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

Last updated: August 21, 2025
Sponsor: Rahul Raj
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Chest Pain

Cardiac Disease

Treatment

Late Resumption of Oral Anticoagulation Therapy

Early Resumption of Oral Anticoagulation Therapy

Clinical Study ID

NCT06696079
HUS/7351/2024
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years.

  • Patients with a symptomatic unilateral or bilateral CSDH requiring burr-holeevacuation with drainage (CSDH is predominantly hypodense or isodense on imaging [CT/MRI]; clinical symptoms attributable to the CSDH; patients with bilaterallyoperated CSDHs will be treated with the same protocol on both sides and analyzed asa single study participant).

  • Patients that are on an oral anticoagulation medication due to permanent, persistentor paroxysmal spontaneous atrial fibrillation previously known

  • Randomization done within 4 days of the surgery

Exclusion

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, includingtherapeutical 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 valvesare eligible)

  • Contraindication to anticoagulation medication (for example bleeding disorder,documented high risk of fall [e.g. due to severe alcoholism], severethrombocytopenia, severe anemia)

  • Concomitant use of antiplatelet medication

  • Moderate to severe renal insufficiency (creatinine clearance <30 ml/min or ondialysis)

  • Not a permanent resident in Finland (for Finnish patients) or not a permanentresident in Region Stockholm (for Swedish patients)

Study Design

Total Participants: 332
Treatment Group(s): 2
Primary Treatment: Late Resumption of Oral Anticoagulation Therapy
Phase:
Study Start date:
July 07, 2025
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Oulu University Hospital

    Oulu 643492, North Ostrobothnia 830667 90220
    Finland

    Site Not Available

  • Kuopio University Hospital

    Kuopio 650224, Northern Savonia 830690 70200
    Finland

    Site Not Available

  • Tampere University Hospital

    Tampere, Pirkanmaa 33520
    Finland

    Site Not Available

  • Tampere University Hospital

    Tampere 634963, Pirkanmaa 830704 33520
    Finland

    Site Not Available

  • Oulu University Hospital

    Oulu, Pohjois-Pohjanmaa 90220
    Finland

    Site Not Available

  • Kuopio University Hospital

    Kuopio, Pohjois-Savo 70200
    Finland

    Site Not Available

  • Turku University Hospital

    Turku 633679, Southwest Finland 830708 20520
    Finland

    Site Not Available

  • Helsinki University Hospital

    Helsinki, Uusimaa 00260
    Finland

    Site Not Available

  • Helsinki University Hospital

    Helsinki 658225, Uusimaa 830709 00260
    Finland

    Active - Recruiting

  • Turku University Hospital

    Turku, Varsinais-Suomi 20520
    Finland

    Site Not Available

  • Karolinska University Hospital

    Stockholm, Region Stockholm 17164
    Sweden

    Site Not Available

  • Karolinska University Hospital

    Stockholm 2673730, Region Stockholm 17164
    Sweden

    Site Not Available

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