Comparing Fresh Random Platelets and Autologous Cryopreserved Thrombosol Treated Autologous Platelets - Full Text View

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

MedlinePlus related topics:

Blood Transfusion and Donation Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma

U.S. FDA Resources

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

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

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