- 2021-11-30
- Completion
- 2021-11-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Study for Validation of In-vitro Turbidometric Platelet Aggregation Assay Using Human Blood in Healthy Volunteers
NCT02071628 ·Status: COMPLETED
-
National Multicenter Retrospective Real-World Study on the Treatment Status of Newly Diagnosed and Persistent Primary Immune Thrombocytopenia (ITP) Patients
NCT07268898 ·Status: NOT_YET_RECRUITING
-
Platelet Reactivity In Patients With Nuisance Bleeding On A Thienopyridine
NCT01152229 ·Status: COMPLETED
-
Efficacy of Immunomudulatory Therapy With All-trans Retinoid Acid for Adults With Chronic Immune Thrombocytopenia
NCT01668615 ·Status: COMPLETED
-
Clinical Management of Argatroban in Patients With Heparin Induced Thrombocytopenia Type II
NCT00861692 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Treatment Satisfaction in Adults With Chronic ITP After Switching to Avatrombopag From Eltrombopag or Romiplostim
NCT04638829 ·Status: COMPLETED ·Phase: PHASE4
-
The Association Between Platelet Reactivity and Bleeding Risk in Adult ITP
NCT03377439 ·Status: UNKNOWN
-
Blood Component Collection From Patients With Rheumatic or Kidney Disease and Healthy Volunteers
NCT00031174 ·Status: TERMINATED
-
This Clinical Study is to Test Efficacy and Safety of BT595 in Chronic Primary Immune Thrombocytopenia (ITP)
NCT02859909 ·Status: COMPLETED ·Phase: PHASE3
-
The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP)
NCT06291415 ·Status: WITHDRAWN ·Phase: PHASE1
-
Efficacy and Safety of Eltrombopag In Patients With Severe and Very Severe Aplastic Anemia
NCT01703169 ·Status: COMPLETED ·Phase: PHASE2
-
An Observational, Multicenter Study to Evaluate the Safety and Effectiveness of Hetrombopag in Patients With ITP or AA
NCT05333861 ·Status: NOT_YET_RECRUITING
-
Optimal Platelet Dose Strategy for Management of Thrombocytopenia
NCT00128713 ·Status: COMPLETED ·Phase: PHASE3
-
Diagnostic Role of Antiphospholipid Antibodies and Microparticles in Immune Thrombocytopenic Patients With Thrombosis
NCT05830916 ·Status: NOT_YET_RECRUITING
-
Study on the Safety and Efficacy of Cryopreserved Platelets in Hypoproliferative Thrombocytopenic Patients
NCT05067608 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study to Reveal if Fibrinogen Treatment Effects Blood Clotting Better Than a Platelet Transfusion
NCT01955811 ·Status: COMPLETED ·Phase: PHASE4
-
AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to Splenectomy
NCT00102323 ·Status: COMPLETED ·Phase: PHASE3
-
Anti-CD38 Antibody Treating APS With Thrombocytopenia
NCT05983952 ·Status: RECRUITING ·Phase: PHASE2
-
Protocol for the Infusion of Buffy Coat-derived Cryopreserved Platelets in Patients With Severe Thrombocytopenia
NCT02032134 ·Status: TERMINATED ·Phase: PHASE4
-
rhTPO in Critical Patients With Thrombocytopenia
NCT02094248 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
End of EXTEND: Discontinuation of Medication for Patients With Immune Thrombocytopenia
NCT01386723 ·Status: TERMINATED
-
Avatrombopag Combined With All-trans Retinoic Acid in the Treatment of Primary Immune Thrombocytopenia
NCT07278908 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2/PHASE3
-
ITP Registry and Accompanying Biospecimen Collection
NCT05152238 ·Status: RECRUITING
-
Efficacy and Safety Study of Platelets Treated for Pathogen Inactivation and Stored for Up to Seven Days
NCT00261924 ·Status: COMPLETED ·Phase: PHASE3
-
Basket Study to Assess Efficacy, Safety and PK of Iptacopan (LNP023) in Autoimmune Benign Hematological Disorders
NCT05086744 ·Status: TERMINATED ·Phase: PHASE2