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Autologous Blood Transfusion |
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Clinical Trial: Comparing Fresh Random Platelets and Autologous Cryopreserved Thrombosol Treated Autologous Platelets
This study is currently recruiting patients.
Purpose
The objectives of this study are to determine the corrected count increment (CCI) of autologous transfused platelets that had been stored by cryopreservation with Thrombosol compared to fresh random platelets and to determine the safety of transfusing autologous platelets cryopreserved with Thrombosol.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Leukemia Lymphoma | Procedure: Platelet Transfusion | Phase III |
MedlinePlus related topics: Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood; Lymphoma
Study Type: Interventional
Study Design: Treatment, Randomized, Safety Study
Official Title: Randomized Crossover Study Comparing Fresh Random Platelets and Autologous Cryopreserved Thrombosol Treated Autologous Platelets
Expected Total Enrollment: 54
Study start: November 2003
The current method for cryopreservation of platelets is unsatisfactory due to the use of high concentration of cryoprotectants and poor numerical and functional recovery of platelets following the thawing of the cells. The use of Thrombosol for the cryopreservation of platelets yields high retention of in vitro and in vivo numerical and functional activity in conjunction with a directly transfusable formulation. This platelet preservation system will allow for the effective long-term storage of autologous platelets.
Eligibility
Genders Eligible for Study: Both
Accepts Healthy Volunteers
Criteria
Inclusion Criteria
- Patients in remission with Acute Lymphocytic Leukemia (ALL), Chronic Lymphocytic Leukemia (CLL), Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML), Myelodysplastic Syndrome (MDS) will be allowed to participate if their platelet count is > 150K and the hemoglobin level is at least 8.0 g/dl.
Exclusion Criteria
- Patients with detectable malignant cells or ongoing marrow involvement by the tumor will not be eligible.
Location and Contact Information
Texas
UT M.D. Anderson Cancer Center, Houston, Texas, 77030, United States; Recruiting
Carmen Luz Vargo 713-792-6313
Benjamin Lichtiger, M.D., Principal Investigator
More Information
Record last reviewed: July 2004
Last Updated: October 25, 2004
Record first received: December 19, 2003
ClinicalTrials.gov Identifier: NCT00074763
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Autologous Blood Transfusion (National Women's Health Information Center)
- Transfusion Alert: Use of Autologous Blood (National Heart, Lung, and Blood Institute Information Center, NHLBI, NIH, HHS)

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