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Hematologic NeoplasmsPhase 3PATHNCT02650791

Platelet Transfusion Requirements in Hematopoietic Transplantation Pilot Study

A Phase 3 study testing Tranexamic Acid in people with Hematologic Neoplasms, run by Ottawa Hospital Research Institute at 5 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Hematologic Neoplasms
What is being tested?
Tranexamic Acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
5 sitesCanada
Study dates
Oct 2016to Dec 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • A previous WHO grade 3 or 4 bleeding event
  • A WHO grade 2 bleeding event within the past year
  • A previous or current unprovoked thrombotic event defined as a pulmonary embolism, deep vein thrombosis, cerebral thrombosis
  • Current or previous (within 2 weeks) urinary tract bleeding
  • An inherited hemostatic or thrombotic disorder
  • 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
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  • A requirement for therapeutic anticoagulant or antiplatelet drugs
  • Previously documented history of refractoriness to platelet transfusion secondary to HLA (Human Leukocyte Antigen) antibodies
  • Significant renal impairment (creatinine >1.5 times the upper limit of normal)
  • Pregnant or breast-feeding
  • Unwilling or unable to provide informed consent
  • Participant has ever had a pulmonary embolism, deep vein thrombosis, cerebral thrombosis or has active angina
  • Participant has known history of subarachnoid hemorrhage
  • Participant has acquired disturbances to his/her colour vision
  • Participant has known sensitivity or allergy to Tranexamic Acid or any of its ingredients
  • The current use of oral contraceptive pill (Birth Control Pill), hormonal contraceptives or hormone replacement therapy .

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N4N2

  • Hamilton Health Sciences - Juravinski Hospital and Cancer Centre

    Hamilton, Ontario, L8V 1C3

  • London Health Sciences Centre

    London, Ontario, N6A5W9

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: Platelet Transfusion Requirements in Hematopoietic Transplantation(PATH Pilot)

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).

Read the 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.

Being tested
Tranexamic Acid
Medical subject headings
Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02650791
Study groupRoleWhat they receive
Prophylactic Platelet TransfusionsNo interventionPatients allocated to the prophylactic platelet transfusion group will receive a platelet transfusion when the measured platelet count is less than 10 x 10^9/L.
Prophylactic Tranexamic AcidExperimentalPatients 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 10^9/L and continue until platelet engraftment. Patients in this group will not receive routine prophylactic platelet transfusions
Receives: Drug: Tranexamic Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Enrolment, as measured by the number of patients screened per month at each site

    Measured: monthly, up to 23 months

  2. Number of off-protocol platelet transfusions, with a target of < 10% off-protocol transfusions in each treatment arm

    Measured: monthly, up to 23 months

  3. Total number of platelet transfusions/group, with a target of 25% reduction in the tranexamic acid arm

    Measured: monthly, up to 23 months

  4. Adherence to tranexamic acid use, defined as excellent (greater than or equal to 90% use), acceptable (75-90% use), poor (< 75% use)

    Measured: monthly, up to 23 months

Secondary outcomes (12)

  1. WHO (World Health Organization) Bleeding events of Grade 2 or higher

    Measured: daily, up to one month

  2. Time from randomization to bleeding of WHO bleeding events Grade 2 or higher

    Measured: daily, up to one month

  3. Number of days with bleeding of WHO bleeding events Grade 2 or higher

    Measured: daily, up to one month

  4. Bleeding Severity Measurement Scale for bleeding events Grade 2 or higher

    Measured: daily, up to one month

  5. Number of platelet and/or red cell transfusions

    Measured: daily, up to one month

  6. Time to platelet recovery

    Measured: daily, up to one month

  7. Number of days with platelet count < 10 x 10^9/L

    Measured: daily, up to one month

  8. LOS (Length of hospital stay)

    LOS=discharge date - admission date

    Measured: Length of stay will be measured as the number of days elapsed between hospital admission and hospital discharge dates up to 1 month

  9. Adverse transfusion reactions

    Number and type of reactions will be recorded.

    Measured: daily, up to one month

  10. Bearman Toxicity Score

    Validated scoring system to assess toxicity during stem cell transplantation

    Measured: Day 30

  11. Infections at Day 30

    Measured: Day 30

  12. Quality of Life measurements, as determined by a battery of QoL instruments

    Measured: daily, up to one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionJun 2019
  4. Study completionDec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02650791
Sponsor's protocol ID
20150629-01H
Acronym
PATH
Status last verified
May 2020
First submitted
6 Jan 2016
Last updated
18 May 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Tay J, Allan D, Beattie S, Bredeson C, Fergusson D, Maze D, Sabloff M, Thavorn K, Tinmouth A. Rationale and design of platelet transfusions in haematopoietic stem cell transplantation: the PATH pilot study. BMJ Open. 2016 Oct 24;6(10):e013483. doi: 10.1136/bmjopen-2016-013483.

    PubMed 27798034

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tranexamic Acid in people with Hematologic Neoplasms, run by Ottawa Hospital Research Institute at 5 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Enrolment, as measured by the number of patients screened per month at each site (time frame: monthly, up to 23 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02650791, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2020.

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