Clinical trial NCT06696079: Restarting Early Versus Later Anticoagulation for Chronic Subdural Hematoma With Atrial Fibrillation
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Subdural Hematoma
Atrial Fibrillation (AF)
Keywords: chronic subdural hematoma
atrial fibrillation
oral anticoagulation
warfarin
direct oral anticoagulants
surgery
stroke
hemorrhage
prognosis
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University Hospital
name: Kuopio University Hospital
name: Turku University Hospital
name: Oulu University Hospital
name: Karolinska University Hospital
First posted: 2024-11-19
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Rate of composite outcome of vascular events
timeFrame: 90 days
Secondary outcomes:
measure: Rate of different components of the primary composite outcome
timeFrame: 90 days
measure: Rate of patients with favorable functional outcome
timeFrame: 90 days
measure: Rate of reoperation
timeFrame: 90 days
measure: Rate of all-cause mortality
timeFrame: 90 days and 12 months
measure: Participants' healthcare use
timeFrame: 90 days
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
state: Pirkanmaa
city: Oulu
country: Finland
facility: Oulu University Hospital
state: Pohjois-Pohjanmaa
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: Pohjois-Savo
city: Helsinki
country: Finland
facility: Helsinki University Hospital
state: Uusimaa
city: Turku
country: Finland
facility: Turku University Hospital
state: Varsinais-Suomi
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
state: Region Stockholm
Study officials:
affiliation: Helsinki University Hospital & University of Helsinki
name: Rahul Raj, MD, PhD
role: STUDY_CHAIR
affiliation: Helsinki University Hospital & University of Helsinki
name: Jarno Satopää, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Turku University Hospital and University of Turku
name: Jussi P Posti, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University Hospital and Tampere University
name: Teemu Luoto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kuopio University Hospital and University of Eastern Finland
name: Nils Danner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oulu University Hospital and University of Oulu
name: Oula Knuutinen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska University Hospital
name: Jiri Bartek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: