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New treatment option for Traumatic Intracranial Haemorrhage
Official title Timing to Restart Direct Oral Anticoagulants After Traumatic Intracranial Haemorrhage
ClinicalTrials.gov ID: NCT06322953
What this study is testing
What is Direct-Acting Oral Anticoagulants (used as per local standard practice)?
Direct-Acting Oral Anticoagulants (used as per local standard practice) is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for traumatic intracranial haemorrhage.
Also referred to as Apixaban, Dabigatran Etexilate Mesilate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Older people falling from a standing height is the most common cause of hospital admission for head injury. Up to 1 in 3 patients admitted are taking a tablet medication which thins the blood, known as an oral anticoagulant.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Informed consent obtained from participant / participants' legal representative and ability to comply with the requirements of the trial
- Adult ≥18 years with traumatic intracranial haemorrhage (tICrH) in the past 1 week who were taking oral anticoagulants (OAC) prior to admission (Oral...
You likely can't join if
- Patients whose traumatic intracranial haemorrhage is a chronic subdural haematoma only
- Patients with a mechanical heart valve
- Patients with a plan to start/restart anti-platelet therapy within 12 weeks of tICrH
- Severe polytrauma or life-threatening injury where there is a contraindication to restarting anticoagulation
- Pregnant or nursing female
- For participants of reproductive potential (males and females), not willing to use of a reliable means of contraception
See the full eligibility criteria
- Informed consent obtained from participant / participants' legal representative and ability to comply with the requirements of the trial
- Adult ≥18 years with traumatic intracranial haemorrhage (tICrH) in the past 1 week who were taking oral anticoagulants (OAC) prior to admission (Oral anticoagulants include any DOAC or Vitamin K antagonist (e.g...
- Patients whose traumatic intracranial haemorrhage is a chronic subdural haematoma only
- Patients with a mechanical heart valve
- Patients with a plan to start/restart anti-platelet therapy within 12 weeks of tICrH
- Severe polytrauma or life-threatening injury where there is a contraindication to restarting anticoagulation
- Pregnant or nursing female
- For participants of reproductive potential (males and females), not willing to use of a reliable means of contraception
- Participants with a hypersensitivity or contraindication to Direct Oral Anticoagulant (DOAC) as detailed in each IMP SmPC
- Participant with bleeding where it would be unsafe to restart DOAC at 1 week
- Participant with clinical reason to restart DOAC before 4 weeks or complete within 12 weeks
- Indication to stay on VKA (Warfarin) rather than switching to DOAC (e.g. severe renal impairment)
The study team makes the final eligibility decision.
Where it's taking place
- Plymouth, Devon, United Kingdom
- Liverpool, Mersyside, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Plymouth, Devon, United Kingdom; Liverpool, Mersyside, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.