Trial · NCT03136445
TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytopenia
NCT03136445, Phase 3, Completed, NHS Blood and Transplant; results first posted 2025-10-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytopenia. Trials, record NCT03136445. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03136445
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytopenia
- NCT number
- NCT03136445
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 616 participants, actual
- Lead sponsor
- NHS Blood and Transplant
- Conditions
- Hematologic Neoplasms, Hemorrhage, Hematopoietic Stem Cell Transplantation
- Interventions
- Tranexamic acid (TXA)., Placebo
- First posted
- 2017-05-02
- Last updated
- 2025-10-28
- Other registries' IDs
- eudract:2014-001513-35, isrctn:ISRCTN73545489
- Results first posted
- 2025-10-28
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Proportion of Patients Who Die or Have Bleeding of WHO Grade 2 or Above by WHO Criteria During the First 30 Days From the First Dose of Trial Treatment, or Planned First Dose for Those Participants Who do Not Receive Treatment. | The first 30 days from first dose of trial treatment | The proportion of patients who die or have bleeding of WHO grade 2 or above by WHO criteria during the first 30 days from the first dose of trial treatment, or planned first dose for those participants who do not receive treatment. A time-to-event analysis will be used to determine this proportion to ensure that all patients are included in the primary outcome analysis, not just those who are followed up for the full 30 days. Any patients lost to follow-up will be included in the analysis and censored at the time that they were lost. |
| Secondary | Mean (SD) Percentage of Days With WHO Grade 2 Bleeding or Above, Per Participant. | The first 30 days from first dose of trial treatment . | Number of days where WHO grade 2 or above bleeding has been recorded bleeding using WHO bleeding criteria. |
| Secondary | Time to First Episode of Bleeding of WHO Grade 2 or Greater up to Study Day 30. | The first 30 days from first dose of trial treatment. | Bleeding assessed using WHO bleeding criteria. Time to first episode of bleeding of WHO grade 2 or above was estimated using a cumulative incidence function, with death as a competing risk. The lower quartile for the time is reported as the median was not estimable. |
| Secondary | Highest Grade of Bleeding a Patient Experiences up to Study Day 30. | The first 30 days from first dose of trial treatment. | Measured using WHO bleeding criteria (The higher the grade, the most severe the bleed). Grade 0: no bleeding Grade 1: petechial bleeding Grade 2: mild blood loss (clinically significant) Grade 3: gross blood loss, requires transfusion(severe) Grade 4: debilitating blood loss, retinal or cerebral associated with fatality |
| Secondary | Number of Platelet Transfusions Per Patient up to Study Day 30. | The first 30 days from first dose of trial treatment. | Measured by number of recorded platelet transfusions per patient. |
| Secondary | Number of Red Cell Transfusions Per Patient up to Study Day 30. | The first 30 days from first dose of trial treatment. | Measured by number of recorded red cell transfusions per patient. |
| Secondary | Proportion of Patients Surviving at Least 30 Days Without a Platelet Transfusion. | The first 30 days from first dose of trial treatment. | Measured by calculating number of patients surviving at least 30 days without a platelet transfusion. |
| Secondary | Proportion of Patients Surviving at Least 30 Days Without a Red Cell Transfusion. | The first 30 days from first dose of trial treatment. | Measured by calculating the number of patients surviving at least 30 days without a red cell transfusion. |
| Secondary | Number of Participants With a Thrombotic Event From First Administration of Trial Treatment up to and Including 120 Days After the First Dose of Trial Treatment is Received (N) | Up to and including 120 days from the first administration of investigational medicinal product (IMP). | Measured by calculating number of patients developing clinically diagnosed thrombotic events within 120 days of Treatment Day 1 i.e the first day that the IMP is administered. |
| Secondary | Number of Patients Developing Veno-occlusive Disease (VOD; Sinusoidal Obstructive Syndrome, SOS) Within 60 Days of First Administration of Trial Treatment. | Up to and including 60 days from the first administration of IMP. | Measured by calculating number of patients developing Veno-occlusive Disease (VOD; Sinusoidal obstructive syndrome, SOS) within 60 days of Treatment Day 1 i.e the first day that the IMP is administered. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Proportion of Patients Who Die or Have Bleeding of WHO Grade 2 or Above by WHO Criteria During the First 30 Days From the First Dose of Trial Treatment, or Planned First Dose for Those Participants Who do Not Receive Treatment. | The first 30 days from first dose of trial treatment | Participants with primary outcome data reported | percentage of participants | NUMBER |
| SECONDARY | Mean (SD) Percentage of Days With WHO Grade 2 Bleeding or Above, Per Participant. | The first 30 days from first dose of trial treatment . | Participants with primary outcome data reported | percentage of days | MEAN |
| SECONDARY | Time to First Episode of Bleeding of WHO Grade 2 or Greater up to Study Day 30. | The first 30 days from first dose of trial treatment. | Participants with primary outcome data reported | Lower quartile for number of days | MEDIAN |
| SECONDARY | Highest Grade of Bleeding a Patient Experiences up to Study Day 30. | The first 30 days from first dose of trial treatment. | Data is only presented for participants who experienced at least one bleed | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Platelet Transfusions Per Patient up to Study Day 30. | The first 30 days from first dose of trial treatment. | Participants with primary outcome data reported | platelet units | MEDIAN |
| SECONDARY | Number of Red Cell Transfusions Per Patient up to Study Day 30. | The first 30 days from first dose of trial treatment. | Participants with primary outcome data reported | Red cell units | MEDIAN |
| SECONDARY | Proportion of Patients Surviving at Least 30 Days Without a Platelet Transfusion. | The first 30 days from first dose of trial treatment. | Participants with primary outcome data reported | proportion | NUMBER |
| SECONDARY | Proportion of Patients Surviving at Least 30 Days Without a Red Cell Transfusion. | The first 30 days from first dose of trial treatment. | Participants with primary outcome data reported | proportion | NUMBER |
| SECONDARY | Number of Participants With a Thrombotic Event From First Administration of Trial Treatment up to and Including 120 Days After the First Dose of Trial Treatment is Received (N) | Up to and including 120 days from the first administration of investigational medicinal product (IMP). | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients Developing Veno-occlusive Disease (VOD; Sinusoidal Obstructive Syndrome, SOS) Within 60 Days of First Administration of Trial Treatment. | Up to and including 60 days from the first administration of IMP. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group78
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
The Proportion of Patients Who Die or Have Bleeding of WHO Grade 2 or Above by WHO Criteria During the First 30 Days From the First Dose of Trial Treatment, or Planned First Dose for Those Participants Who do Not Receive Treatment. | Intervention Arm | 31.7 | 95% Confidence Interval 26.6 to 37.4 | percentage of participants | |
The Proportion of Patients Who Die or Have Bleeding of WHO Grade 2 or Above by WHO Criteria During the First 30 Days From the First Dose of Trial Treatment, or Planned First Dose for Those Participants Who do Not Receive Treatment. | Control Arm | 34.2 | 95% Confidence Interval 29.0 to 40.0 | percentage of participants | |
| Mean (SD) Percentage of Days With WHO Grade 2 Bleeding or Above, Per Participant. | Intervention Arm | 3.1 | Standard Deviation 9.5 | percentage of days | |
| Mean (SD) Percentage of Days With WHO Grade 2 Bleeding or Above, Per Participant. | Control Arm | 3.2 | Standard Deviation 7.8 | percentage of days | |
| Time to First Episode of Bleeding of WHO Grade 2 or Greater up to Study Day 30. | Intervention Arm | NA | Inter-Quartile Range 10.5 to NA | Lower quartile for number of days | |
| Time to First Episode of Bleeding of WHO Grade 2 or Greater up to Study Day 30. | Control Arm | NA | Inter-Quartile Range 8.5 to NA | Lower quartile for number of days | |
| Highest Grade of Bleeding a Patient Experiences up to Study Day 30. | Intervention Arm | Grade 0 | 7 | Participants | |
| Highest Grade of Bleeding a Patient Experiences up to Study Day 30. | Control Arm | Grade 0 | 6 | Participants | |
| Highest Grade of Bleeding a Patient Experiences up to Study Day 30. | Intervention Arm | Grade unassigned | 0 | Participants | |
| Highest Grade of Bleeding a Patient Experiences up to Study Day 30. | Control Arm | Grade unassigned | 1 | Participants |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intervention Arm | 310 | |
| Overall Study | STARTED | Control Arm | 306 | |
| Overall Study | COMPLETED | Intervention Arm | 300 | |
| Overall Study | COMPLETED | Control Arm | 297 | |
| Overall Study | NOT COMPLETED | Intervention Arm | 10 | |
| Overall Study | NOT COMPLETED | Control Arm | 9 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Venous thromboembolisms | Vascular disorders | Intervention Arm | 7 | 300 | |
| other | Venous thromboembolisms | Vascular disorders | Control Arm | 4 | 297 | |
| other | Arterial ischaemic events | Vascular disorders | Intervention Arm | 1 | 300 | |
| other | Arterial ischaemic events | Vascular disorders | Control Arm | 1 | 297 | |
| serious | Sepsis (at least one event) | Infections and infestations | Intervention Arm | 25 | 300 | |
| serious | Sepsis (at least one event) | Infections and infestations | Control Arm | 27 | 297 | |
| serious | Organ Failure (at least one event) | General disorders | Intervention Arm | 4 | 300 | |
| serious | Organ Failure (at least one event) | General disorders | Control Arm | 6 | 297 | |
| serious | GvHD (at least one event) | Immune system disorders | Intervention Arm | 5 | 300 | |
| serious | GvHD (at least one event) | Immune system disorders | Control Arm | 7 | 297 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intervention Arm | 23 | 300 |
| Total, all-cause mortality | Control Arm | 14 | 297 |
| Total, other adverse events | Intervention Arm | 8 | 300 |
| Total, other adverse events | Control Arm | 5 | 297 |
| Total, serious adverse events | Intervention Arm | 77 | 300 |
| Total, serious adverse events | Control Arm | 82 | 297 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intervention Arm vs Control Arm: Number of Patients Developing Veno-occlusive Disease (VOD; Sinusoidal Obstructive Syndrome, SOS) Within 60 Days of First Administration of Trial Treatment. | Trial comparisons |
Intervention Arm vs Control Arm: Number of Participants With a Thrombotic Event From First Administration of Trial Treatment up to and Including 120 Days After the First Dose of Trial Treatment is Received (N) | Trial comparisons |
| Intervention Arm vs Control Arm: deaths from any cause | Trial comparisons |
| Intervention Arm vs Control Arm: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03136445
GET https://conductscience.org/api/trials/v1/NCT03136445/results?page=2