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

NCT06696079 | Recruiting DMC

• 1 other identifier: HUS/7351/2024
• Study Type: interventional
• Target: 332
• Locations: 2 countries
• Sites: 6

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)

Keywords

chronic subdural hematoma; atrial fibrillation; oral anticoagulation; warfarin; direct oral anticoagulants; surgery; stroke; hemorrhage; prognosis

Outcome Measures

Primary Outcomes (1)

• Rate of composite outcome of vascular events

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

  90 days

Secondary Outcomes (5)

• Rate of different components of the primary composite outcome

  90 days

• Rate of patients with favorable functional outcome

  90 days

• Rate of reoperation

  90 days

• Rate of all-cause mortality

  90 days and 12 months

• Participants' healthcare use

  90 days

Study Arms (2)

Early resumption

EXPERIMENTAL

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

Drug: Early Resumption of Oral Anticoagulation Therapy

Late resumption

ACTIVE COMPARATOR

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

Drug: Late Resumption of Oral Anticoagulation Therapy

Interventions

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.

Early resumption

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.

Late resumption

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rahul Raj: lead
• Tampere University Hospital: collaborator
• Kuopio University Hospital: collaborator
• Turku University Hospital: collaborator
• Oulu University Hospital: collaborator
• Karolinska University Hospital: collaborator

Study Sites (6)

Oulu University Hospital

Oulu, North Ostrobothnia, 90220, Finland

NOT YET RECRUITING

Kuopio University Hospital

Kuopio, Northern Savonia, 70200, Finland

NOT YET RECRUITING

Tampere University Hospital

Tampere, Pirkanmaa, 33520, Finland

NOT YET RECRUITING

Turku University Hospital

Turku, Southwest Finland, 20520, Finland

NOT YET RECRUITING

Helsinki University Hospital

Helsinki, Uusimaa, 00260, Finland

RECRUITING

Karolinska University Hospital

Stockholm, Region Stockholm, 17164, Sweden

NOT YET RECRUITING

MeSH Terms

Conditions

Hematoma, Subdural, Chronic; Atrial Fibrillation; Stroke; Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

• Rahul Raj, MD, PhD

  Helsinki University Hospital & University of Helsinki

  STUDY CHAIR

• Jarno Satopää, MD, PhD

  Helsinki University Hospital & University of Helsinki

  PRINCIPAL INVESTIGATOR

• Jussi P Posti, MD, PhD

  Turku University Hospital and University of Turku

  PRINCIPAL INVESTIGATOR

• Teemu Luoto, MD, PhD

  Tampere University Hospital and Tampere University

  PRINCIPAL INVESTIGATOR

• Nils Danner, MD, PhD

  Kuopio University Hospital and University of Eastern Finland

  PRINCIPAL INVESTIGATOR

• Oula Knuutinen, MD, PhD

  Oulu University Hospital and University of Oulu

  PRINCIPAL INVESTIGATOR

• Jiri Bartek, MD, PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rahul Raj, MD, PhD

CONTACT

+358504272516; rahul.raj@hus.fi

Jarno Satopää, MD, PhD

CONTACT

+358504286743‬; jarno.satopaa@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor masking and blinded data interpretation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Principal Investigator

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 19, 2024
• Study Start: July 7, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 22, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); FI (5)