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Not Yet Recruiting NCT06415422

Platelet Activity Monitoring for Patients Under Adp Medication Using Verify Now in Subdural Hematoma

Conditions: Hematoma, Subdural

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: University Hospital, Brest

Location: Chu de Brest - Reanimation Brest

Summary

The brain is encased in three membranes: the pia mater, arachnoid, and dura mater. A subdural hematoma is often a post-traumatic accumulation of blood between the dura mater and the brain, occurring when a trauma tears a small vein on the brain. As the hematoma expands, it compresses the brain, potentially leading to severe neurological symptoms that may require urgent surgical removal. Patients on antiplatelet therapy are at increased risk of larger subdural hematomas and higher morbidity. The reversibility of antiplatelet effects and the potential benefits of platelet transfusions to halt hematoma expansion or prevent significant re-bleeding during surgical management are still debated. The French Society of Anesthesia and Intensive Care (SFAR) recommends delaying neurosurgical interventions by 5 days if clinically tolerable, with platelet transfusions provided for urgent surgeries within this period. However, prolonged cessation of antithrombotic treatments increases the risk of perioperative thrombotic events. Literature also notes individual variability in the effectiveness of antiplatelet treatments. European guidelines suggest using platelet function analysis devices alongside standard laboratory coagulation monitoring in trauma patients suspected of platelet dysfunction (Level 2C). The 2019 SFAR guidelines for the emergency management of patients on antiplatelets do not recommend these devices outside of cardiovascular surgery due to a lack of studies.

Eligibility Criteria

Inclusion Criteria: Patient \>18 years old Patient managed for a subdural hematoma in neurosurgery or intensive care under Acetylsalicylic Acid (aspirin) regardless of the dose. No objection from the patient Exclusion Criteria: Patient under effective anticoagulation or on antiplatelet therapy other than acetylsalicylic acid (combination of two antiplatelets) Pregnant or breastfeeding woman Refusal to participate

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Source: ClinicalTrials.gov (NCT06415422). StuddyBuddy aggregates publicly available trial information.