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

NCT ID: NCT06696079

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 332 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-07
• Study Completion Date: 2027-06-30

Brief 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.

Conditions

Chronic Subdural Hematoma; Atrial Fibrillation (AF)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Early resumption

Oral anticoagulation therapy is resumed on the 5th postoperative day following burr-hole surgery for chronic subdural hematoma.

Group Type: EXPERIMENTAL

Early Resumption of Oral Anticoagulation Therapy

Intervention Type: 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

Oral anticoagulation therapy is resumed on the 30th postoperative day following burr-hole surgery for chronic subdural hematoma.

Group Type: ACTIVE_COMPARATOR

Late Resumption of Oral Anticoagulation Therapy

Intervention Type: 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.

Interventions

Early Resumption of Oral Anticoagulation Therapy

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.

Intervention Type: DRUG

Late Resumption of Oral Anticoagulation Therapy

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.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tampere University Hospital

OTHER

Sponsor Role: collaborator

Kuopio University Hospital

OTHER

Sponsor Role: collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role: collaborator

Oulu University Hospital

OTHER

Sponsor Role: collaborator

Karolinska University Hospital

OTHER

Sponsor Role: collaborator

Rahul Raj

OTHER

Sponsor Role: lead

Responsible Party

Rahul Raj

Sponsor Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rahul Raj, MD, PhD

Role: STUDY_CHAIR

Helsinki University Hospital & University of Helsinki

Jarno Satopää, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Hospital & University of Helsinki

Jussi P Posti, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital and University of Turku

Teemu Luoto, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital and Tampere University

Nils Danner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kuopio University Hospital and University of Eastern Finland

Oula Knuutinen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oulu University Hospital and University of Oulu

Jiri Bartek, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

Oulu University Hospital

Oulu, North Ostrobothnia, Finland

Site Status: NOT_YET_RECRUITING

Kuopio University Hospital

Kuopio, Northern Savonia, Finland

Site Status: NOT_YET_RECRUITING

Tampere University Hospital

Tampere, Pirkanmaa, Finland

Site Status: NOT_YET_RECRUITING

Turku University Hospital

Turku, Southwest Finland, Finland

Site Status: NOT_YET_RECRUITING

Helsinki University Hospital

Helsinki, Uusimaa, Finland

Site Status: RECRUITING

Karolinska University Hospital

Stockholm, Region Stockholm, Sweden

Site Status: NOT_YET_RECRUITING

Countries

Finland; Sweden

Central Contacts

Rahul Raj, MD, PhD

Role: CONTACT

rahul.raj@hus.fi

+358504272516

Jarno Satopää, MD, PhD

Role: CONTACT

jarno.satopaa@hus.fi

+358504286743‬

Facility Contacts

Oula Knuutinen, MD, PhD

Role: primary

oula.knuutinen@oulu.fi

‭+358405842879‬

Nils Danner, MD, PhD

Role: primary

nils.danner@pshyvinvointialue.fi

‭+358400911568‬

Teemu Luoto, MD, PhD

Role: primary

teemu.luoto@pirha.fi

‭+35840703 9696‬

Jussi P Posti, MD, PhD

Role: primary

jussi.posti@tyks.fi

‭+358443804143‬

Rahul Raj, MD, PhD

Role: primary

rahul.raj@hus.fi

+358504272516

Jarno Satopää, MD, PhD

Role: backup

jarno.satopaa@hus.fi

+358504286743‬

Jiri Bartek, MD, PhD

Role: primary

jiri.bartek@regionstockholm.se

+46707948670‬

Other Identifiers

HUS/7351/2024

Identifier Type: -

Identifier Source: org_study_id