Early versus later restart of blood thinners after surgery for chronic subdural hematoma in people with atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial assigns adults with atrial fibrillation who undergo burr-hole evacuation for symptomatic chronic subdural hematoma to resume their oral anticoagulant either 5 days or 30 days after surgery. Participants are followed for three months to record thromboembolic events, bleeding complications, need for reoperation, functional outcomes, mortality, and healthcare use. The study uses standard clinical management apart from the timing of anticoagulation resumption and analyzes outcomes between the two groups. Results aim to clarify whether earlier anticoagulation reduces clot-related events without increasing harm.

Why it matters

Who can join: the full rules

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)

Where it's running

• Helsinki University Hospital
  Helsinki, Uusimaa, Finland Recruiting
• Oulu University Hospital
  Oulu, North Ostrobothnia, Finland Not yet recruiting
• Kuopio University Hospital
  Kuopio, Northern Savonia, Finland Not yet recruiting
• Tampere University Hospital
  Tampere, Pirkanmaa, Finland Not yet recruiting
• Turku University Hospital
  Turku, Southwest Finland, Finland Not yet recruiting
• Karolinska University Hospital
  Stockholm, Region Stockholm, Sweden Not yet recruiting

Study contacts

• Principal investigator: Jarno Satopää, MD, PhD — Helsinki University Hospital & University of Helsinki
• Study coordinator: Rahul Raj, MD, PhD
• Email: rahul.raj@hus.fi
• Phone: +358504272516

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.