Comparing Fresh Random Platelets and Autologous Cryopreserved Thrombosol Treated Autologous Platelets

This study has been completed.

First Received: December 19, 2003 Last Updated: January 8, 2007 History of Changes

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00074763

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	Intervention	Phase
Leukemia Lymphoma	Procedure: Platelet Transfusion	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Crossover Study Comparing Fresh Random Platelets and Autologous Cryopreserved Thrombosol Treated Autologous Platelets

Resource links provided by NLM:

MedlinePlus related topics: Blood Transfusion and Donation Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment:	54
Study Start Date:	November 2003
Estimated Study Completion Date:	January 2006

Detailed Description:

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:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00074763

Locations

United States, Texas
UT M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Benjamin Lichtiger, MD

U.T. M.D. Anderson Cancer Center

More Information

No publications provided

Study ID Numbers:	ID03-0088
Study First Received:	December 19, 2003
Last Updated:	January 8, 2007
ClinicalTrials.gov Identifier:	NCT00074763 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Leukemia
Lymphoma
Transfusion
Thrombosol

Study placed in the following topic categories:

Lymphatic Diseases
Leukemia
Immunoproliferative Disorders
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Lymphatic Diseases
Leukemia
Neoplasms
Immunoproliferative Disorders

Neoplasms by Histologic Type
Immune System Diseases
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on July 02, 2009