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Platelet Transfusion Requirements in Hematopoietic Transplantation (PATH)

This study is currently recruiting participants.
Verified August 2017 by Ottawa Hospital Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02650791
First Posted: January 8, 2016
Last Update Posted: August 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
  Purpose
It is hypothesized that a strategy using prophylactic oral Tranexamic Acid (TXA) with therapeutic platelet transfusions is safe and effective compared to prophylactic platelet transfusions in patients undergoing an autologous hematopoietic stem cell transplantation (who are at risk for bleeding).

Condition Intervention Phase
Hematologic Neoplasms Drug: Tranexamic Acid Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Platelet Transfusion Requirements in Hematopoietic Transplantation(PATH Pilot)

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Enrolment, as measured by the number of patients screened per month at each site [ Time Frame: monthly, up to 23 months ]
  • Number of off-protocol platelet transfusions, with a target of < 10% off-protocol transfusions in each treatment arm [ Time Frame: monthly, up to 23 months ]
  • Total number of platelet transfusions/group, with a target of 25% reduction in the tranexamic acid arm [ Time Frame: monthly, up to 23 months ]
  • Adherence to tranexamic acid use, defined as excellent (greater than or equal to 90% use), acceptable (75-90% use), poor (< 75% use) [ Time Frame: monthly, up to 23 months ]

Secondary Outcome Measures:
  • WHO (World Health Organization) Bleeding events of Grade 2 or higher [ Time Frame: daily, up to one month ]
  • Time from randomization to bleeding of WHO bleeding events Grade 2 or higher [ Time Frame: daily, up to one month ]
  • Number of days with bleeding of WHO bleeding events Grade 2 or higher [ Time Frame: daily, up to one month ]
  • Bleeding Severity Measurement Scale for bleeding events Grade 2 or higher [ Time Frame: daily, up to one month ]
  • Number of platelet and/or red cell transfusions [ Time Frame: daily, up to one month ]
  • Time to platelet recovery [ Time Frame: daily, up to one month ]
  • Number of days with platelet count < 10 x 10^9/L [ Time Frame: daily, up to one month ]
  • LOS (Length of hospital stay) [ Time Frame: Length of stay will be measured as the number of days elapsed between hospital admission and hospital discharge dates up to 1 month ]
    LOS=discharge date - admission date

  • Adverse transfusion reactions [ Time Frame: daily, up to one month ]
    Number and type of reactions will be recorded.

  • Bearman Toxicity Score [ Time Frame: Day 30 ]
    Validated scoring system to assess toxicity during stem cell transplantation

  • Infections at Day 30 [ Time Frame: Day 30 ]
  • Quality of Life measurements, as determined by a battery of QoL instruments [ Time Frame: daily, up to one month ]

Estimated Enrollment: 100
Study Start Date: October 2016
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Prophylactic Platelet Transfusions
Patients allocated to the prophylactic platelet transfusion group will receive a platelet transfusion when the measured platelet count is less than 10 x 109/L.
Experimental: Prophylactic Tranexamic Acid
Patients allocated to the prophylactic Tranexamic Acid group will receive a standardized routine oral dose of Tranexamic Acid 1 gram three times daily. Tranexamic Acid will start when Platelet count is less than 50 x 109/L and continue until platelet engraftment. Patients in this group will not receive routine prophylactic platelet transfusions
Drug: Tranexamic Acid

Detailed Description:

In Canada, over 1,500 autologous hematopoietic stem cell transplantations (ASCT) are performed annually for hematologic malignancies. It is currently standard practice to provide a prophylactic transfusion of platelets to prevent bleeding when the daily measured platelet count is less than 10 x 109/L. A patient may require up to six adult platelet doses during the post-transplant period. However, the true benefit of prophylactic platelet transfusions in the ASCT setting is unclear and has been called into question by several recent studies.

Prophylactic platelet transfusions may not only be unnecessary, they may be detrimental to the patient. Among blood products, platelet transfusions are associated with the highest risk of both infectious and non-infectious complications: this would include bacterial infections and allergic /febrile reactions. Moreover, the potential overuse of platelet products places a significant burden on a scarce health care resource that is provided through volunteer donations.

An alternative strategy to prevent bleeding and reduce the need for platelet transfusions involves administering Tranexamic Acid, an oral antifibrinolytic agent to stabilize blood clots and reduce bleeding. Tranexamic Acid is safe and effective in many clinical scenarios, and may be a reasonable alternative for prophylactic platelet transfusions. In the setting of ASCT, Tranexamic Acid may reduce bleeding and further enhance a strategy of therapeutic platelet transfusions where platelets are administered only in the event of active bleeding symptoms.

The effect of prophylactic platelet transfusions and Tranexamic Acid on clinical, quality of life and economic outcomes in patients receiving ASCT is unknown. The primary aim of this research program is to perform a randomized controlled trial to determine whether a strategy of prophylactic Tranexamic Acid (with therapeutic platelet transfusions) is safe and effective compared to prophylactic platelet transfusions in patients undergoing ASCT. Before conducting a larger trial, the investigators first propose a pilot randomized controlled trial to determine the feasibility of such a study.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Patients are aged 18 years old or older and undergoing an autologous HSCT (hematopoietic stem cell transplantation) for any hematologic malignancy.

Exclusion Criteria:

  1. A previous WHO grade 3 or 4 bleeding event
  2. A WHO grade 2 bleeding event within the past year
  3. A previous thrombotic event
  4. Current or previous (within 2 weeks) urinary tract bleeding
  5. An inherited hemostatic or thrombotic disorder
  6. Coagulopathy defined as a prothrombin time or activated partial thromboplastin time >1.5 times the upper limit of normal or fibrinogen less than 2 g/L
  7. A requirement for therapeutic anticoagulant or antiplatelet drugs
  8. Previously documented history of refractoriness to platelet transfusion secondary to HLA (Human Leukocyte Antigen) antibodies
  9. Significant renal impairment (creatinine >1.5 times the upper limit of normal)
  10. Pregnant or breast-feeding
  11. Unwilling or unable to provide informed consent
  12. Participant has ever had a pulmonary embolism, deep vein thrombosis, cerebral thrombosis or has active angina
  13. Participant has known history of subarachnoid hemorrhage
  14. Participant has acquired disturbances to his/her colour vision
  15. Participant has known sensitivity or allergy to Tranexamic Acid or any of its ingredients
  16. The current use of oral contraceptive pill (Birth Control Pill), hormonal contraceptives or hormone replacement therapy .
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02650791


Contacts
Contact: Lesley Yeung, BSc 613-737-8899 ext 72998 lyeung@ohri.ca

Locations
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N4N2
Contact: Jason Tay, MD    403-944-1880    Jason.Tay@ahs.ca   
Principal Investigator: Jason Tay, MD         
Canada, Ontario
Hamilton Health Sciences - Juravinski Hospital and Cancer Centre Not yet recruiting
Hamilton, Ontario, Canada, L8V 1C3
Contact: Irwin Walker, MD    905 521-2100 ext 76384    walkeri@mcmaster.ca   
Principal Investigator: Irwin Walker, MD         
London Health Sciences Center Recruiting
London, Ontario, Canada, N6A5W9
Contact: Anargyros Xenocostas, MD    519-685-8500 ext 58631    Anargyros.Xenocostas@lhsc.on.ca   
Principal Investigator: Anargyros Xenocostas, MD         
Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Alan Tinmouth, MD    737-8899 ext 73914    atinmouth@ohri.ca   
Principal Investigator: Alan Tinmouth, MD MSc RCPSC         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Alan Tinmouth, MD MSc Ottawa Hospital Research Institute
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02650791     History of Changes
Other Study ID Numbers: 20150629-01H
First Submitted: January 6, 2016
First Posted: January 8, 2016
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants