Trial Outcomes & Findings for A Study on the Safety of Tranexamic Acid for the Chronic Subdural Hematoma Population (NCT NCT02618382)

NCT ID: NCT02618382

Last Updated: 2021-11-11

Results Overview

occurrence of stroke, myocardial infarction, deep vein thrombosis, and/or pulmonary embolism within 30 days

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 32 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2021-11-11

Participant Flow

Participants were recruited from a single major neurological center from Nov 2015 to Aug 2017. Patients between the ages 18 and 85 undergoing operative treatment with postop drainage of chronic SDH were evaluated for inclusion. Participants received a single dose of tranexamic acid 1300 mg preop and then 3 times daily for 3 days postop or until dc

Participant milestones

Measure	All Subjects Patients will undergo standard treatment of their chronic subdural hematoma with the addition of preoperative and postoperative oral tranexamic acid treatment. Patients will receive a dose of 1300mg orally three to four hours prior to surgery. They will then take 1300mg orally three times daily for three days or until discharge, whichever occurs first. Tranexamic Acid: 1300mg tranexamic acid by mouth once before surgery and then three times a day for up to three days or until they are discharged from the hospital, whichever comes first
Overall Study STARTED	32
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	All Subjects Patients will undergo standard treatment of their chronic subdural hematoma with the addition of preoperative and postoperative oral tranexamic acid treatment. Patients will receive a dose of 1300mg orally three to four hours prior to surgery. They will then take 1300mg orally three times daily for three days or until discharge, whichever occurs first. Tranexamic Acid: 1300mg tranexamic acid by mouth once before surgery and then three times a day for up to three days or until they are discharged from the hospital, whichever comes first
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	1
Overall Study Protocol Violation	1

Baseline Characteristics

A Study on the Safety of Tranexamic Acid for the Chronic Subdural Hematoma Population

Baseline characteristics by cohort

Measure	All Subjects n=32 Participants Patients will undergo standard treatment of their chronic subdural hematoma with the addition of preoperative and postoperative oral tranexamic acid treatment. Patients will receive a dose of 1300mg orally three to four hours prior to surgery. They will then take 1300mg orally three times daily for three days or until discharge, whichever occurs first. Tranexamic Acid: 1300mg tranexamic acid by mouth once before surgery and then three times a day for up to three days or until they are discharged from the hospital, whichever comes first
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants
Age, Continuous	66 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	06 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

occurrence of stroke, myocardial infarction, deep vein thrombosis, and/or pulmonary embolism within 30 days

Outcome measures

Measure

All Subjects n=32 Participants Patients will undergo standard treatment of their chronic subdural hematoma with the addition of preoperative and postoperative oral tranexamic acid treatment. Patients will receive a dose of 1300mg orally three to four hours prior to surgery. They will then take 1300mg orally three times daily for three days or until discharge, whichever occurs first. Tranexamic Acid: 1300mg tranexamic acid by mouth once before surgery and then three times a day for up to three days or until they are discharged from the hospital, whichever comes first

Number of Participants With Medication Related (Thromboembolic) Complications

0 Participants

SECONDARY outcome

Timeframe: postoperative days 1, 3, and 30+/-7 days

Population: 1 participant did not receive 3-day post-operative follow-up CT because they were discharged home prior to day 3. 8 participants did not receive 30-day postoperative follow-up CT: in 5 of these patients, postoperative imaging was deemed unnecessary by the treating provider because of the patients' clinical progress. In the other 3 patients, follow-up imaging was obtained with magnetic resonance imaging rather than CT, as dictated by the treating surgeon

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 thickness and midline shift using the preoperative methodology.

Outcome measures

Measure	All Subjects n=32 Participants Patients will undergo standard treatment of their chronic subdural hematoma with the addition of preoperative and postoperative oral tranexamic acid treatment. Patients will receive a dose of 1300mg orally three to four hours prior to surgery. They will then take 1300mg orally three times daily for three days or until discharge, whichever occurs first. Tranexamic Acid: 1300mg tranexamic acid by mouth once before surgery and then three times a day for up to three days or until they are discharged from the hospital, whichever comes first
Hematoma Thickness on CT Scan Preop (Baseline) hematoma thickness	2.24 centimeters Standard Deviation 0.65
Hematoma Thickness on CT Scan Postop day 1 - hematoma thickness	1.17 centimeters Standard Deviation 0.53
Hematoma Thickness on CT Scan Postop day 3 - hematoma thickness	1.28 centimeters Standard Deviation 0.55
Hematoma Thickness on CT Scan Postop day 30 - hematoma hematoma thickness	0.73 centimeters Standard Deviation 0.73

SECONDARY outcome

Timeframe: Measured between 2 timepoints: Baseline(Day 0) and postoperative (day 30)

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 of another individual.

4. The patient has moderately severe disability; unable to walk or attend to bodily functions without assistance.

5. The patient has severe disability; bedridden, incontinent, requires continuous care.

6. The patient has expired (during the hospital stay or after discharge from the hospital).

A chi -squared test was used for categorical value

Outcome measures

Measure	All Subjects n=32 Participants Patients will undergo standard treatment of their chronic subdural hematoma with the addition of preoperative and postoperative oral tranexamic acid treatment. Patients will receive a dose of 1300mg orally three to four hours prior to surgery. They will then take 1300mg orally three times daily for three days or until discharge, whichever occurs first. Tranexamic Acid: 1300mg tranexamic acid by mouth once before surgery and then three times a day for up to three days or until they are discharged from the hospital, whichever comes first
Functional Status Determined by Modified Rankin Score (mRS) From Baseline to 30 Days Postop Baseline mRS Score	2.3 score on a scale Standard Deviation 1.3
Functional Status Determined by Modified Rankin Score (mRS) From Baseline to 30 Days Postop Postop Day 30 mRS score	0.9 score on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: Immediately preoperative (Day 0) and discharge (up to 30 days postoperative)

Population: NIHSS Assessment was not done at postoperative day 30 secondary to non in person visit. Other assessments for these 4 participants were done via telephone.

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 stroke

Outcome measures

Measure	All Subjects n=32 Participants Patients will undergo standard treatment of their chronic subdural hematoma with the addition of preoperative and postoperative oral tranexamic acid treatment. Patients will receive a dose of 1300mg orally three to four hours prior to surgery. They will then take 1300mg orally three times daily for three days or until discharge, whichever occurs first. Tranexamic Acid: 1300mg tranexamic acid by mouth once before surgery and then three times a day for up to three days or until they are discharged from the hospital, whichever comes first
Change in National Institute of Health Stroke Scale (NIHSS) Preop (baseline) NIHSS Score	1.7 score on a scale Standard Deviation 1.5
Change in National Institute of Health Stroke Scale (NIHSS) Postop day 30 NIHSS Score	0.2 score on a scale Standard Deviation 0.4

Adverse Events

All Subjects

Serious events: 7 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Subjects n=32 participants at risk Patients will undergo standard treatment of their chronic subdural hematoma with the addition of preoperative and postoperative oral tranexamic acid treatment. Patients will receive a dose of 1300mg orally three to four hours prior to surgery. They will then take 1300mg orally three times daily for three days or until discharge, whichever occurs first. Tranexamic Acid: 1300mg tranexamic acid by mouth once before surgery and then three times a day for up to three days or until they are discharged from the hospital, whichever comes first
Infections and infestations Wound infection	9.4% 3/32 • Number of events 3 • at 30 days
Psychiatric disorders Alcohol withdrawal syndrome	6.2% 2/32 • Number of events 2 • at 30 days
Vascular disorders Epidural hemorrhage	3.1% 1/32 • Number of events 1 • at 30 days
Nervous system disorders seizure	3.1% 1/32 • Number of events 1 • at 30 days

Other adverse events

Measure	All Subjects n=32 participants at risk Patients will undergo standard treatment of their chronic subdural hematoma with the addition of preoperative and postoperative oral tranexamic acid treatment. Patients will receive a dose of 1300mg orally three to four hours prior to surgery. They will then take 1300mg orally three times daily for three days or until discharge, whichever occurs first. Tranexamic Acid: 1300mg tranexamic acid by mouth once before surgery and then three times a day for up to three days or until they are discharged from the hospital, whichever comes first
Renal and urinary disorders Urinary Tract Infection	3.1% 1/32 • Number of events 1 • at 30 days
Nervous system disorders Depressed level of consciousness	3.1% 1/32 • Number of events 1 • at 30 days
Metabolism and nutrition disorders hyponatremia	15.6% 5/32 • Number of events 5 • at 30 days

Additional Information

Lisa Arnold, Clinical Research Operations Manager

Dignity Health Research Institute

Phone: 602-406-9593

Email: lisa.arnold@arrowneuro.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place