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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Early Resumption of Oral Anticoagulation Therapy
DrugThe 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 of Oral Anticoagulation Therapy
DrugThe 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.
Treatment groups
332 Participants
are divided into 2 treatment groupsGroup A: Early resumptionExperimental treatment 1 intervention
Group B: Late resumptionActive comparator 1 intervention
Trial outcomes
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.
Time frame
90 daysSecondary outcomes
1
Rate of different components of the primary composite outcome
Separation of the components of the primary composite outcome (thromboembolic, hemorrhagic, vascular death).
Time frame
90 days2
Rate of patients with favorable functional outcome
Assessed using the modified Rankin Scale (mRS), which ranges from 0 (no symptoms) to 6 (death).
Time frame
90 days3
Rate of reoperation
Reoperation for the initially treated chronic subdural hematoma.
Time frame
90 days4
Rate of all-cause mortality
Time frame
90 days and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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