Restarting Early Versus Later Anticoagulation for Chronic Subdural Hematoma With Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRahul Raj
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Early Resumption of Oral Anticoagulation Therapy
- Late Resumption of Oral Anticoagulation Therapy
Treatment groups
332 Participants
are divided into 2 treatment groupsSponsors and collaborators
Rahul Raj
Lead sponsor
Helsinki University Central Hospital
Sponsor institution
Tampere University Hospital
Collaborator
Kuopio University Hospital
Collaborator
Turku University Hospital
Collaborator
Oulu University Hospital
Collaborator
Karolinska University Hospital
Collaborator
Source ClinicalTrials.gov