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

Phase 3
Not Enrolling
Leukemia, Lymphoma

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Trial Information

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

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.

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.

Type of Study:


Study Design:

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

Outcome Measure:

Patient Platelet Counts (CCI) Post-transfusion

Outcome Time Frame:

Baseline and 18-24 hour post-transfusion platelet counts

Safety Issue:


Principal Investigator

Benjamin Lichtiger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

July 2003

Completion Date:

January 2006

Related Keywords:

  • Leukemia
  • Lymphoma
  • Leukemia
  • Lymphoma
  • ALL
  • CLL
  • AML
  • CML
  • MDS
  • Remission
  • Hematologic Disorder
  • Transfusion
  • Thrombosol
  • Autologous Platelet Transfusion
  • Platelet Transfusion
  • Single donor platelet apheresis
  • Cryopreservation
  • Thrombocytopenia
  • Leukemia
  • Lymphoma



UT M.D. Anderson Cancer Center Houston, Texas  77030