Chronic Subdural HematomaRELACSNCT06696079
Restarting Early Versus Later Anticoagulation for Chronic Subdural Hematoma With Atrial Fibrillation
A study testing Early Resumption of Oral Anticoagulation Therapy and Late Resumption of Oral Anticoagulation Therapy in people with Chronic Subdural Hematoma and Atrial Fibrillation (AF), run by Rahul Raj at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma, Atrial Fibrillation (AF)
- What is being tested?
- Early Resumption of Oral Anticoagulation Therapy and Late Resumption of Oral Anticoagulation Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 7 Jul 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
Finland5 sites, 5 recruiting
- Recruiting
Helsinki University Hospital
Helsinki, Uusimaa, 00260
Rahul Raj, MD, PhD, +358504272516, rahul.raj@hus.fi
Jarno Satopää, MD, PhD, +358504286743, jarno.satopaa@hus.fi
- Not yet recruiting
Kuopio University Hospital
Kuopio, Northern Savonia, 70200
Nils Danner, MD, PhD, +358400911568, nils.danner@pshyvinvointialue.fi
Nils Danner, MD, PhD
- Not yet recruiting
Oulu University Hospital
Oulu, North Ostrobothnia, 90220
Oula Knuutinen, MD, PhD, +358405842879, oula.knuutinen@oulu.fi
Oula Knuutinen, MD, PhD
- Not yet recruiting
Tampere University Hospital
Tampere, Pirkanmaa, 33520
Teemu Luoto, MD, PhD, +35840703 9696, teemu.luoto@pirha.fi
Teemu Luoto, MD, PhD
- Not yet recruiting
Turku University Hospital
Turku, Southwest Finland, 20520
Jussi P Posti, MD, PhD, +358443804143, jussi.posti@tyks.fi
Jussi P Posti, MD, PhD
Sweden1 site, 1 recruiting
- Not yet recruiting
Karolinska University Hospital
Stockholm, Region Stockholm, 17164
Jiri Bartek, MD, PhD, +46707948670, jiri.bartek@regionstockholm.se
Jiri Bartek, MD, PhD
About this study
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
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?
Read more
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.
- Being tested
- Early Resumption of Oral Anticoagulation Therapy, Late Resumption of Oral Anticoagulation Therapy
- Keywords
- chronic subdural hematoma, atrial fibrillation, oral anticoagulation, warfarin, direct oral anticoagulants, surgery, stroke, hemorrhage, prognosis
- Medical subject headings
- Hematoma, Subdural, Chronic, Atrial Fibrillation, Stroke, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Resumption of Oral Anticoagulation TherapyDrug
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.
Late Resumption of Oral Anticoagulation TherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Early resumption | Experimental | Oral anticoagulation therapy is resumed on the 5th postoperative day following burr-hole surgery for chronic subdural hematoma. Receives: Drug: Early Resumption of Oral Anticoagulation Therapy |
| Late resumption | Active comparator | Oral anticoagulation therapy is resumed on the 30th postoperative day following burr-hole surgery for chronic subdural hematoma. Receives: Drug: Late Resumption of Oral Anticoagulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of composite outcome of vascular events
Rate of the composite outcome that combines thromboembolic events (ischemic stroke, systemic embolism), hemorrhagic events (intracranial hemorrhage, major extracranial bleeding), and vascular death.
Measured: 90 days
Secondary outcomes (5)
Rate of different components of the primary composite outcome
Separation of the components of the primary composite outcome (thromboembolic, hemorrhagic, vascular death).
Measured: 90 days
Rate of patients with favorable functional outcome
Assessed using the modified Rankin Scale (mRS), which ranges from 0 (no symptoms) to 6 (death).
Measured: 90 days
Rate of reoperation
Reoperation for the initially treated chronic subdural hematoma.
Measured: 90 days
Rate of all-cause mortality
Measured: 90 days and 12 months
Participants' healthcare use
Number and type of unscheduled emergency radiological examinations, - number of emergency department visits, postoperative total hospitalization days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start7 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rahul Raj
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University Hospital, Kuopio University Hospital, Turku University Hospital, Oulu University Hospital, Karolinska University Hospital
- Responsible party
- Sponsor-investigator, Rahul Raj, Helsinki University Central Hospital
- Investigators
- Rahul Raj, MD, PhD, Study chair, Helsinki University Hospital & University of HelsinkiJarno Satopää, MD, PhD, Principal investigator, Helsinki University Hospital & University of HelsinkiJussi P Posti, MD, PhD, Principal investigator, Turku University Hospital and University of TurkuTeemu Luoto, MD, PhD, Principal investigator, Tampere University Hospital and Tampere UniversityNils Danner, MD, PhD, Principal investigator, Kuopio University Hospital and University of Eastern FinlandOula Knuutinen, MD, PhD, Principal investigator, Oulu University Hospital and University of OuluJiri Bartek, MD, PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696079
- Sponsor's protocol ID
- HUS/7351/2024
- Acronym
- RELACS
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Researcher-initiated data sharing is not possible due to the Finnish Secondary Use Act (552/2019). Thus, all requests to process data for purposes permitted by the Secondary Use Act are given based on an official decision made by FINDATA (https://findata.fi/en/).
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06696079
- Acronym / sponsor ID
- RELACS / HUS/7351/2024
- Keywords
- chronic subdural hematoma, atrial fibrillation, oral anticoagulation, warfarin, direct oral anticoagulants, surgery, stroke, hemorrhage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- Rahul RajUniversity, hospital or other
- Collaborators
- Tampere University Hospital, Kuopio University Hospital, Turku University Hospital, Oulu University Hospital, Karolinska University Hospital
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early resumption | Experimental | Drug: Early Resumption of Oral Anticoagulation TherapyOral anticoagulation therapy is resumed on the 5th postoperative day following burr-hole surgery for chronic subdural hematoma. |
| Late resumption | Active comparator | Drug: Late Resumption of Oral Anticoagulation TherapyOral anticoagulation therapy is resumed on the 30th postoperative day following burr-hole surgery for chronic subdural hematoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Resumption of Oral Anticoagulation TherapyThe 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 | Early resumption |
| Late Resumption of Oral Anticoagulation TherapyThe 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. | Drug | Late resumption |
Primary outcome
Rate of composite outcome of vascular events
Time frame: 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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No. Researcher-initiated data sharing is not possible due to the Finnish Secondary Use Act (552/2019). Thus, all requests to process data for purposes permitted by the Secondary Use Act are given based on an official decision made by FINDATA (https://findata.fi/en/).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rahul Raj, MD, PhD study chair
Helsinki University Hospital & University of Helsinki
Jarno Satopää, MD, PhD principal investigator
Helsinki University Hospital & University of Helsinki
Jussi P Posti, MD, PhD principal investigator
Turku University Hospital and University of Turku
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Resumption of Oral Anticoagulation Therapy and Late Resumption of Oral Anticoagulation Therapy in people with Chronic Subdural Hematoma and Atrial Fibrillation (AF), run by Rahul Raj at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Finland, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rahul Raj, MD, PhD (+358504272516, rahul.raj@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of composite outcome of vascular events (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.