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Comparing Fresh Random Platelets and Autologous Cryopreserved Thrombosol Treated Autologous Platelets - Article


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Autologous Blood Transfusion




Clinical Trial: Comparing Fresh Random Platelets and Autologous Cryopreserved Thrombosol Treated Autologous Platelets

This study is currently recruiting patients.

Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center

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

Further Study Details: 

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

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
Benjamin Lichtiger, M.D.  713-792-6313 
Carmen Luz Vargo  713-792-6313 
Benjamin Lichtiger, M.D.,  Principal Investigator

More Information

Study ID Numbers:  ID03-0088
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

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December 4, 2008



Page Updated: November 5, 2004
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