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Restarting Early versus Later Anticoagulation for Chronic Subdural Hematoma with Atrial Fibrillation (RELACS)
EU CTIS ID: 2025-521179-29-00
What this study is testing
The primary objective of the RELACS trial is to estimate the net effect of early resumption versus late resumption of oral anticoagulation medication in patients with AF undergoing surgery for CSDH. Net effect is estimated by a composite outcome that combines thromboembolic events (ischemic stroke, systemic embolism), hemorrhagic events (intracranial hemorrhage, major extracranial bleeding) and vascular death.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥18 years
- Patients with a symptomatic unilateral or bilateral CSDH requiring burr-hole evacuation
- Patients that are on an oral anticoagulation medication due to permanent, persistent or paroxysmal spontaneous atrial fibrillation previously known
- Randomization done within 4 days of the surgery
- Patients with cognitive impairment, including mild cognitive impairment or dementia, are eligible if a legally authorized representative can provide informed consent on their behalf, as detailed in the informed consent section
- Patients on standard or reduced doses of oral anticoagulants for stroke prevention in atrial fibrillation are eligible. Reduced doses must be in accordance with approved dosing recommendations and clinical practice guidelines based on patient-specific factors such as renal function, age, and body weight.
You likely can't join if
- Intraoperative or immediate postoperative hemorrhagic complication
- If the operated hematoma reveals to be a cerebrospinal fluid collection (hygroma)
- Conditions other than atrial fibrillation that require anticoagulation, including therapeutical dose of low molecular-weight heparin or heparin (for example, pulmonary embolism, deep vein thrombosis, hypercoagulability syndromes)
- Mechanical heart valve(s)
- Moderate or severe mitral stenosis (other valvular diseases and biological valves are eligible)
- Women of childbearing potential
See the full eligibility criteria
- Age ≥18 years
- Patients with a symptomatic unilateral or bilateral CSDH requiring burr-hole evacuation
- Patients that are on an oral anticoagulation medication due to permanent, persistent or paroxysmal spontaneous atrial fibrillation previously known
- Randomization done within 4 days of the surgery
- Patients with cognitive impairment, including mild cognitive impairment or dementia, are eligible if a legally authorized representative can provide informed consent on their behalf, as detailed in the informed consent section
- Patients on standard or reduced doses of oral anticoagulants for stroke prevention in atrial fibrillation are eligible. Reduced doses must be in accordance with approved dosing recommendations and clinical practice guidelines based on patient-specific factors such as renal function, age, and body weight.
- Intraoperative or immediate postoperative hemorrhagic complication
- If the operated hematoma reveals to be a cerebrospinal fluid collection (hygroma)
- Conditions other than atrial fibrillation that require anticoagulation, including therapeutical dose of low molecular-weight heparin or heparin (for example, pulmonary embolism, deep vein thrombosis, hypercoagulability syndromes)
- Mechanical heart valve(s)
- Moderate or severe mitral stenosis (other valvular diseases and biological valves are eligible)
- Women of childbearing potential
- Contraindication to anticoagulation medication (for example bleeding disorder, documented high risk of fall [e.g. due to severe alcoholism], severe thrombocytopenia, severe anemia)
- Concomitant use of antiplatelet medication
- Moderate to severe renal insufficiency (creatinine clearance <30 ml/min or on dialysis)
- Not a permanent resident in Finland (for Finnish patients) or not a permanent resident in Region Stockholm (Swedish patients)
- CSDH requiring surgical treatment other than burr-hole evacuation (e.g. craniotomy)
- Prior CSDH surgery within 12 months
- Cerebrospinal fluid shunt
- CSDH is in an arachnoid cyst
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.