Timing to Restart Blood Thinners After Brain Bleeding

A Randomised Trial of Timing to Restart Direct Oral Anticoagulants After Traumatic Intracranial Haemorrhage

This study is testing the best time to restart blood thinners in older adults who have had a brain bleed to see how to keep them safe from both bleeding and blood clots.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 1084 (estimated)
• Sex: All
• Sponsor: Walton Centre NHS Foundation Trust (other)
• Locations: 2 sites (Plymouth, Devon and 1 other locations)
• Trial ID: NCT06322953 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the optimal timing for restarting direct oral anticoagulants (DOACs) in older patients who have experienced traumatic intracranial hemorrhage (tICrH). The study aims to balance the risks of worsening bleeding in the brain against the potential for thromboembolic complications, such as stroke. Participants will be adults aged 18 and older who were on anticoagulant therapy prior to their injury and are at high risk for thromboembolic events. The trial will follow a randomized approach to determine the safest time frame for resuming anticoagulant therapy after a head injury.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a recent traumatic intracranial hemorrhage who were taking oral anticoagulants prior to their injury.

Not a fit: Patients with chronic subdural hematomas, mechanical heart valves, or those planning to start anti-platelet therapy within 12 weeks of their injury may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide critical guidance on the safe timing for restarting anticoagulant therapy, potentially reducing the risk of strokes and blood clots in older patients.

How similar studies have performed: While there is limited clear evidence on the timing for restarting anticoagulants after tICrH, similar studies have explored anticoagulant management in other contexts, indicating a need for this investigation.

Eligibility criteria

Inclusion Criteria:

1. Informed consent obtained from participant / participants' legal representative / participants' Consultee and ability to comply with the requirements of the trial
2. Adult ≥18 years with traumatic intracranial haemorrhage (tICrH) in the past 1 week who were taking oral anticoagulants (OAC) prior to admission
3. Oral anticoagulants include any DOAC or Vitamin K antagonist (VKA) (e.g. Warfarin), prescribed for atrial fibrillation (AF) or venous thromboembolism (VTE) prior to admission for tICrH
4. At high risk for thromboembolic complications (CHA2DS2VASc ≥2 in men and ≥3 in women)

Exclusion Criteria:

1. Patients whose traumatic intracranial haemorrhage is a chronic subdural haematoma
2. Patients with mechanical heart valve
3. Patients with plan to start/restart anti-platelet therapy within 12 weeks of tICrH
4. Abbreviated Injury Scale other than head with a score \>3
5. Pregnancy
6. Participants with a hypersensitivity or contraindication to Direct Oral Anticoagulant (DOAC)
7. Participant with bleeding where it would be unsafe to restart DOAC at 1 week
8. Participant with clinical reason to restart DOAC before 4 weeks or complete within 12 weeks
9. Concomitant p-gp and CYP3A4 inducers/inhibitors
10. Indication to stay on VKA (Warfarin) rather than switching to DOAC (e.g. severe renal impairment)

Where this trial is running

Plymouth, Devon and 1 other locations

• University Hospitals Plymouth NHS Trust — Plymouth, Devon, United Kingdom (RECRUITING)
• The Walton Centre NHS Foundation Trust — Liverpool, Mersyside, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Catherine McMahon — Northern Care Alliance NHS Foundation Trust
• Study coordinator: Laura Wright

Conditions: Traumatic Intracranial Haemorrhage, Direct Oral Anticoagulants, Randomised Trial