Comparing Fresh Random Platelets and Autologous Cryopreserved Thrombosol Treated Autologous Platelets

This study has been terminated.
(Terminated due to low recruitment.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00074763
First received: December 19, 2003
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

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.

Condition Intervention Phase
Leukemia
Lymphoma
Biological: Platelet Transfusion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Crossover Study Comparing Fresh Random Platelets and Autologous Cryopreserved Thrombosol Treated Autologous Platelets

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Patient Platelet Counts (CCI) Post-transfusion [ Time Frame: Baseline and 18-24 hour post-transfusion platelet counts ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: July 2003
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00074763     History of Changes
Other Study ID Numbers: ID03-0088
Study First Received: December 19, 2003
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Leukemia
Lymphoma
ALL
CLL
AML
CML
MDS
Remission
Hematologic Disorder
Transfusion
Thrombosol
Autologous Platelet Transfusion
Platelet Transfusion
Single donor platelet apheresis
Cryopreservation
Thrombocytopenia

Additional relevant MeSH terms:
Leukemia
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014