Atrial Fibrillation (AF), Chronic Subdural Hematoma
Conditions
Keywords
chronic subdural hematoma, atrial fibrillation, oral anticoagulation, warfarin, direct oral anticoagulants, surgery, stroke, hemorrhage, prognosis
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.
Interventions
DRUGEarly 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.
DRUGLate 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
Tampere University Hospital
Kuopio University Hospital
Turku University Hospital
Oulu University Hospital
Karolinska University Hospital
Rahul Raj
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessor masking and blinded data interpretation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of composite outcome of vascular events | 90 days | Rate of the composite outcome that combines thromboembolic events (ischemic stroke, systemic embolism), hemorrhagic events (intracranial hemorrhage, major extracranial bleeding), and vascular death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of different components of the primary composite outcome | 90 days | Separation of the components of the primary composite outcome (thromboembolic, hemorrhagic, vascular death). |
| Rate of patients with favorable functional outcome | 90 days | Assessed using the modified Rankin Scale (mRS), which ranges from 0 (no symptoms) to 6 (death). |
| Rate of reoperation | 90 days | Reoperation for the initially treated chronic subdural hematoma. |
| Rate of all-cause mortality | 90 days and 12 months | — |
| Participants' healthcare use | 90 days | Number and type of unscheduled emergency radiological examinations, - number of emergency department visits, postoperative total hospitalization days |
Countries
Finland, Sweden
Contacts
Primary ContactRahul Raj, MD, PhD
Backup ContactJarno Satopää, MD, PhD
Outcome results
None listed