Comparing Fresh Random Platelets and Autologous Cryopreserved Thrombosol Treated Autologous Platelets

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00074763
• Other study ID #: ID03-0088
• Status: Terminated
• Phase: Phase 3
• First received: December 19, 2003
• Last updated: August 1, 2012
• Start date: July 2003
• Est. completion date: January 2006

Study information

• Verified date: August 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Lymphoma

Intervention

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.

Locations

Country	Name	City	State
United States	UT M.D. Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Platelet Counts (CCI) Post-transfusion		Baseline and 18-24 hour post-transfusion platelet counts	No
Secondary	Patient's Corrected Count Increment (CCI) of autologous transfused platelets stored by cryopreservation with ThromboSol		Platelet counts prior to transfusion and 18-24 hour post-transfusion	No

External Links

•   UT MD Anderson Cancer Center website