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

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат Biological samples
  Biological samples are taken from the patient's catheter inserted upon admission (the usual access route for patients): A daily sample is collected into a dry tube for off-site analysis by VeriFyNow until platelet function normalizes (for example, if platelet function normalizes on Day 2, no further VeriFyNow analysis will be conducted on subsequent days).

Первичные конечные точки

• Evaluation of Platelet Function Progression [Срок оценки: Day 0]
• Evaluation of Platelet Function Progression [Срок оценки: Day 1]
• Evaluation of Platelet Function Progression [Срок оценки: Day 2]
• Evaluation of Platelet Function Progression [Срок оценки: Day 3]
• Evaluation of Platelet Function Progression [Срок оценки: Day 4]
• Evaluation of Platelet Function Progression [Срок оценки: Day 5]

Вторичные конечные точки (12)

• Comparison of platelet function measurement between calculation and VerifyNow [Срок оценки: Day 0]
• Comparison of platelet function measurement between calculation and VerifyNow [Срок оценки: Day 1]
• Comparison of platelet function measurement between calculation and VerifyNow [Срок оценки: Day 2]
• Comparison of platelet function measurement between calculation and VerifyNow [Срок оценки: Day 3]
• Comparison of platelet function measurement between calculation and VerifyNow [Срок оценки: Day 4]
• Comparison of platelet function measurement between calculation and VerifyNow [Срок оценки: Day 5]
• Comparison of the actual surgical management time with the theoretical formula-based time [Срок оценки: Immediately after intervention]
• Evaluation of Incidence of Platelet Transfusion [Срок оценки: Day 0]
• Evaluation of Incidence of Platelet Transfusion [Срок оценки: Day 1]
• Evaluation of Incidence of Platelet Transfusion [Срок оценки: Day 2]
• Evaluation of Incidence of Platelet Transfusion [Срок оценки: Day 3]
• Evaluation of Incidence of Platelet Transfusion [Срок оценки: Day 4]

Критерии участия

Критерии включения

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

Критерии исключения

Patient under effective anticoagulation or on antiplatelet therapy other than acetylsalicylic acid (combination of two antiplatelets) Pregnant or breastfeeding woman Refusal to participate

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Франция · 1 центр

• Chu de Brest - Reanimation — Brest

Идентификаторы

NCT: NCT06415422 · 29BRC22.0226

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗