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| Name | Class |
|---|---|
| Tampere University Hospital | OTHER |
| Kuopio University Hospital | OTHER |
| Turku University Hospital | OTHER_GOV |
| Oulu University Hospital |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early resumption | Experimental | Oral anticoagulation therapy is resumed on the 5th postoperative day following burr-hole surgery for chronic subdural hematoma. |
|
| Late resumption | Active Comparator | Oral anticoagulation therapy is resumed on the 30th postoperative day following burr-hole surgery for chronic subdural hematoma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Resumption of Oral Anticoagulation Therapy | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of different components of the primary composite outcome | Separation of the components of the primary composite outcome (thromboembolic, hemorrhagic, vascular death). | 90 days |
| Rate of patients with favorable functional outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rahul Raj, MD, PhD | Contact | +358504272516 | rahul.raj@hus.fi | |
| Jarno Satopää, MD, PhD | Contact | +358504286743 | jarno.satopaa@hus.fi |
| Name | Affiliation | Role |
|---|---|---|
| Rahul Raj, MD, PhD | Helsinki University Hospital & University of Helsinki | Study Chair |
| Jarno Satopää, MD, PhD | Helsinki University Hospital & University of Helsinki | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oulu University Hospital | Not yet recruiting | Oulu | North Ostrobothnia | 90220 | Finland |
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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| OTHER |
| Karolinska University Hospital | OTHER |
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Outcome assessor masking and blinded data interpretation.
|
| Late Resumption of Oral Anticoagulation Therapy | Drug | 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. |
|
Assessed using the modified Rankin Scale (mRS), which ranges from 0 (no symptoms) to 6 (death).
| 90 days |
| Rate of reoperation | Reoperation for the initially treated chronic subdural hematoma. | 90 days |
| Rate of all-cause mortality | 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 | 90 days |
| 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 |
| Nils Danner, MD, PhD | Kuopio University Hospital and University of Eastern Finland | Principal Investigator |
| Oula Knuutinen, MD, PhD | Oulu University Hospital and University of Oulu | Principal Investigator |
| Jiri Bartek, MD, PhD | Karolinska University Hospital | Principal Investigator |
| Kuopio University Hospital | Not yet recruiting | Kuopio | Northern Savonia | 70200 | Finland |
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| Tampere University Hospital | Not yet recruiting | Tampere | Pirkanmaa | 33520 | Finland |
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| Turku University Hospital | Not yet recruiting | Turku | Southwest Finland | 20520 | Finland |
|
| Helsinki University Hospital | Recruiting | Helsinki | Uusimaa | 00260 | Finland |
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| Karolinska University Hospital | Not yet recruiting | Stockholm | Region Stockholm | 17164 | Sweden |
|
| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006406 | Hematoma |
| D014947 | Wounds and Injuries |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
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