Actively Recruiting
Restarting Early Versus Later Anticoagulation for Chronic Subdural Hematoma With Atrial Fibrillation
Led by Rahul Raj · Updated on 2025-08-22
332
Participants Needed
6
Research Sites
99 weeks
Total Duration
On this page
Sponsors
R
Rahul Raj
Lead Sponsor
T
Tampere University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Restarting Early Versus Later Anticoagulation for Chronic Subdural Hematoma With Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Symptomatic unilateral or bilateral chronic subdural hematoma requiring burr-hole evacuation with drainage
- Chronic subdural hematoma is mainly hypodense or isodense on CT or MRI imaging
- Clinical symptoms are attributable to the chronic subdural hematoma
- Patients on oral anticoagulation medication for permanent, persistent, or paroxysmal spontaneous atrial fibrillation
- Randomization performed within 4 days after surgery
You will not qualify if you...
- Intraoperative or immediate postoperative bleeding complications
- Chronic subdural hematoma requiring surgical treatment other than burr-hole evacuation, such as craniotomy
- Prior chronic subdural hematoma surgery within the past 12 months
- Presence of cerebrospinal fluid shunt
- Chronic subdural hematoma located in an arachnoid cyst
- Operated hematoma found to be cerebrospinal fluid collection (hygroma)
- Conditions other than atrial fibrillation requiring anticoagulation, including therapeutic doses of low molecular-weight heparin or heparin (e.g., pulmonary embolism, deep vein thrombosis, hypercoagulability syndromes)
- Mechanical heart valves
- Moderate or severe mitral stenosis (other valvular diseases and biological valves are allowed)
- Contraindication to anticoagulation medication, such as bleeding disorders, high fall risk (e.g., severe alcoholism), severe thrombocytopenia, or severe anemia
- Concurrent use of antiplatelet medication
- Moderate to severe kidney failure (creatinine clearance less than 30 ml/min or on dialysis)
- Not a permanent resident in Finland (for Finnish patients) or Region Stockholm (for Swedish patients)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Oulu University Hospital
Oulu, North Ostrobothnia, Finland, 90220
Not Yet Recruiting
2
Kuopio University Hospital
Kuopio, Northern Savonia, Finland, 70200
Not Yet Recruiting
3
Tampere University Hospital
Tampere, Pirkanmaa, Finland, 33520
Not Yet Recruiting
4
Turku University Hospital
Turku, Southwest Finland, Finland, 20520
Not Yet Recruiting
5
Helsinki University Hospital
Helsinki, Uusimaa, Finland, 00260
Actively Recruiting
6
Karolinska University Hospital
Stockholm, Region Stockholm, Sweden, 17164
Not Yet Recruiting
Research Team
R
Rahul Raj, MD, PhD
CONTACT
J
Jarno Satopää, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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