Health TrialsbyHealthPanel

Tranexamic Acid Therapy For The Treatment of Subdural Hematomas

ConditionChronic Subdural Hematoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-95
SponsorBaylor College of Medicine

About this trial

This Phase II randomized, placebo-controlled, double-blinded trial is the first step in our endeavor to improve the clinical outcomes of patients with chronic subdural hematomas (cSDH). Patients who are deemed to not need surgery for their cSDH will be randomly assigned to either the treatment group or the placebo group. Both groups will take a 650mg tablet once daily for 21 weeks and follow the standard of care monitoring for cSDH which is neurological testing and imaging at 6 weeks, 12 weeks, and 21 weeks. With this study, we hope to establish the safety and efficacy of using TXA PO to resolve cSDH without the need for surgical intervention.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

CT scan demonstrating existence of a subdural hematoma, unilateral or bilateral, containing a chronic component

Neurosurgeon evaluation deemed patient to not need surgery

Diagnosis within the last 14 days

Signed informed consent

Disqualifiers

Planned surgery, burr-hole craniostomy or mini-craniotomy for their chronic subdural hematoma based on one or more of the following symptoms: medically intractable headache, midline shift >5mm, SDH thickness >10mm, increased ICP, imminent death within 24 hours

Structural causes for subdural hemorrhage (arachnoid cysts, cortical vascular malformations)

Recent ischemic stroke

Other concomitant intracranial pathology (intracranial malignancy)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tranexamic Acid 650 MG

    Drug

    PO administration of TXA tablet

  • Placebo

    Drug

    PO administration of placebo tablet

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: PO 650mg TXA tabletExperimental treatment 1 intervention
Group B: PO 650mg placebo tabletPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of resolution measured as the cSDH volume or diameter

Time frame
6 weeks, 12 weeks, 21 weeks

Secondary outcomes

1

cSDH volume (measured as volume or diameter on follow-up CT scan of the head)

Time frame
6 weeks, 12 weeks, 21 weeks
2

Proportion of patients needing surgery

Time frame
12 weeks, 12 weeks, 21 weeks
3

Hematoma recurrence Hematoma recurrence

Time frame
12 weeks, 12 weeks, 21 weeks
4

Neurological outcome assessed by NIHSS

Time frame
6 weeks, 12 weeks, 21 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baylor College of Medicine

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: