Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074763
Status:
TERMINATED
Last Update Posted:
2012-08-02
First Post:
2003-12-19
Brief Title:
Comparing Fresh Random Platelets and Autologous Cryopreserved Thrombosol Treated Autologous Platelets
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Randomized Crossover Study Comparing Fresh Random Platelets and Autologous Cryopreserved Thrombosol Treated Autologous Platelets
Status:
TERMINATED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to low recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 andor 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None