Phase 4
N=32
A Study on the Safety of Tranexamic Acid for the Chronic Subdural Hematoma Population
Subdural Hematoma
Bottom Line
View on ClinicalTrials.gov: NCT02618382 ↗Enrolled (actual)
32
Serious AEs
21.9%
Results posted
Nov 2021
Primary outcome: Primary: Number of Participants With Medication Related (Thromboembolic) Complications — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tranexamic Acid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Medication Related (Thromboembolic) Complications |
— | — |
| SECONDARY Hematoma Thickness on CT Scan |
2.24; 1.17; 1.28; 0.73 | <0.05 sig |
| SECONDARY Functional Status Determined by Modified Rankin Score (mRS) From Baseline to 30 Days Postop |
2.3; 0.9 | <0.05 sig |
| SECONDARY Change in National Institute of Health Stroke Scale (NIHSS) |
1.7; 0.2 | <0.05 sig |
Summary
This is a single center single arm study of 50 patients to 1) determine the safety of tranexamic acid in the chronic subdural hematoma population following surgical drainage of chronic subdural hematomas and 2) determine if the use of oral tranexamic acid reduces the rate of ipsilateral recurrence following drainage of chronic subdural hematomas. This will be compared to historical controls. This study intends to be a prerequisite to a large nationally funded randomized control trial.
Eligibility Criteria
Inclusion Criteria
- all patients undergoing intervention for chronic subdural hematoma (cSDH) including drainage
- cSDH will be defined as hematoma on CT imaging that is predominantly iso- to hypodense to brain
- 18-85 years of age
Exclusion Criteria
- cSDH not requiring surgical drainage
- patients undergoing bedside twist drill craniostomy
- medically unstable for surgery
- patients requiring long-term anticoagulation (unable to stay off for less than 30 days)
- patients not expected to survive to the completion of followup
- patients comatose prior to the initiation of treatment
- history of thromboembolic problem including stroke, myocardial infarction, deep vein thrombosis and/or pulmonary embolism
- pregnant
- minor
- allergy/sensitivity to tranexamic acid
- irreversible coagulopathy
- known clotting disorder
- bilateral hematomas with both requiring drainage
- incarcerated
- any patient not judged suitable for the study by the investigators
- women who are taking combination hormonal contraception
Data sourced from ClinicalTrials.gov (NCT02618382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.