Restarting Early versus Later Anticoagulation for Chronic Subdural Hematoma with Atrial Fibrillation (RELACS)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

HUS-Yhtymae

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

6 Jul 2025 → ongoing

Decision date (initial)

2025-06-04

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Helsinki University Hospital · Finska Läkaresällskapet · Svenska Kulturfonden · Medicinska Understödsföreningen Liv och Hälsa

External identifiers

EU CT number

2025-521179-29-00

ClinicalTrials.gov

NCT06696079

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

The primary objective of the RELACS trial is to estimate the net effect of early resumption versus late resumption of oral anticoagulation medication in patients with AF undergoing surgery for CSDH. Net effect is estimated by a composite outcome that combines thromboembolic events (ischemic stroke, systemic embolism), hemorrhagic events (intracranial hemorrhage, major extracranial bleeding) and vascular death.

Secondary objectives 1

1. The secondary objectives are to assess reoperations, functional outcome, all-cause mortality, separate vascular events and healthcare service use after early versus late resumption in patients with AF undergoing surgery for CSDH.

Conditions and MedDRA coding

Chronic subdural hematoma

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Age ≥18 years
2. Patients with a symptomatic unilateral or bilateral CSDH requiring burr-hole evacuation
3. Patients that are on an oral anticoagulation medication due to permanent, persistent or paroxysmal spontaneous atrial fibrillation previously known
4. Randomization done within 4 days of the surgery
5. Patients with cognitive impairment, including mild cognitive impairment or dementia, are eligible if a legally authorized representative can provide informed consent on their behalf, as detailed in the informed consent section
6. Patients on standard or reduced doses of oral anticoagulants for stroke prevention in atrial fibrillation are eligible. Reduced doses must be in accordance with approved dosing recommendations and clinical practice guidelines based on patient-specific factors such as renal function, age, and body weight.

Exclusion criteria 14

1. Intraoperative or immediate postoperative hemorrhagic complication
2. Contraindication to anticoagulation medication (for example bleeding disorder, documented high risk of fall [e.g. due to severe alcoholism], severe thrombocytopenia, severe anemia)
3. Concomitant use of antiplatelet medication
4. Moderate to severe renal insufficiency (creatinine clearance <30 ml/min or on dialysis)
5. Not a permanent resident in Finland (for Finnish patients) or not a permanent resident in Region Stockholm (Swedish patients)
6. CSDH requiring surgical treatment other than burr-hole evacuation (e.g. craniotomy)
7. Prior CSDH surgery within 12 months
8. Cerebrospinal fluid shunt
9. CSDH is in an arachnoid cyst
10. If the operated hematoma reveals to be a cerebrospinal fluid collection (hygroma)
11. 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)
12. Mechanical heart valve(s)
13. Moderate or severe mitral stenosis (other valvular diseases and biological valves are eligible)
14. Women of childbearing potential

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Thromboembolic events (ischemic stroke, systemic embolism)
2. Hemorrhagic events
3. Vascular death

Secondary endpoints 7

1. All-cause mortality
2. modified Rankin Scale
3. Reoperation of ipsilateral hematoma
4. Number and type of unscheduled emergency radiological examinations
5. Number of emergency department visits
6. Postoperative total hospitalization days, counted from the day of surgery
7. Separation of the components of the primary outcome

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

HUS-Yhtymae

Sponsor organisation

HUS-Yhtymae

Address

Stenbackinkatu 9

City

Helsinki

Postcode

00290

Country

Finland

Scientific contact point

Organisation

HUS-Yhtymae

Contact name

Rahul Raj

Public contact point

Organisation

HUS-Yhtymae

Contact name

Rahul Raj

Locations

2 EU/EEA countries · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 46 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications