Restarting Early Versus Later Anticoagulation for Chronic Subdural Hematoma With Atrial Fibrillation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Early Resumption of Oral Anticoagulation Therapy, Late Resumption of Oral Anticoagulation Therapy.
- Who it may be relevant to
- Registry conditions: Chronic Subdural Hematoma, Atrial Fibrillation (AF). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland, Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Restarting Early Versus Later Anticoagulation for Chronic Subdural Hematoma With Atrial Fibrillation (RELACS): An International Multicenter, Randomized Controlled, Two-arm, Assessor-blinded, Trial
Overview
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
- Drug Early 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. - Drug Late 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.
Primary outcome measures
- Rate of composite outcome of vascular events [Time frame: 90 days]
Secondary outcome measures (5)
- Rate of different components of the primary composite outcome [Time frame: 90 days]
- Rate of patients with favorable functional outcome [Time frame: 90 days]
- Rate of reoperation [Time frame: 90 days]
- Rate of all-cause mortality [Time frame: 90 days and 12 months]
- Participants' healthcare use [Time frame: 90 days]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Finland · 5 centers
- Oulu University Hospital — Oulu
- Kuopio University Hospital — Kuopio
- Tampere University Hospital — Tampere
- Turku University Hospital — Turku
- Helsinki University Hospital — Helsinki
Sweden · 1 center
- Karolinska University Hospital — Stockholm
Identifiers
NCT: NCT06696079 · HUS/7351/2024