Hematological Malignancies Treated With Intensive ChemotherapyPhase 2TTRAP-BleedingNCT03801122
Evolution of Thromboelastography During Tranexamic Acid Treatment
A Phase 2 study testing Tranexamic acid in people with Hematological Malignancies Treated With Intensive Chemotherapy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Patients with hematological malignancies are at increased risk of bleeding, especially during intensive chemotherapy. The aim of this study is to compare by thromboelastography changes during the intensive chemotherapy in patients with hematological malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Malignancies Treated With Intensive Chemotherapy
- What is being tested?
- Tranexamic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 5 Mar 2019to 11 Jul 2022
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient affiliated to a social security regimen or beneficiary of the same
- Signed written informed consent form
- Confirmed diagnosis of a hematological malignancy and undergoing intensive chemotherapy
- Expected to experience hypoproliferative thrombocytopenia resulting in a platelet count of ≤10 G/L for ≥ 5 days
Who cannot join
- Pregnant women
- Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent
- Refractoriness to platelet transfusion or requirement for a specific type of platelet transfusion (ABO-compatible, plasma-free)
- Ongoing anticoagulant therapy or antiplatelet therapy at the time of enrolment
- Treatment with any pro-coagulant agent within 48 hours of enrolment, or enrolment in other trials involving platelet transfusions, platelet growth factors, or presentation of a known hypercoagulable state
- Diagnosis of arterial or venous thromboembolic disease within the previous year
Show all 9Show fewer
- Patient experiencing a bleeding event WHO grade ≥ 2 within 7 days before inclusion
- contra-indications to tranexamic acid (allergy, history of seizures, creatinine clearance < 30 mL/min)
- Refusing participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Thromboelastography During Tranexamic Acid Treatment in Preventing Bleeding in Patients With Haematological Malignancies Presenting Severe Thrombocytopenia (TTRAP-bleeding)
Patients with hematological malignancies are at increased risk of bleeding, especially during intensive chemotherapy. The aim of this study is to compare by thromboelastography changes during the intensive chemotherapy in patients with hematological malignancies.
Read the detailed description
Patients with hematological malignancies often develop low platelet counts either as a consequence of the disease or the treatment by chemotherapy or stem cell transplantation. Platelet transfusions are commonly given to raise any low platelet count and reduce the risk of clinical bleeding (prophylaxis) or stop active bleeding (therapy). The last studies have showed that many patients continue to experience bleeding, despite the use of platelet transfusions. Tranexamic acid is an antifibrinolytic agent. It reduces the breakdown of clots formed. This treatment is widely used in medicine (e.g. emergency, surgery, post-partum) and decreases blood loss and the use of red cell transfusions. The purpose of this study is to test different doses of tranexamic acid (full dose: 3g/day and half dose (1.5g/day) and to study its effect by thromboelastography, with the aim to determine the optimal posology for further clinical studies.
- Being tested
- Tranexamic acid
- Keywords
- Tranexamic acid, bleeding, hematological malignancies, thrombocytopenia
- Medical subject headings
- Hemorrhage, Hematologic Neoplasms, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Administration of tranexamic acid, with 3 injections/8 hours.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid 3g/day | Experimental | Administration of tranexamic acid 3g/day, with 3 injections/8 hours. Receives: Drug: Tranexamic acid |
| Tranexamic acid 1.5g/day | Experimental | Administration of tranexamic acid 1.5g/day, with 3 injections/8 hours. Receives: Drug: Tranexamic acid |
| No treatment | No intervention | No treatment (no administration of tranexamic acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of amplitude observed in thromboelastography
Amplitude levels observed in thromboelastography will be reported
Measured: 30 days
Secondary outcomes (6)
Time at the beginning of the clot
Time at the beginning of the clot will be reported in minutes
Measured: 30 minutes
Clot formation time
Clot formation time will ne reported in minutes
Measured: 30 minutes
Alpha angle
Alpha angle will be measured in degrees
Measured: 30 days
Percentage of lysis after 30min
Percentage of lysis after 30min will be measured
Measured: 30 minutes
Proportion of patients experiencing bleeding of WHO (World Health Organisation ) grade 2 or above
Proportion of patients experiencing bleeding of WHO (World Health Organisation ) grade 2 or above will be reported
Measured: 30 days
Number of adverse events
Number of adverse events will be reported
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start5 Mar 2019
- Primary completion9 Mar 2022
- Study completion11 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological Malignancies Treated With Intensive ChemotherapyStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1 : Tranexamic acid 3g/day Arm 2 : Tranexamic acid 1.5g/day Arm 3 : No tranexamic acid
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Cancérologie de la Loire
- Responsible party
- Sponsor
- Investigators
- Emilie Chalayer, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801122
- Sponsor's protocol ID
- 2018-1201
- Other IDs
- 2018-004756-38, 2018
- Acronym
- TTRAP-Bleeding
- Status last verified
- May 2023
- First submitted
- 20 Dec 2018
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Thromboelastography During Tranexamic Acid Treatment in Preventing Bleeding in Patients With Haematological Malignancies Presenting Severe Thrombocytopenia (TTRAP-bleeding)
- ClinicalTrials.gov ID
- NCT03801122
- Acronym / sponsor ID
- TTRAP-Bleeding / 2018-1201
- Keywords
- Tranexamic acid, bleeding, hematological malignancies, thrombocytopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Institut de Cancérologie de la Loire
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 9 Mar 2022 (actual)
- Study completion
- 11 Jul 2022 (actual)
- First posted
- 11 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with hematological malignancies are at increased risk of bleeding, especially during intensive chemotherapy. The aim of this study is to compare by thromboelastography changes during the intensive chemotherapy in patients with hematological malignancies.
Detailed description
Patients with hematological malignancies often develop low platelet counts either as a consequence of the disease or the treatment by chemotherapy or stem cell transplantation. Platelet transfusions are commonly given to raise any low platelet count and reduce the risk of clinical bleeding (prophylaxis) or stop active bleeding (therapy). The last studies have showed that many patients continue to experience bleeding, despite the use of platelet transfusions. Tranexamic acid is an antifibrinolytic agent. It reduces the breakdown of clots formed. This treatment is widely used in medicine (e.g. emergency, surgery, post-partum) and decreases blood loss and the use of red cell transfusions. The purpose of this study is to test different doses of tranexamic acid (full dose: 3g/day and half dose (1.5g/day) and to study its effect by thromboelastography, with the aim to determine the optimal posology for further clinical studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Arm 1 : Tranexamic acid 3g/day Arm 2 : Tranexamic acid 1.5g/day Arm 3 : No tranexamic acid
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid 3g/day | Experimental | Drug: Tranexamic acidAdministration of tranexamic acid 3g/day, with 3 injections/8 hours. |
| Tranexamic acid 1.5g/day | Experimental | Drug: Tranexamic acidAdministration of tranexamic acid 1.5g/day, with 3 injections/8 hours. |
| No treatment | No intervention | –No treatment (no administration of tranexamic acid) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient affiliated to a social security regimen or beneficiary of the same
- Signed written informed consent form
- Confirmed diagnosis of a hematological malignancy and undergoing intensive chemotherapy
- Expected to experience hypoproliferative thrombocytopenia resulting in a platelet count of ≤10 G/L for ≥ 5 days
Key exclusion criteria (9 listed)
- Pregnant women
- Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent
- Refractoriness to platelet transfusion or requirement for a specific type of platelet transfusion (ABO-compatible, plasma-free)
- Ongoing anticoagulant therapy or antiplatelet therapy at the time of enrolment
- Treatment with any pro-coagulant agent within 48 hours of enrolment, or enrolment in other trials involving platelet transfusions, platelet growth factors, or presentation of a known hypercoagulable state
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 acidAdministration of tranexamic acid, with 3 injections/8 hours. | Drug | Tranexamic acid 1.5g/day, Tranexamic acid 3g/day |
Primary outcome
Level of amplitude observed in thromboelastography
Time frame: 30 days
Amplitude levels observed in thromboelastography will be reported
6 secondary outcomes
Time at the beginning of the clot
Time frame: 30 minutes
Clot formation time
Time frame: 30 minutes
Alpha angle
Time frame: 30 days
Percentage of lysis after 30min
Time frame: 30 minutes
Proportion of patients experiencing bleeding of WHO (World Health Organisation ) grade 2 or above
Time frame: 30 days
Number of adverse events
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
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.
Emilie Chalayer, MD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tranexamic acid in people with Hematological Malignancies Treated With Intensive Chemotherapy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 4 inclusion and 9 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Level of amplitude observed in thromboelastography (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2023; AzTrials last refreshed its copy on 31 Oct 2026.