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Outcome Measures

Primary Outcomes (1)

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.
90 days

Secondary Outcomes (5)

Rate of different components of the primary composite outcome
90 days
Rate of patients with favorable functional outcome
90 days

Study Arms (2)

Early resumption

EXPERIMENTAL

Oral anticoagulation therapy is resumed on the 5th postoperative day following burr-hole surgery for chronic subdural hematoma.

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.

Drug: Late Resumption of Oral Anticoagulation Therapy

Interventions

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.

Early resumption

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.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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).

Study Sites (6)

Oulu University Hospital

Oulu, North Ostrobothnia, 90220, Finland

NOT_YET_RECRUITING

Oula Knuutinen, MD, PhDCONTACT‭+358405842879‬oula.knuutinen@oulu.fi

Oula Knuutinen, MD, PhDPRINCIPAL INVESTIGATOR

Tommi Korhonen, MD, PhDSUB INVESTIGATOR

Sami Tetri, MD, PhDSUB INVESTIGATOR

Kuopio University Hospital

Kuopio, Northern Savonia, 70200, Finland

NOT_YET_RECRUITING

MeSH Terms

Conditions

Hematoma, Subdural, ChronicAtrial FibrillationStrokeHemorrhage

Condition Hierarchy (Ancestors)

Hematoma, SubduralIntracranial Hemorrhage, TraumaticIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemVascular DiseasesCardiovascular Diseases

Study Officials

Rahul Raj, MD, PhD

Helsinki University Hospital & University of Helsinki

STUDY CHAIR

Jarno Satopää, MD, PhD

Helsinki University Hospital & University of Helsinki

PRINCIPAL INVESTIGATOR

Jussi P Posti, MD, PhD

Turku University Hospital and University of Turku

PRINCIPAL INVESTIGATOR

Teemu Luoto, MD, PhD

Tampere University Hospital and Tampere University

PRINCIPAL INVESTIGATOR

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

SINGLE

Who Masked

OUTCOMES ASSESSOR

Masking Details

Outcome assessor masking and blinded data interpretation.

Purpose

TREATMENT

Intervention Model

PARALLEL

Sponsor Type

OTHER

Responsible Party

SPONSOR INVESTIGATOR

PI Title

Sponsor Principal Investigator

Restarting Early Versus Later Anticoagulation for Chronic Subdural Hematoma With Atrial Fibrillation

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Early resumption

Late resumption

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Early resumption

Late resumption

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations