Adverse events

The use of the trial’s regimen was not associated with any complication in the only available study [16]. Other, higher-dose TXA regimens have been proven safe and effective for other indications [22, 23]. However, our study population will likely be older than these earlier studies and TRACS will specifically assess TXA safety in the CSDH population. As such, adverse events will be systematically monitored during hospital stay and at each follow-up. Any event thought by the treating physician to be potentially related to TXA will be reported within 48 h of detection using a standardized Adverse Event Report Form. Adverse events to be specifically assessed at each follow-up include the incidence of deep venous thrombosis, pulmonary embolism, transient ischemic attacks, stroke, pseudo-nephrolithiasis and subjective changes in vision. Any other side effects reported by patients will also be documented. Adverse Event Reports will be screened by each site’s principal investigator as soon as they are produced. An independent safety monitoring committee will review all Adverse Event Reports, and analyze the rates of TXA adverse events after follow-up data is available for the 65th subject. As part of the interim analysis, the safety monitoring committee will produce a report to be reviewed by the trial steering committee and might request a trial review by the IRB should any concern arise. Group allocation unblinding will be performed if a highly statistically significant (p <0.001) difference in the rate of adverse events is identified.

Adverse events will be reported using the classification of the Medical Dictionary for Regulatory Activities, version 19.0.