Clinical trial · Interventional
Comparing Fresh Random Platelets and Autologous Cryopreserved Thrombosol Treated Autologous Platelets
Randomized Crossover Study Comparing Fresh Random Platelets and Autologous Cryopreserved Thrombosol Treated Autologous Platelets
NCT00074763CI-TRIAL-00007725terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated due to low recruitment.
Summary
Brief summary (as posted)
Objectives: * Determine the corrected count increment of autologous transfused platelets that had been stored by cryopreservation with ThromboSol. * Determine the ability of autologous platelets that had been stored by cryopreservation with ThromboSol to correct thrombocytopenia.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Platelet Transfusion | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Platelet Transfusion
- description
- ThromboSol-preserved autologous platelet transfusion or Standard platelet transfusion. All patients receive both platelets frozen with Thrombosol and fresh random platelets. The order in which patients receive these two types of platelets randomized in a crossover design. Patients randomly assigned to receive either the sequence FRP then Thrombosol or Thrombosol then FRP. The randomization will occur after second cycle of chemotherapy, since all patients will receive FRP with the first cycle.
- interventionNames
- Biological: Platelet Transfusion
Primary outcomes (1)
- measure
- Patient Platelet Counts (CCI) Post-transfusion
- timeFrame
- Baseline and 18-24 hour post-transfusion platelet counts
Secondary outcomes (1)
- measure
- Patient's Corrected Count Increment (CCI) of autologous transfused platelets stored by cryopreservation with ThromboSol
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1\) 1.- Patients in remission with ALL, CLL, AML, CML, MDS will be allowed to participate in this program if their platelet count is \>150K, and the hemoglobin level is at least 8.0g/dl. The patient will receive their autologous platelets cryopreserved in ThromboSol or the fresh random platelets (FRP) whenever the need for such transfusions is determined to be clinically indicated by their physician(s). Exclusion Criteria: 1\) Patients with detectable circulating malignant cells or ongoing marrow involvement by the tumor will not be eligible.
References
Publications (0)
Data not yet available
No reference posted for this study.