Comparing Fresh Random Platelets and Autologous Cryopreserved Thrombosol Treated Autologous Platelets

August 1, 2012 updated by: M.D. Anderson Cancer Center

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

Objectives:

  • Determine the corrected count increment of autologous transfused platelets that had been stored by cryopreservation with ThromboSol.
  • Determine the ability of autologous platelets that had been stored by cryopreservation with ThromboSol to correct thrombocytopenia.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Platelets are an important component of blood. Transfusions with platelets help to control bleeding in thrombocytopenic patients. Using the standard blood banking procedures, platelets can only be stored for up to 5 days. This is to help decrease the risk of contamination with bacteria. Currently, it is not possible to use cryopreserved (frozen) platelets because the platelets are damaged during the freezing process. Therefore, long-term banking of platelets or autologous donation (storing your own platelets to be given back to you at a later time) has not been possible. ThromboSol is a new solution that was designed to allow platelets to be frozen without damaging them. The use of ThromboSol may allow for long-term banking of platelets and/or autologous donations.

During a period of cancer remission and when you have enough platelets in your blood, you will undergo an apheresis procedure to collect platelets. This procedure is similar to donating plasma to a blood bank. You will have up to 6 apheresis procedures (on different days) to collect up to 6 units of autologous platelets that can be transfused back to you. The platelets that are collected will be frozen with ThromboSol and stored so that they may be given back to you if your platelet count drops below a certain level. The frozen platelets can be stored for up to 18 months.

When your platelet count drops below a certain level, you will be scheduled to have a platelet transfusion as part of your standard care.

Before the transfusion you will have blood drawn (around 1-2 teaspoons) to check on the number of platelets in your blood. You will then be randomly assigned (as in the toss of a coin) to either receive the standard platelet transfusion or a ThromboSol-preserved autologous platelet transfusion. After the transfusion, you will have additional blood drawn (around 1-2 teaspoons) to check on the number of platelets in your blood. These procedures will be repeated each time you require a platelet transfusion. However, you will not be randomly assigned again. Each time you receive an additional platelet transfusion, you will be assigned the group different from the one before. The type of transfusions will be alternated. For instance, if you were randomly assigned to receive the frozen platelets for your first transfusion, you will receive the standard transfusion next, then back to the frozen for the third transfusion.

If you develop side effects to the ThromboSol-preserved autologous platelet transfusion or the number of platelets in your blood does not increase after an infusion with the preserved platelets, you will be taken off the study and given a standard platelet transfusion.

This is an investigational study. Up to 54 participants will take part in this study. All will be enrolled at UTMDACC.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1) 1.- Patients in remission with ALL, CLL, AML, CML, MDS will be allowed to participate in this program if their platelet count is >150K, and the hemoglobin level is at least 8.0g/dl. The patient will receive their autologous platelets cryopreserved in ThromboSol or the fresh random platelets (FRP) whenever the need for such transfusions is determined to be clinically indicated by their physician(s).

Exclusion Criteria:

1) Patients with detectable circulating malignant cells or ongoing marrow involvement by the tumor will not be eligible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Platelet Transfusion
ThromboSol-preserved autologous platelet transfusion or Standard platelet transfusion. All patients receive both platelets frozen with Thrombosol and fresh random platelets. The order in which patients receive these two types of platelets randomized in a crossover design. Patients randomly assigned to receive either the sequence FRP then Thrombosol or Thrombosol then FRP. The randomization will occur after second cycle of chemotherapy, since all patients will receive FRP with the first cycle.
Biological: Platelet Transfusion
All receive both platelets frozen with Thrombosol and fresh random platelets (FRP), order received is randomized, i.e. receive either FRP then Thrombosol or Thrombosol then FRP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient Platelet Counts (CCI) Post-transfusion
Time Frame: Baseline and 18-24 hour post-transfusion platelet counts
Baseline and 18-24 hour post-transfusion platelet counts

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient's Corrected Count Increment (CCI) of autologous transfused platelets stored by cryopreservation with ThromboSol
Time Frame: Platelet counts prior to transfusion and 18-24 hour post-transfusion
Platelet counts prior to transfusion and 18-24 hour post-transfusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Benjamin Lichtiger, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

December 19, 2003

First Submitted That Met QC Criteria

December 22, 2003

First Posted (Estimate)

December 23, 2003

Study Record Updates

Last Update Posted (Estimate)

August 2, 2012

Last Update Submitted That Met QC Criteria

August 1, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID03-0088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lymphoma

Clinical Trials on Platelet Transfusion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe