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

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)

Interventions

DRUG

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.

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.

Sponsors & Collaborators

• Tampere University Hospital

  collaborator OTHER

• Kuopio University Hospital

  collaborator OTHER

• Turku University Hospital

  collaborator OTHER_GOV

• Oulu University Hospital

  collaborator OTHER

• Karolinska University Hospital

  collaborator OTHER

• Rahul Raj

  lead OTHER

Principal Investigators

• Rahul Raj, MD, PhD · Helsinki University Hospital & University of Helsinki

• Jarno Satopää, MD, PhD · Helsinki University Hospital & University of Helsinki

• Jussi P Posti, MD, PhD · Turku University Hospital and University of Turku

• Teemu Luoto, MD, PhD · Tampere University Hospital and Tampere University

• Nils Danner, MD, PhD · Kuopio University Hospital and University of Eastern Finland

• Oula Knuutinen, MD, PhD · Oulu University Hospital and University of Oulu

• Jiri Bartek, MD, PhD · Karolinska University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-07

Primary Completion

2026-12-31

Completion

2027-06-30

Countries

• Finland
• Sweden

Study Locations