Tranexamic Acid for Subdural Hematoma

(TRACS Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by David Mathieu, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Must not be taking: Anticoagulants, Hormone therapy

Disqualifiers: Thromboembolic disease, Malignancy, Pregnancy, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

BACKGROUND Chronic subdural hematoma (CSDH) is one of the most frequent reasons for cranial neurosurgical consult. There is no widely accepted medical treatment for CSDH. This trial will investigate whether Tranexamic Acid (TXA) can increase the rate of CSDH resolution following conservative management, lower the number of required surgical procedures and decrease the rate of CSDH recurrence following surgical evacuation. TRACS is a double blind, randomized, parallel-design, placebo-controlled, phase IIB study designed to provide preliminary efficacy data as well as feasibility, safety and incidence data required to plan a larger definitive phase III trial. METHODS Consecutive patients presenting at the Centre Hospitalier Universitaire de Sherbrooke with a recent (\< 14 days) diagnosis of subdural hematoma with a chronic component will be screened for eligibility. Exclusion criteria include specific risk factors for thromboembolic disease, anticoagulant use or contraindication to TXA. A total of 130 patients will be randomized to receive either 750 mg of TXA daily or placebo until complete radiological resolution of the CSDH or for a maximum of 20 weeks. CSDH volume will be measured on serial CT scanning. Cognitive function tests, quality of life questionnaires as well as functional autonomy assessments will be performed at enrollment, 10 weeks follow-up and 3 months post-treatment follow-up. During the treatment period, patients will undergo standard CSDH management with surgery being performed at the discretion of the treating physician. If surgery is performed, the CSDH and its outer membrane will be sampled for in vitro analysis. The primary outcome is the rate of CSDH resolution at 20 weeks without intervening unplanned surgical procedure. Secondary outcomes include CSDH volume, incidence of surgical evacuation procedures, CSDH recurrence, cognitive functions, functional autonomy, quality of life, incidence of complications and length of hospital stay. Planned subgroup analyses will be performed for conservatively vs surgically-managed subjects and highly vs poorly vascularised CSDH. DISCUSSION CSDH is a frequent and morbid condition for which an effective medical treatment has yet to be discovered. The TRACS trial will be the first prospective study of TXA for CSDH.

Will I have to stop taking my current medications?

The trial requires that you stop taking anticoagulant medications to participate. If you are on such medications, you would need to discontinue them before joining the trial.

What data supports the effectiveness of the drug Tranexamic Acid (TXA) for subdural hematoma?

Research on Tranexamic Acid (TXA) for chronic subdural hematomas (CSDH) shows mixed results. While some studies suggest TXA might help reduce recurrence rates after surgery, others indicate it may not be effective and could increase complications. Additionally, TXA has been shown to reduce mortality in patients with mild to moderate traumatic brain injuries, which may suggest potential benefits in similar conditions.

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Is tranexamic acid generally safe for humans?

Tranexamic acid (TXA) has been used in various medical conditions, but in a study on chronic subdural hematoma, it was associated with a higher rate of complications compared to a control group. While the study was small, it suggests that TXA might increase the odds of complications in this context.

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How does the drug tranexamic acid differ from other treatments for subdural hematoma?

Tranexamic acid (TXA) is unique because it is an antifibrinolytic agent, meaning it helps prevent the breakdown of blood clots, which may reduce the recurrence of subdural hematomas. Unlike other treatments that often involve surgery, TXA offers a potential non-surgical option for managing this condition.

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Eligibility Criteria

This trial is for patients recently diagnosed (within the last 14 days) with chronic subdural hematoma. It's not suitable for those with acute hematomas, thrombotic diseases, recent strokes or heart surgeries, active cancer treatments, certain genetic disorders related to blood clotting, or women who are pregnant/breastfeeding.

Inclusion Criteria

You have a long-lasting collection of blood outside the brain.

Diagnosis within the last 14 days

Exclusion Criteria

You have a metal heart valve.

I have a recent brain bleed without any old bleeding.

I have a genetic condition that increases my risk of blood clots.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive either 750 mg of Tranexamic Acid daily or placebo until complete radiological resolution of the CSDH or for a maximum of 20 weeks

Up to 20 weeks

Regular visits for CT scans and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including cognitive function tests, quality of life questionnaires, and functional autonomy assessments

12 weeks

Follow-up visits at 10 weeks and 3 months post-treatment

Participant Groups

The study tests if Tranexamic Acid can help resolve chronic subdural hematomas without surgery and prevent recurrence after surgical treatment. Participants will receive either TXA or a placebo alongside standard care in this double-blind phase IIB trial.

Group I: Tranexamic acid Experimental Treatment 1 Intervention

Tranexamic acid 750 mg daily until complete radiological resolution of the chronic subdural hematoma or a maximum of 20 weeks.

Group II: Placebo Placebo Group 1 Intervention

Placebo tablet daily until complete radiological resolution of the chronic subdural hematoma or a maximum of 20 weeks.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Alberta Hospital Edmonton, Canada

Centre Hospitalier Universitaire de Sherbrooke Sherbrooke, Canada

Centre Hospitalier Affilié Universitaire de Québec Québec, Canada

Who Is Running the Clinical Trial?

Centre de recherche du Centre hospitalier universitaire de Sherbrooke Lead Sponsor

Université de Sherbrooke Collaborator

References

1. Germany pubmed.ncbi.nlm.nih.gov

Effect of postoperative tranexamic acid on recurrence rate and complications in chronic subdural hematomas patients: preliminary results of a randomized controlled clinical trial. [2023] Chronic subdural hematoma (CSDH) is a frequent neurosurgical disease which mainly affects elderly patients. Tranexamic acid (TXA) has been hypothesized as an oral agent to avoid CSDH progression and/or recurrence. We performed an evaluation to determine whether the postoperative use of TXA reduces recurrence rate. A prospective, randomized, and controlled trial. Patients with unilateral or bilateral chronic subdural hematoma undergoing surgical treatment by burr-hole were randomized as to whether or not to use TXA in the postoperative period. We evaluated image and clinical recurrence of CSDH at follow up of 6 months and potential clinical and/or surgical complications impact of TXA. Twenty-six patients were randomized to the control group (52%) and twenty-four patients to the TXA group (48%). Follow-up ranged from 3 to 16 months. There were no significant difference between baseline data in groups regarding to age, gender, use of antiplatelet or anticoagulants, smoking, alcoholism, systemic arterial hypertension, diabetes mellitus, hematoma laterality, hematoma thickness, and drain use. Clinical and radiological recurrence occurred in three patients (6%), being two cases in TXA group (8.3%) and 1 in control group (3.8%). Postoperative complications occurred in two patients during follow-up (4%), being both cases in TXA group (8.3%), and none in the control group. Although TXA group had a higher recurrence rate (8.3%), there was no statistically significant difference between the two groups. Moreover, TXA group had two complications while control group had no complications. Although limited by experimental nature of study and small sample, our current data suggest that TXA should not be used as a potential agent to avoid recurrences of CSDH and might increase complication odds.

2. England pubmed.ncbi.nlm.nih.gov

Tranexamic Acid in Chronic Subdural Hematomas (TRACS): study protocol for a randomized controlled trial. [2022] Chronic subdural hematoma (CSDH) is one of the most frequent reason for cranial neurosurgical consultation. There is no widely accepted medical treatment for this condition. Herein, we present the protocol for the Tranexamic Acid (TXA) in Chronic Subdural Hematomas (TRACS) trial aiming at determining whether TXA can increase the rate of CSDH resolution following conservative management, lower the number of required surgical procedures and decrease the rate of CSDH recurrence following surgical evacuation.

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Role of Adjunctive Tranexamic Acid in Facilitating Resolution of Chronic Subdural Hematoma after Surgery. [2023] Chronic subdural hematoma (CSDH) is a common neurosurgical disease and generally treated with burr-hole surgery alone. Tranexamic acid (TXA) is an antifibrinolytic agent that potentially reduces recurrence rates and the residual hematoma volume. However, the role of postoperative TXA medication remains unclear to date. This study aimed to verify the effectiveness of adjunctive TXA in the view of early hematoma resolution.

4. United States pubmed.ncbi.nlm.nih.gov

Administration of Tranexamic Acid After Burr Hole Craniotomy Reduced Postoperative Recurrence of Chronic Subdural Hematoma in a Japanese Regional Population. [2023] Although tranexamic acid (TXA) has occasionally been used to prevent postoperative recurrence of chronic subdural hematoma (CSDH) after burr hole craniotomy (BC), robust evidence of its efficacy has been lacking.

5. United States pubmed.ncbi.nlm.nih.gov

Tranexamic acid and traumatic brain injuries. [2021] The CRASH-3 trial examined the use of tranexamic acid (TXA) in patients with intracranial bleeding secondary to traumatic brain injury. The trial demonstrated that TXA, an antifibrinolytic medication, reduces mortality in patients with mild to moderate head injuries. However, because of the trial's multiple limitations, TXA cannot yet be called the gold standard.

6. England pubmed.ncbi.nlm.nih.gov

Tranexamic acid for patients with aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis of 2991 patients. [2022] We aimed to synthesize evidence from published clinical trials on the efficacy and safety of tranexamic acid (TXA) administration in patients with aneurysmal subarachnoid hemorrhage (aSAH).

7. United States pubmed.ncbi.nlm.nih.gov

The Outcome of Medical Management of Chronic Subdural Hematoma with Tranexamic Acid - A Prospective Observational Study. [2021] The conservative management of Chronic subdural hematoma (CSDH) is controversial. Many drugs have been tried in the conservative management of CSDH. Tranexamic acid (Txa) is one such drug in the armamentarium for conservative management of CSDH. We conducted a prospective observational study about treatment of CSDH with Txa.

8. England pubmed.ncbi.nlm.nih.gov

Tranexamic acid for chronic subdural hematoma. [2022] There is no consensus on optimal treatment for a chronic subdural hematoma (cSDH). In patients with only moderate symptoms treatment with tranexamic acid (TXA) has been suggested. We report off-label use of TXA in seven patients.