---
title: Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma -2
nct_id: NCT04898712
overall_status: UNKNOWN
phase: PHASE2
sponsor: Unity Health Toronto
study_type: INTERVENTIONAL
primary_condition: Chronic Subdural Hematoma
countries: Canada
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04898712.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04898712"
ct_last_update_post_date: 2021-05-24
last_seen_at: "2026-05-12T07:16:11.513Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma -2

**Official Title:** Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma: An Observer-blinded, Randomized Controlled Trial

**NCT ID:** [NCT04898712](https://clinicaltrials.gov/study/NCT04898712)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 90
- **Lead Sponsor:** Unity Health Toronto
- **Collaborators:** The Physicians' Services Incorporated Foundation
- **Conditions:** Chronic Subdural Hematoma
- **Start Date:** 2021-07
- **Completion Date:** 2023-12
- **CT.gov Last Update:** 2021-05-24

## Brief Summary

Chronic subdural hematoma (CSDH), a common disease after minor head trauma, is characterized by blood collection in the subdural space, which can result in severe neurological impairment. The current standard of care is the surgical evacuation of CSDH. Although clinical and surgical outcomes are satisfying in most cases, considerable morbidity, mortality and recurrence rates of 3-31% are frequently reported. Therefore a non-surgical approach to treat CSDH is desirable. Tranexamic acid (TXA), an antifibrinolytic drug, has been shown to decrease hematoma volume in a small cohort of CSDH patients. The present study is designed to test the hypothesis that TXA can reduce the volume of CSDH. Volume measurements of residual CSDH after burr-hole surgery will be performed to quantify treatment success. The trial is designed as a double-blinded randomized controlled trial, where half of the patients will be assigned to daily intake of TXA, whereas the other half will receive placebo. The primary endpoint is defined as volume change in milliliter after 4-8 weeks of treatment. Secondary endpoints are hematoma volume at 8-12 weeks, patient safety, the number of patients with resolution of the CSDH after 4-8 and 8-12 weeks of study participation, the neurological outcome, the rate of reoperation, the time to reoperation, drug safety and compatibility, and participant quality of life (QOL).

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Diagnosis of chronic subdural hematoma (CSDH)
* Written informed consent (patient, power of attorney or substitute decision maker)
* Competence to take study medication properly and regularly or access to caregiver that is able to comply with accurate study medication administration

Exclusion Criteria:

* Hypersensitivity to TXA or any of the ingredients
* Pregnancy
* Irregular menstrual bleeding with unidentified cause
* Acquired colour vision disturbances
* Acute and chronic renal insufficiency indicated by GFR ≤ 30 mL/min
* Hematuria, caused by diseases of renal parenchyma
* Concomitant intake of hormonal contraceptives, factor IX complex concentrates, and anti-inhibitor coagulant concentrates (factor VII, activated factor IX)
* History of angioplasty with cardiac stent placement, or cardiac (including mechanical) valve placement
* Active history of stroke (hemorrhagic and ischemic), or subarachnoid hemorrhage, within the past 6 months
* Consumption coagulopathy/disseminated intravascular coagulation (DIC) in the last 7 days
* History of malignant brain tumors (glioma, metastasis and others) or seizures within the 6 months
* Contraindication to stopping full therapeutic doses of non-ASA antiplatelets, warfarin, rivaroxaban, apixaban, dabigatran, or other anticoagulant for 2 weeks after surgery
* Inability of oral drug intake or missing support to guarantee oral drug intake
* SDH as caused by intracranial hypotension resulting from CSF shunt placement
```

## Arms

- **Tranexamic Acid Arm** (EXPERIMENTAL) — Participants in the experimental arm will receive tranexamic acid (TXA) during surgery for CSDH evacuation with a single 1000mg intraoperative intravenous (IV) dose. Participants with a body weight 60-100kg will also receive a post-operative dose regimen of 500 mg TXA orally, 3 times a day (TID).

Weight deviations from this body weight range will be considered with a dose adjustment of 1000mg TXA two times a day (BID) for a body weight \>100 kg, and 500 mg TXA BID for body weight \<60kg.
- **Placebo Control Arm** (PLACEBO_COMPARATOR) — Participants in the control arm will placebo according to the same administration regimen.

## Interventions

- **Tranexamic Acid 500 MG** (DRUG) — Tranexamic Acid 500mg oral tablets
- **Placebo** (DRUG) — The placebo will consist of an identical capsule to over-encapsulated tranexamic acid oral tablet entirely filled with microcrystalline cellulose, and sealed.

## Primary Outcomes

- **Chronic subdural hematoma volume change** _(time frame: At 4-8 weeks)_ — Change in hematoma volume in mL according to CT-scan-based volume measurements comparing hematoma on CT scan performed at 4-8 weeks to hematoma on immediate post-operative CT scan.

## Secondary Outcomes

- **Chronic subdural hematoma volume change** _(time frame: At 12 weeks)_
- **Rate of adverse events (AEs)** _(time frame: At 4, 8, and 12 weeks)_
- **36-Item Short Form Survey (SF-36)** _(time frame: At 4, 8, 12 weeks)_
- **National Institutes of Health Stroke Scale (NIHSS)** _(time frame: At 4, 8, and 12 weeks)_
- **Modified Rankin Scale (mRS)** _(time frame: At 4, 8, and 12 weeks)_
- **Markwalder's grading scale (MGS)** _(time frame: At 4, 8, and 12 weeks)_
- **Rate of re-operation** _(time frame: At 4, 8, and 12 weeks)_
- **Time to reoperation** _(time frame: At 4, 8, and 12 weeks)_

## Locations (1)

- St. Michael's Hospital, Toronto, Ontario, Canada

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.st. michael's hospital|toronto|ontario|canada` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT04898712*  
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