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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryEuropean 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.
SecondaryPatient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 - Global Health. English and French versionsBaseline 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.
SecondaryPROMIS Item Bank v2.0 - Cognitive Function. English versionBaseline 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.
SecondaryPROMIS Item Bank v2.0 - Physical Function. English versionBaseline 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.
SecondaryPROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities. English versionBaseline 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.
SecondarySubdural hematoma volume changeBaseline, 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.
SecondaryNumber of subdural hematoma-related surgical interventionsFirst admission, subsequent admissions up to 180 days after randomization
SecondaryRecurrence rate of SDH45±10 days, 60-90 days, and 180±10 days after randomization
SecondaryMortalityDuring the course of study up to 180±10 days after randomization
SecondaryModified Rankin ScaleBaseline, 45±10 days, 60-90 days, and 180±10 days after randomizationA 6-point disability scale used to measure the degree of disability in patients who have had a stroke.

Outcomes0

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.

PMIDListed asSource
1378564BACKGROUNDPubMed
3328270BACKGROUNDPubMed
6195537BACKGROUNDPubMed
7014792BACKGROUNDPubMed
8137796BACKGROUNDPubMed
12810784BACKGROUNDPubMed
14742149BACKGROUNDPubMed
17490504BACKGROUNDPubMed
19575576BACKGROUNDPubMed
20868215BACKGROUNDPubMed

1 to 10 of 68

See all 68 papers

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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