Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this randomized, blinded, placebo controlled clinical study is to compare the peri- and postoperative bleeding and cardiovascular complication rates of patients undergoing burr-hole trepanation for chronic subdural hematoma with and without discontinuation of low-dose aspirin
Chronic subdural hematoma (cSDH) is one of the most common neurosurgical conditions. Its significantly higher prevalence among patients older than 65 (69%) versus younger (31%) explains why 41% of the patients are taking blood thinners. Antiplatelet therapy in patients with chronic subdural hematoma (cSDH) presents significant neurosurgical challenges. Studies investigating the effect of acetylsalicylic acid (ASA) in cranial neurosurgery are sparse and mostly based on case reports. Given the lack of guidelines regarding perioperative management with antiplatelet therapy, it is difficult to balance the patient's increased cardiovascular risk and prevalence of cSDH. The aim of our randomized, blinded, placebo controlled clinical study is to compare the peri- and postoperative bleeding and cardiovascular complication rates of patients undergoing burr-hole trepanation for cSDH with and without discontinuation of low-dose ASA. We will include patients receiving low-dose ASA as secondary prophylaxis for various reasons (e.g. coronary artery disease (CAD), cerebrovascular disease, etc.) and will randomize them either to a Placebo- or Aspirin-arm. The patients will receive placebo or ASA for 12 days whereas the normal ASA treatment will be resumed 12 days after randomization. Our study primarily seeks to evaluate the risk of recurrence after burr-hole trepanation for cSDH under low-dose ASA treatment compared to placebo treatment. Secondary objectives are to assess the rate of thrombotic events, perioperative blood loss, postoperative anemia, intra- and postoperative blood transfusion rate, and clinical outcome (mRS, GOS, Markwalder score). The study will be performed in cooperation with the Department of Cardiology of the University Hospital of Basel.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin Arm | Active Comparator | The patients will receive acetylsalicylic acid (100mg once a day, orally) for 12 days whereas the normal ASA treatment will be resumed 12 days after randomization |
|
| Placebo Arm | Placebo Comparator | The patients will receive placebo oral tablets for 12 days whereas the normal ASA treatment will be resumed 12 days after randomization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetylsalicylic acid | Drug | Patients will receive acetylsalicylic acid 100mg daily for 12 days after randomization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Revision surgery due to a recurrent subdural hematoma | Recurrence of chronic subdural hematoma requiring revision surgery (burr-hole drainage) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial infarction | (STEMI/non-STEMI) | 6 months |
| Stroke | cerebral stroke | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Luigi Mariani, Prof, MD | Department of Neurosurgery, University Hospital Basel | Study Chair |
| Maria Kamenova, MD | Department of Neurosurgery, University Hospital Basel | Principal Investigator |
| Jehuda Soleman, MD | Department of Neurosurgery, University Hospital Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurosurgery | Basel | 4053 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40287938 | Derived | Kamenova M, Pacan L, Mueller C, Coslovsky M, Lutz K, Marbacher S, Moser M, Hickmann AK, Zweifel C, Guzman R, Mariani L, Soleman J; SECA Investigators. Aspirin Continuation or Discontinuation in Surgically Treated Chronic Subdural Hematoma: A Randomized Clinical Trial. JAMA Neurol. 2025 Jun 1;82(6):551-559. doi: 10.1001/jamaneurol.2025.0850. | |
| 30665464 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| D020300 | Intracranial Hemorrhages |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
Not provided
Not provided
randomized, placebo controlled, double blinded study
Not provided
Not provided
double blinded study
| Placebo Oral Tablet | Drug | Patients will receive placebo medication 100mg daily for 12 days after randomization |
|
|
| Peripheral arterial occlusion | occlusion of a peripheral artery | 6 months |
| Other bleeding events apart from recurrent chronic subdural hematoma managed operatively or conservatively | acute subdural hematoma (aSDH), acute epidural hematoma (EDH), intraparenchymal bleeding) | 6 months |
| Intraoperative blood loss | blood loss recorded during surgery | on the operation day (up to 1 day) |
| Amount of blood/ fluid collected in the drain | Amount of blood/ fluid collected in the drain | up to 2 days, at removal of the drainage |
| Postoperative anemia | hemoglobin<80mg/L | up to 7 days |
| Operation time | Operation time | during surgery |
| Hospitalization time | Hospitalization time | an average of 7 days |
| Intraoperative blood transfusion rate | blood transfusion rate intraoperatively | during surgery (e.g. up to 1 day) |
| Postoperative blood transfusion rate | blood transfusion rate postoperatively | during hospitalization, an average of 7 days |
| GCS Score | Glasgow Coma Scale | 6 months |
| mRS | modified Rankin scale | 6 months |
| GOS | Glasgow Outcome Scale | 6 months |
| Clinical outcome | Markwalder Score | 6 months |
| Kamenova M, Mueller C, Coslovsky M, Guzman R, Mariani L, Soleman J. Low-dose aspirin and burr-hole drainage of chronic subdural hematoma: study protocol for a randomized controlled study. Trials. 2019 Jan 21;20(1):70. doi: 10.1186/s13063-018-3064-y. |
| 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 |
| D006470 | Hemorrhage |
| D014947 | Wounds and Injuries |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |