Trial · NCT05713630
The Use of Tranexamic Acid in the Treatment of Symptomatic Subdural Hematoma
NCT05713630, Phase 3, Recruiting, Unity Health Toronto
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Use of Tranexamic Acid in the Treatment of Symptomatic Subdural Hematoma. Trials, record NCT05713630. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05713630
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Use of Tranexamic Acid in the Treatment of Symptomatic Subdural Hematoma
- NCT number
- NCT05713630
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 130 participants, estimated
- Lead sponsor
- Unity Health Toronto
- Conditions
- Subdural Hematoma
- Interventions
- Tranexamic acid (TXA), Placebo
- First posted
- 2023-02-06
- Last updated
- 2026-05-29
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) | Every 2 weeks after randomization up to 45±10 days. | A self-rated questionnaire that assesses a patient's health state in five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. |
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 - Global Health. English and French versions | Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization. | A 10-item measure that assesses an individual's general physical, mental, and social health as it is intended to globally reflect individuals' assessment of their physical and mental health in the last 7 days. |
| Secondary | PROMIS Item Bank v2.0 - Cognitive Function. English version | Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization. | A measure that assesses cognitive function that will be administered as a computer adaptive test. |
| Secondary | PROMIS Item Bank v2.0 - Physical Function. English version | Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization. | A measure that assesses self-reported capability rather than actual performance of physical activities that will be administered as a computer adaptive test. |
| Secondary | PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities. English version | Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization. | A measure that assesses the perceived ability to perform one's usual social roles and activities that will be administered as a computer adaptive test. The item bank does not use a time frame (e.g. over the past 7 days) when assessing ability to participate in social roles and activities. |
| Secondary | Subdural hematoma volume change | Baseline, 45±10 days after randomization, and 60-90 days if deemed necessary for the patient's routine care. | Change in hematoma volume in millilitres on CT scan. |
| Secondary | Number of subdural hematoma-related surgical interventions | First admission, subsequent admissions up to 180 days after randomization | |
| Secondary | Recurrence rate of SDH | 45±10 days, 60-90 days, and 180±10 days after randomization | |
| Secondary | Mortality | During the course of study up to 180±10 days after randomization | |
| Secondary | Modified Rankin Scale | Baseline, 45±10 days, 60-90 days, and 180±10 days after randomization | A 6-point disability scale used to measure the degree of disability in patients who have had a stroke. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers68
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT05713630
GET https://conductscience.org/api/trials/v1/NCT05713630/papers?page=2