Grant: Project Grant
Ottawa Hospital Research Institute
$1,507,050.00
Platelet Transfusions in Hematopoietic Stem Cell Transplantation - The PATH Phase III Trial
EF 2018-19
Résumé
Platelet transfusions have been part of routine supportive care for patients with hematologic malignancies since the 1960s. Current standard of practice is to transfuse platelets prophylactically to prevent bleeding when the platelet count is very low (less than 10 x 10^9/L). However, recent studies suggest that this practice may not reduce bleeding in patients undergoing autologous stem cell transplantion. We have successfully undertaken a pilot study to evaluate a trial comparing prophylactic tranexamic acid (a drug that reduces bleeding by preventing the break down of blood clots) to prophylactic platelet transfusions in
patients undergoing an autologous stem cell transplantation. We will now undertake a large study to determine if prophylactic tranexamic acid as compared to prophylactic platelet transfusions will reduce the amount of serious bleeding in patients undergoing an autologous stem cell transplant. A total of 662 patients will be enrolled at 9 Canadian transplant centres over the next 5 years. Patients will be randomly assigned to either prophylactic tranexamic acid or prophylactic platelet transfusions during the period immediately following the stem cell transplant. All patients can receive additional platelet transfusions to treat bleeding episodes. All patients will be followed daily for 6 months following their stem cell transplant. They will be monitored daily for bleeding daily using a standardized bleeding assessment until their platelet counts recover. They will also be followed for quality of life measureents (4 weeks) and any adverse events (6 months).
Programme
Project Grant
Bénéficiaire
Emplacement
Ontario, Canada
Type de bénéficiaire
Other
Type
Grant
Source
CIHR Funding Decisions Database
Tel que publié
Id
402362
Name
Tinmouth Alan T
Region
Ontario
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Circulatory and Respiratory Health
Theme2
Clinical
Prcname2
Randomized Controlled Trials
Projecttitle
Platelet Transfusions in Hematopoietic Stem Cell Transplantation - The PATH Phase III Trial
Programtype2
Operating Grants
Orgnameinp2
Ottawa Hospital Research Institute
Cihramount2
$1,507,050
Cihrequipment2
$0
Programname2
Project Grant
Keyworddelim
Autologous Stem Cell Transplant; Bleeding; Cost-Effectiveness Analysis; Patient Centred Outcomes; Platelet Transfusions; Randomized Controlled Trial; Tranexamic Acid
Abstract
Platelet transfusions have been part of routine supportive care for patients with hematologic malignancies since the 1960s. Current standard of practice is to transfuse platelets prophylactically to prevent bleeding when the platelet count is very low (less than 10 x 10^9/L). However, recent studies suggest that this practice may not reduce bleeding in patients undergoing autologous stem cell transplantion. We have successfully undertaken a pilot study to evaluate a trial comparing prophylactic tranexamic acid (a drug that reduces bleeding by preventing the break down of blood clots) to prophylactic platelet transfusions in
patients undergoing an autologous stem cell transplantation. We will now undertake a large study to determine if prophylactic tranexamic acid as compared to prophylactic platelet transfusions will reduce the amount of serious bleeding in patients undergoing an autologous stem cell transplant. A total of 662 patients will be enrolled at 9 Canadian transplant centres over the next 5 years. Patients will be randomly assigned to either prophylactic tranexamic acid or prophylactic platelet transfusions during the period immediately following the stem cell transplant. All patients can receive additional platelet transfusions to treat bleeding episodes. All patients will be followed daily for 6 months following their stem cell transplant. They will be monitored daily for bleeding daily using a standardized bleeding assessment until their platelet counts recover. They will also be followed for quality of life measureents (4 weeks) and any adverse events (6 months).
Competitiondate
201903
Approvedterm2
5 yrs 0 mth
Pinamesdelim
Tinmouth, Alan T; Maze, Dawn; Tay, Jason
Approvedterm
5 ans 0 mois
Cihrcontribution2
~ $1,507,050~ $0~