NCT06696079RecruitingPhase 2/3
Restarting Early Versus Later Anticoagulation for Chronic Subdural Hematoma With Atrial Fibrillation
Restarting Early Versus Later Anticoagulation for Chronic Subdural Hematoma With Atrial Fibrillation (RELACS): An International Multicenter, Randomized Controlled, Two-arm, Assessor-blinded, Trial
Source: ClinicalTrials.gov · Last updated 22 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this randomized clinical trial is to assess the benefit of early resumption versus late resumption of oral anticoagulation medication in adults with atrial fibrillation undergoing surgery for chronic subdural hematoma. The main questions it aims to answer are: * Does anticoagulation resumption 5 days after surgery as compared to 30 days after surgery result in fewer thromboembolic complications, without increasing the risk for bleeding? * Does anticoagulation resumption 5 days after surgery as compared to 30 days after surgery affect the risk of reoperation, functional outcome, mortality, and healthcare use? Researchers will compare early anticoagulation resumption (5 days) and late anticoagulation resumption (30 days) after chronic subdural hematoma surgery. Participants will either resume the medication 5 days or 30 days after the surgery. The participants will be followed up for 3 months after the surgery.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 332 (estimated)
- First submitted
- 18 Nov 2024
- Start date
- 7 Jul 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Rahul Raj
- Diseases
- Stroke, Atrial fibrillation
- NCT number
- NCT06696079
- EU CT number
- 2025-521179-29-00
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 332
- From 7 Jul 2025 to the primary completion date, 31 Dec 2026
- 6 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- CSDH requiring surgical treatment other than burr-hole evacuation (e.g. craniotomy)
- Prior CSDH surgery within 12 months
- Concomitant use of antiplatelet medication
Other illness
- 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)
- Contraindication to anticoagulation medication (for example bleeding disorder, documented high risk of fall \[e.g. due to severe alcoholism\], severe thrombocytopenia, severe anemia)
Lab values
- Moderate to severe renal insufficiency (creatinine clearance \<30 ml/min or on dialysis)
Other
- Intraoperative or immediate postoperative hemorrhagic complication
- Cerebrospinal fluid shunt
- CSDH is in an arachnoid cyst
- If the operated hematoma is revealed to be a cerebrospinal fluid collection (hygroma)
- Not a permanent resident in Finland (for Finnish patients) or not a permanent resident in Region Stockholm (for Swedish patients)
Who the study is looking for
- Age ≥18 years.
- Patients with a symptomatic unilateral or bilateral CSDH requiring burr-hole evacuation with drainage (CSDH is predominantly hypodense or isodense on imaging \[CT/MRI\]; clinical symptoms attributable to the CSDH; patients with bilaterally operated CSDHs will be treated with the same protocol on both sides and analyzed as a single study participant).
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HUS-Yhtymae Coordinator of this site? Confirm its status | Helsinki | Finland | Recruiting |
| Kuopio University Hospital Coordinator of this site? Confirm its status | Kuopio | Finland | Recruiting |
| Oulu University Hospital Coordinator of this site? Confirm its status | Oulu | Finland | Recruiting |
| Tampere University Hospital Coordinator of this site? Confirm its status | Tampere | Finland | Recruiting |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.