Tranexamic Acid for Subdural Hematoma

(TRACS Trial)

Not currently recruiting at 2 trial locations

Overseen By David Mathieu, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

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 This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 11

Duration: Up to 20 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Tranexamic Acid (TXA) can more effectively shrink chronic subdural hematomas (collections of blood on the brain's surface), reduce the need for surgery, and prevent recurrence after surgery. Participants will receive either TXA or a placebo (a dummy treatment) to assess TXA's benefits. The trial seeks individuals diagnosed with a subdural hematoma containing a chronic component within the last two weeks. As a Phase 2, Phase 3 trial, this research evaluates TXA's effectiveness in a smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potential advancements in treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Tranexamic Acid (TXA) is generally safe for people with chronic subdural hematoma (CSDH), a type of brain bleed. Some studies suggest that TXA can reduce the chance of the hematoma returning without causing more complications, indicating that most people tolerate it well. One study indicated that TXA did not increase the risk of side effects. However, results can vary between studies, so research continues to fully understand its safety. Overall, TXA appears to be a promising treatment option, as it has not been linked to major negative effects in these studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for subdural hematoma?

Unlike standard treatments for chronic subdural hematoma, which often involve surgical intervention, tranexamic acid offers a non-surgical approach by using a medication that helps stabilize blood clots. Researchers are excited about tranexamic acid because it works by preventing the breakdown of fibrin, a protein that is crucial for blood clot stability. This mechanism of action could potentially reduce the size of the hematoma without invasive procedures, offering a more accessible and less risky treatment option for patients.

What evidence suggests that Tranexamic Acid might be an effective treatment for subdural hematoma?

In this trial, participants will receive either Tranexamic Acid (TXA) or a placebo to treat chronic subdural hematoma (CSDH), a condition where blood collects on the brain's surface. Research has shown that TXA can help treat CSDH, with studies finding that it may greatly reduce the chances of recurrence. In some small studies, TXA helped the body naturally clear the hematoma. Evidence also suggests that TXA might reduce the need for surgery in people with CSDH. While results can vary between studies, most agree that TXA is a promising treatment option for this condition. ^{1 2 3 6 7}

Who Is on the Research Team?

David Mathieu, M.D.

Principal Investigator

Université de Sherbrooke

Are You a Good Fit for This Trial?

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

Diagnosis within the last 14 days

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Tranexamic Acid

Trial Overview 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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Lead Sponsor

Trials

64

Recruited

33,600+

Université de Sherbrooke

Collaborator

Trials

317

Recruited

79,300+

Published Research Related to This Trial

The TRACS trial is a multicenter, double-blind study involving 130 patients to evaluate the efficacy of Tranexamic Acid (TXA) in promoting the resolution of chronic subdural hematomas (CSDH) without the need for surgery, aiming for results within 20 weeks.

This trial will assess not only the rate of CSDH resolution but also the impact of TXA on surgical intervention rates, recurrence, cognitive function, and quality of life, making it a comprehensive approach to understanding TXA's potential benefits in managing CSDH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tranexamic Acid in Chronic Subdural Hematomas (TRACS): study protocol for a randomized controlled trial. Iorio-Morin, C., Blanchard, J., Richer, M., et al.[2022]

In a study of 6647 elderly patients who underwent burr hole craniotomy for chronic subdural hematoma, oral administration of tranexamic acid (TXA) significantly reduced the need for repeat surgery, with only 6.5% of patients in the TXA group requiring a second procedure compared to 16.8% in the control group.

The use of TXA did not increase the risk of death or thrombosis, indicating that it is a safe option for preventing postoperative recurrence in this patient population.

NCBI (Pubmed)

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. Miyakoshi, A., Nakatani, E., Kaneda, H., et al.[2023]

In a study of 240 patients with chronic subdural hematoma (CSDH), the use of tranexamic acid (TXA) as an adjunctive treatment significantly accelerated the resolution of the hematoma, with a median resolution time that was notably faster compared to those not receiving TXA (p<0.001).

The recurrence rate of CSDH was lowest in the TXA group at 2.4%, suggesting that TXA may help reduce the chances of hematoma re-accumulation, although the difference was not statistically significant due to the small number of recurrences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Adjunctive Tranexamic Acid in Facilitating Resolution of Chronic Subdural Hematoma after Surgery. Yang, K., Kim, KH., Lee, HJ., et al.[2023]

In a three-year study involving 27 patients with chronic subdural hematoma (CSDH), treatment with tranexamic acid (Txa) at a dosage of 750 mg/day resulted in good resolution of hematomas without any complications.

The study suggests that Txa is a safe and effective conservative management option for CSDH in patients who are relatively and mildly symptomatic, as none of the hematomas progressed during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Outcome of Medical Management of Chronic Subdural Hematoma with Tranexamic Acid - A Prospective Observational Study. Kutty, RK., Leela, SK., Sreemathyamma, SB., et al.[2021]

In a randomized controlled trial involving 50 patients with chronic subdural hematoma, the use of tranexamic acid (TXA) post-surgery did not significantly reduce the recurrence rate of hematomas compared to the control group.

The TXA group experienced a higher recurrence rate (8.3%) and had two postoperative complications, suggesting that TXA may not be beneficial and could potentially increase the risk of complications in patients undergoing treatment for chronic subdural hematoma.

NCBI (Pubmed)

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. de Paula, MVCT., Ribeiro, BDC., Melo, MM., et al.[2023]

Tranexamic acid (TXA) significantly reduces the risk of rebleeding and mortality from rebleeding in patients with aneurysmal subarachnoid hemorrhage (aSAH), based on a meta-analysis of 13 studies involving 2991 patients.

Despite its benefits in reducing rebleeding, TXA does not improve overall mortality, neurological outcomes, delayed cerebral ischemia, or hydrocephalus, and no significant adverse events were reported, indicating it is a safe intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tranexamic acid for patients with aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis of 2991 patients. Ghaith, HS., Gabra, MD., Ebada, MA., et al.[2022]

In a study of seven patients with chronic subdural hematoma (cSDH) treated with tranexamic acid (TXA), five patients showed complete resolution of symptoms, suggesting TXA may be an effective conservative treatment for mild cases.

The median hematoma volume decreased by 73% in non-operated patients after TXA treatment, indicating a significant reduction in the size of the hematoma, although one patient required surgery due to worsening symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tranexamic acid for chronic subdural hematoma. Lodewijkx, R., Immenga, S., van den Berg, R., et al.[2022]

The CRASH-3 trial found that tranexamic acid (TXA) significantly reduces mortality in patients with mild to moderate traumatic brain injuries associated with intracranial bleeding.

Despite its promising results, the limitations of the trial prevent TXA from being established as the gold standard treatment for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tranexamic acid and traumatic brain injuries. Sanford, K., Garcia, S.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11070546/

Effectiveness of tranexamic acid on chronic subdural ... TXA can effectively improve the recurrence rate of CDSH. It provides a high level of evidence-based medicine for clinical treatment.

2. thejns.org thejns.org/view/journals/j-neurosurg/141/4/article-p945.xml

Efficacy and safety of tranexamic acid in the management of ... This study evaluated the effectiveness and safety of tranexamic acid (TXA) in treating chronic subdural hematoma, a common brain condition in the elderly.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03582293

Study Details | NCT03582293 | Tranexamic Acid to Prevent ... In five small retrospective series, tranexamic acid (TXA), an antifibrinolytic drug, showed a beneficial effect on the spontaneous resolution of the hematoma ...

4. turkishneurosurgery.org.tr turkishneurosurgery.org.tr/pdf/JTNEPUB_46950_online.pdf

Chronic Subdural Hematoma and Tranexamic Acid The primary outcome assessed was the surgical need for cSDH evacuation within the first 12 weeks of TXA treatment. Of the seven patients, five ( ...

5. ejns.springeropen.com ejns.springeropen.com/articles/10.1186/s41984-024-00332-2

Examining the standalone efficacy and safety of tranexamic ... This meta-analysis suggests tranexamic acid (TXA) may reduce chronic subdural hematoma (CSDH) recurrence, though significance varied across studies.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0735675724001177

Efficacy and safety of tranexamic acid in acute traumatic ... TXA did not elevate the risk of adverse event, however, the lack of reduction in mortality and the poor clinical outcomes constrain the value of clinical ...

7. thieme-connect.com thieme-connect.com/products/ejournals/pdf/10.1055/s-0044-1801771.pdf

Is It Safe to Use Tranexamic Acid for Chronic Subdural ... This study indicated that TXA as an adjunct treatment to BC is a safe option to reduce postoperative hematoma recurrence and reoperation, and ...