Study Stopped
Terminated due to low recruitment.
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
1 other identifier
interventional
4
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 leukemia
Started Jul 2003
Shorter than P25 for phase_3 leukemia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
December 19, 2003
CompletedFirst Posted
Study publicly available on registry
December 23, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedAugust 2, 2012
August 1, 2012
2.5 years
December 19, 2003
August 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Platelet Counts (CCI) Post-transfusion
Baseline and 18-24 hour post-transfusion platelet counts
Secondary Outcomes (1)
Patient's Corrected Count Increment (CCI) of autologous transfused platelets stored by cryopreservation with ThromboSol
Platelet counts prior to transfusion and 18-24 hour post-transfusion
Study Arms (1)
Platelet Transfusion
EXPERIMENTALThromboSol-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.
Interventions
All receive both platelets frozen with Thrombosol and fresh random platelets (FRP), order received is randomized, i.e. receive either FRP then Thrombosol or Thrombosol then FRP.
Eligibility Criteria
You may qualify if:
- \) 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).
You may not qualify if:
- \) Patients with detectable circulating malignant cells or ongoing marrow involvement by the tumor will not be eligible.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin Lichtiger, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2003
First Posted
December 23, 2003
Study Start
July 1, 2003
Primary Completion
January 1, 2006
Study Completion
January 1, 2006
Last Updated
August 2, 2012
Record last verified: 2012-08