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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
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

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
HUS-Yhtymae
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HelsinkiFinlandRecruiting
Kuopio University Hospital
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KuopioFinlandRecruiting
Oulu University Hospital
Coordinator of this site? Confirm its status
OuluFinlandRecruiting
Tampere University Hospital
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TampereFinlandRecruiting
Turku University Hospital
Coordinator of this site? Confirm its status
TurkuFinlandRecruiting
Karolinska University Hospital
Coordinator of this site? Confirm its status
SolnaSwedenRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.