ThrombocytopeniaPhase 3A-TREATNCT02578901
American Trial Using Tranexamic Acid in Thrombocytopenia
A Phase 3 study testing Tranexamic Acid in people with Thrombocytopenia, run by University of Washington at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the usefulness of antifibrinolytic therapy with tranexamic acid (TXA) in preventing bleeding in patients who are thrombocytopenic due to primary bone marrow disorders or chemotherapy, immunotherapy and/or radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopenia
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2016to 11 Jun 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be ≥ 18 years of age
- Confirmed diagnosis of a hematologic malignancy or aplasia
- Undergoing or planned chemotherapy, immunotherapy, or hematopoietic stem cell transplantation
- Anticipated to have hypoproliferative thrombocytopenia resulting in a platelet count of ≤ 10,000/microliters for ≥ 5 days
- Able to provide informed consent and comply with treatment and monitoring, or having a Legally Authorized Representative (LAR)
Who cannot join
- Diagnosis of acute promyelocytic leukemia undergoing induction chemotherapy
- History of ITP, TTP or HUS
- Subjects receiving L-asparaginase as part of their current cycle of treatment
- Subjects with a past history or current diagnosis of arterial or venous thromboembolic disease including acute coronary syndrome, peripheral vascular disease and retinal arterial or venous thrombosis (except when a prior history of central line thrombosis has resolved)
- Subjects with a diagnosis/previous history of sinusoidal obstruction syndrome (also called veno-occlusive disease)
- Subjects receiving any pro-coagulant agents (e.g. DDAVP, recombinant Factor VIIa or Prothrombin Complex Concentrates (PCC) and/or an antifibrinolytic agent within 48 hours of enrollment, or with known hypercoagulable state
Show all 22Show fewer
- Known inherited or acquired bleeding disorder including, but not limited to:
- Acquired storage pool deficiency
- Paraproteinemia with platelet inhibition
- Known inherited or acquired prothrombotic disorders, including antiphospholipid syndrome. Those with lupus anticoagulant or positive antiphospholipid serology without thrombosis are not excluded.
- Subjects receiving anticoagulant therapy or anti-platelet therapy (except when receiving prophylactic anticoagulant or low dose aspirin therapy for prophylaxis only with a plan to discontinue when the platelet count falls below 50,000)
- Patients with DIC according to the patient's physician
- Subjects with WHO Grade 2 bleeding or greater within 48 hours prior to activation
- Subjects requiring a platelet transfusion threshold > 10,000/microliters at time of randomization
- Subjects with anuria (defined as urine output < 10mls/hr over 24 hours)
- Subjects on dialysis
- Subjects with creatinine ≥5.7mg/dL
- Subjects who are pregnant or nursing or unwilling to use contraception during and for 30 days after taking the study drug (both males and females)
- Subjects enrolled in other trials involving platelet transfusions, anti-fibrinolytics, platelet growth factors or other pro-coagulant agents.
- Known allergy to tranexamic acid
- Having been previously randomized in this study at any stage of their treatment
- Subjects who are unwilling to accept blood or blood component transfusions
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of North Carolina
Chapel Hill, North Carolina, 21599
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of Washington
Seattle, Washington, 98195
About this study
Official title: American Trial Using Tranexamic Acid in Thrombocytopenia (A-TREAT)
The purpose of this study is to evaluate the usefulness of antifibrinolytic therapy with tranexamic acid (TXA) in preventing bleeding in patients who are thrombocytopenic due to primary bone marrow disorders or chemotherapy, immunotherapy and/or radiation therapy.
Read the detailed description
The purpose of this study is to conduct a prospective, randomized, blinded, placebo controlled trial to evaluate the usefulness of antifibrinolytic therapy with tranexamic acid in preventing bleeding in patients who are thrombocytopenic due to primary bone marrow disorders or chemotherapy, immunotherapy and/or radiation therapy. The results of this study will change practice by providing evidence as to whether or not TXA is effective and safe treatment when used as an adjunct to platelet transfusion therapy in the thrombocytopenic patient.
- Conditions
- Thrombocytopenia
- Being tested
- Tranexamic Acid, Placebo
- Keywords
- Thrombocytopenia, Tranexamic Acid, TXA, Chemotherapy induced thrombocytopenia
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called TXA
Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, TXA 1.0 gram will be administered. When given PO, TXA 1.3 grams will be administered
PlaceboDrug
Also called NS
Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, Normal Saline will be administered. When given PO, placebo pills will be administered
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid (TXA) | Active comparator | IV or PO administered after meeting inclusion/exclusion criteria Receives: Drug: Tranexamic Acid |
| Placebo | Placebo comparator | IV Normal Saline or PO placebo pills administered after meeting inclusion/exclusion criteria Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding Within 30 Days
Proportion of patients with bleeding of WHO grade 2 or above, over the study period of 30 days after activation of study drug.
Measured: 30 days after activation of study drug
Secondary outcomes (2)
Number of Platelet Transfusions
Number of platelet transfusions per patient during the first 30 days post prescription activation of study drug
Measured: 30 days after activation of study drug
Number of Days Alive and Without WHO Grade 2 Bleeding
Number of days alive and without WHO grade 2 bleeding or greater during the first 30 days post activation of study drug
Measured: during the first 30 days post activation of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startJun 2016
- Primary completionMar 2020
- Study completion11 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Susanne May, University of Washington
- Investigators
- Terry Gernsheimer, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578901
- Sponsor's protocol ID
- STUDY00003329
- Other IDs
- 1U01HL122272-01A1
- Acronym
- A-TREAT
- Status last verified
- Feb 2021
- First submitted
- 15 Oct 2015
- Last updated
- 24 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Anonymized public data set will be available after publication of primary results
Publications
Poston JN, Brown SP, Ilich A, Ginsburg AS, Herren H, El Kassar N, Jensen CE, Triulzi DJ, Key NS, May S, Gernsheimer TB. Fewer severe infections with tranexamic acid in patients with hematologic malignancies. Res Pract Thromb Haemost. 2024 Mar 1;8(2):102358. doi: 10.1016/j.rpth.2024.102358. eCollection 2024 Feb.
PubMed 38666065Ilich A, Gernsheimer TB, Triulzi DJ, Herren H, Brown SP, Holle LA, Lucas AT, de Laat B, El Kassar N, Wolberg AS, May S, Key NS. Absence of hyperfibrinolysis may explain lack of efficacy of tranexamic acid in hypoproliferative thrombocytopenia. Blood Adv. 2023 Mar 28;7(6):900-908. doi: 10.1182/bloodadvances.2022008255.
PubMed 36044391
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- American Trial Using Tranexamic Acid in Thrombocytopenia (A-TREAT)
- ClinicalTrials.gov ID
- NCT02578901
- Acronym / sponsor ID
- A-TREAT / STUDY00003329
- Conditions
- Thrombocytopenia
- Keywords
- Thrombocytopenia, Tranexamic Acid, TXA, Chemotherapy induced thrombocytopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2016 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- 11 Jun 2020 (actual)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Posted 24 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the usefulness of antifibrinolytic therapy with tranexamic acid (TXA) in preventing bleeding in patients who are thrombocytopenic due to primary bone marrow disorders or chemotherapy, immunotherapy and/or radiation therapy.
Detailed description
The purpose of this study is to conduct a prospective, randomized, blinded, placebo controlled trial to evaluate the usefulness of antifibrinolytic therapy with tranexamic acid in preventing bleeding in patients who are thrombocytopenic due to primary bone marrow disorders or chemotherapy, immunotherapy and/or radiation therapy. The results of this study will change practice by providing evidence as to whether or not TXA is effective and safe treatment when used as an adjunct to platelet transfusion therapy in the thrombocytopenic patient.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid (TXA) | Active comparator | Drug: Tranexamic AcidIV or PO administered after meeting inclusion/exclusion criteria |
| Placebo | Placebo comparator | Drug: PlaceboIV Normal Saline or PO placebo pills administered after meeting inclusion/exclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be ≥ 18 years of age
- Confirmed diagnosis of a hematologic malignancy or aplasia
- Undergoing or planned chemotherapy, immunotherapy, or hematopoietic stem cell transplantation
- Anticipated to have hypoproliferative thrombocytopenia resulting in a platelet count of ≤ 10,000/microliters for ≥ 5 days
- Able to provide informed consent and comply with treatment and monitoring, or having a Legally Authorized Representative (LAR)
Key exclusion criteria (22 listed)
- Diagnosis of acute promyelocytic leukemia undergoing induction chemotherapy
- History of ITP, TTP or HUS
- Subjects receiving L-asparaginase as part of their current cycle of treatment
- Subjects with a past history or current diagnosis of arterial or venous thromboembolic disease including acute coronary syndrome, peripheral vascular disease and retinal arterial or venous thrombosis (except when a prior history of central line thrombosis has resolved)
- Subjects with a diagnosis/previous history of sinusoidal obstruction syndrome (also called veno-occlusive disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic AcidAlso: TXADoses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, TXA 1.0 gram will be administered. When given PO, TXA 1.3 grams will be administered | Drug | Tranexamic Acid (TXA) |
| PlaceboAlso: NSDoses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, Normal Saline will be administered. When given PO, placebo pills will be administered | Drug | Placebo |
Primary outcome
Bleeding Within 30 Days
Time frame: 30 days after activation of study drug
Proportion of patients with bleeding of WHO grade 2 or above, over the study period of 30 days after activation of study drug.
2 secondary outcomes
Number of Platelet Transfusions
Time frame: 30 days after activation of study drug
Number of Days Alive and Without WHO Grade 2 Bleeding
Time frame: during the first 30 days post activation of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38666065Poston JN, Brown SP, Ilich A, Ginsburg AS, Herren H, El Kassar N, Jensen CE, Triulzi DJ, Key NS, May S, Gernsheimer TB. Fewer severe infections with tranexamic acid in patients with hematologic malignancies. Res Pract Thromb Haemost. 2024 Mar 1;8(2):102358. doi: 10.1016/j.rpth.2024.102358. eCollection 2024 Feb.
- Derived from this study: PubMed 36044391Ilich A, Gernsheimer TB, Triulzi DJ, Herren H, Brown SP, Holle LA, Lucas AT, de Laat B, El Kassar N, Wolberg AS, May S, Key NS. Absence of hyperfibrinolysis may explain lack of efficacy of tranexamic acid in hypoproliferative thrombocytopenia. Blood Adv. 2023 Mar 28;7(6):900-908. doi: 10.1182/bloodadvances.2022008255.
- Individual participant dataSharing planned: Yes. Anonymized public data set will be available after publication of primary results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry Gernsheimer, MD principal investigator
University of Washington
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic Acid in people with Thrombocytopenia, run by University of Washington at 3 sites in United States.
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 5 inclusion and 22 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 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 24 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Bleeding Within 30 Days (time frame: 30 days after activation of study drug). 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 NCT02578901, which also lists 2 linked publications.
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 24 Mar 2021.