Comparing Fresh Random Platelets and Autologous Cryopreserved Thrombosol Treated Autologous Platelets - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 19, 2003

Last Updated Date

January 8, 2007

Start Date ^†

November 2003

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00074763 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Comparing Fresh Random Platelets and Autologous Cryopreserved Thrombosol Treated Autologous Platelets

Official Title ^†

Randomized Crossover Study Comparing Fresh Random Platelets and Autologous Cryopreserved Thrombosol Treated Autologous Platelets

Brief Summary

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.

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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Efficacy Study

Condition ^†

Leukemia
Lymphoma

Intervention ^†

Procedure: Platelet Transfusion

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

January 2006

Primary Completion Date

Eligibility 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.

Gender

Both

Ages

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00074763

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

M.D. Anderson Cancer Center

Collaborators ^††

Investigators ^†

Principal Investigator:

Benjamin Lichtiger, MD

U.T. M.D. Anderson Cancer Center

Information Provided By

M.D. Anderson Cancer Center

Verification Date

January 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.