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NCT Number: NCT06696079

Restarting Early Versus Later Anticoagulation for Chronic Subdural Hematoma With Atrial Fibrillation

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.

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Key information

Conditions

Chronic Subdural Hematoma Arrhythmias, Cardiac Atrial Fibrillation Atrial Fibrillation (AF) Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Disease Craniocerebral Trauma Disease Attributes Heart Diseases Hematoma Hematoma, Subdural Hematoma, Subdural, Chronic Hemorrhage Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oulu University Hospital, Oulu, North Ostrobothnia, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Intraoperative or immediate postoperative hemorrhagic complication
  • 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
  • If the operated hematoma is revealed 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)
  • 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 (for Swedish patients)

Treatment and study plan

Early Resumption of Oral Anticoagulation Therapy

Drug

The patient's prescribed anticoagulant therapy for atrial fibrillation is resumed on the 5th postoperative day following burr-hole surgery for chronic subdural hematoma. This early resumption strategy is compared to the standard practice of resuming anticoagulation therapy on the 30th postoperative day.

Late Resumption of Oral Anticoagulation Therapy

Drug

The patient's prescribed anticoagulant therapy for atrial fibrillation is resumed on the 30th postoperative day following burr-hole surgery for chronic subdural hematoma. This standard resumption strategy is compared to the early approach of resuming anticoagulation therapy on the 5th postoperative day.

Primary outcomes

  1. Rate of composite outcome of vascular events

    Time frame: 90 days

    Rate of the composite outcome that combines thromboembolic events (ischemic stroke, systemic embolism), hemorrhagic events (intracranial hemorrhage, major extracranial bleeding), and vascular death.

Secondary outcomes

  1. Rate of different components of the primary composite outcome

    Time frame: 90 days

    Separation of the components of the primary composite outcome (thromboembolic, hemorrhagic, vascular death).

  2. Rate of patients with favorable functional outcome

    Time frame: 90 days

    Assessed using the modified Rankin Scale (mRS), which ranges from 0 (no symptoms) to 6 (death).

  3. Rate of reoperation

    Time frame: 90 days

    Reoperation for the initially treated chronic subdural hematoma.

  4. Rate of all-cause mortality

    Time frame: 90 days and 12 months

  5. Participants' healthcare use

    Time frame: 90 days

    Number and type of unscheduled emergency radiological examinations, - number of emergency department visits, postoperative total hospitalization days

Study contacts

Contact information is provided by the study sponsor or research team.

Jarno Satopää, MD, PhD

CONTACT

[email protected]

+358504286743‬

Rahul Raj, MD, PhD

CONTACT

[email protected]

+358504272516

Sponsors and collaborators

Lead sponsor

Rahul Raj

Other

Collaborators

  • Karolinska University Hospital
  • Kuopio University Hospital
  • Oulu University Hospital
  • Tampere University Hospital
  • Turku University Hospital

Registry information

Official study title

Restarting Early Versus Later Anticoagulation for Chronic Subdural Hematoma With Atrial Fibrillation (RELACS): An International Multicenter, Randomized Controlled, Two-arm, Assessor-blinded, Trial

Acronym: RELACS

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 19, 2024
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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