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

NCT02618382 | Completed Phase 4 Results DMC

• 1 other identifier: PHX15BN048
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Subdural Hematoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Medication Related (Thromboembolic) Complications

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

  30 days

Secondary Outcomes (3)

• Hematoma Thickness on CT Scan

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

• Functional Status Determined by Modified Rankin Score (mRS) From Baseline to 30 Days Postop

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

• Change in National Institute of Health Stroke Scale (NIHSS)

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

Study Arms (1)

All subjects

EXPERIMENTAL

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.

Drug: Tranexamic Acid

Interventions

Tranexamic Acid DRUG

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

Also known as: Lysteda, Cyklokapron

All subjects

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead
• Barrow Neurological Foundation: collaborator

Study Sites (1)

Barrow Brain and Spine

Phoenix, Arizona, 85013, United States

Location

MeSH Terms

Conditions

Hematoma, Subdural

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Hematoma; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Limitations and Caveats

This study limitations include its small size, lack of a control group, and deviations in study protocol with regard to postoperative imaging. Given that the study was not designed to determine the relative effectiveness of TXA in preventing recurrence, factors that may have influenced the recurrence rate, such as hematoma size, hematoma characteristics, and surgical technique, were unable to be controlled.

Results Point of Contact

• Title: Lisa Arnold, Clinical Research Operations Manager
• Organization: Dignity Health Research Institute

lisa.arnold@arrowneuro.org

602-406-9593

Study Officials

• Andrew S Little, MD

  Barrow Brain and Spine, Phoenix, AZ

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research manager

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 1, 2015
• Study Start: November 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: June 12, 2018
• Last Updated: November 11, 2021
• Results First Posted: November 9, 2021

Record last verified: 2021-11

Locations

US (1)