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A Study on the Safety of Tranexamic Acid for the Chronic Subdural Hematoma Population
Phase 4 trial testing Tranexamic Acid in Subdural Hematoma in 32 participants. Completed in 12 June 2018.
| Lead sponsor | St. Joseph's Hospital and Medical Center, Phoenix |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 1 November 2015 |
| Primary completion | 1 August 2017 |
| Estimated completion | 12 June 2018 |
| Sites | 1 location across United States |
St. Joseph's Hospital and Medical Center, Phoenix
Adults 18 to 85, any sex, with Subdural Hematoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
occurrence of stroke, myocardial infarction, deep vein thrombosis, and/or pulmonary embolism within 30 days
| Group | Value | 95% CI |
|---|---|---|
| All Subjects | 0 |
Hematoma width (measured in cm) on post operative CT scans compared to baseline (preoperative). Preoperative axial non-contrast CT images were reviewed by a study investigator for maximal hematoma thickness, the presence of septations, and midline shift. Septations were determined to be present if there were thin, hyperdense, dividing membranes within the limits of the subdural collection. Postoperative axial non-contrast CT was planned within 24 hours post surgery and on postoperative days 3 and 30 (which could be scheduled within 7 days of the 30-day mark) to determine maximal hematoma thick
| Group | Value | 95% CI |
|---|---|---|
| All Subjects | 2.24 | ± 0.65 |
| Group | Value | 95% CI |
|---|---|---|
| All Subjects | 1.17 | ± 0.53 |
| Group | Value | 95% CI |
|---|---|---|
| All Subjects | 1.28 | ± 0.55 |
| Group | Value | 95% CI |
|---|---|---|
| All Subjects | 0.73 | ± 0.73 |
The Modified Rankin Score (mRS) is a 6 point disability scale with scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire. Lower score of 0, 1,2 are the best outcome up to 5 with worst outcome. 0 The patient has no residual symptoms. 1. The patient has no significant disability; able to resume all pre-stroke activities. 2. The patient has slight disability; unable to resume all pre-stroke activities but able to look after self without daily help. 3. The patient has moderate disability; requiring some external help but able to walk without the assistance
| Group | Value | 95% CI |
|---|---|---|
| All Subjects | 2.3 | ± 1.3 |
| Group | Value | 95% CI |
|---|---|---|
| All Subjects | 0.9 | ± 1.1 |
National Institute of Health Stroke Scale (NIHSS) (0-42); 0 is better, 42 is worse. The NIHSS measures several aspects of brain function, including consciousness, vision, sensation, movement, speech, and language. A certain number of points are given for each of these physical and cognitive functions during a focused neurological examination. A maximum score of 42 represents the most severe and devastating stroke. The levels of stroke severity as measured by the NIHSS scoring system are: 0 = no stroke 1-4 = minor stroke 5-15 = moderate stroke 15-20 = moderate/severe stroke 21-42 = severe st
| Group | Value | 95% CI |
|---|---|---|
| All Subjects | 1.7 | ± 1.5 |
| Group | Value | 95% CI |
|---|---|---|
| All Subjects | 0.2 | ± 0.4 |
Time frame: at 30 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | All Subjects |
|---|---|---|
| Wound infection | Infections and infestations | — |
| Alcohol withdrawal syndrome | Psychiatric disorders | — |
| Epidural hemorrhage | Vascular disorders | — |
| seizure | Nervous system disorders | — |
| Reaction | System | All Subjects |
|---|---|---|
| hyponatremia | Metabolism and nutrition disorders | — |
| Urinary Tract Infection | Renal and urinary disorders | — |
| Depressed level of consciousness | Nervous system disorders | — |
Most-reported serious reactions: Wound infection, Alcohol withdrawal syndrome, Epidural hemorrhage, seizure.
Data from ClinicalTrials.gov NCT02618382 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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