Clinical trial NCT06415422: Platelet Activity Monitoring for Patients Under Adp Medication Using Verify Now in Subdural Hematoma
Official title: Platelet Activity Monitoring for Patients Under Adp Medication Using Verify Now in Subdural Hematoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hematoma, Subdural
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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

Primary outcomes:
measure: Evaluation of Platelet Function Progression
timeFrame: Day 0
measure: Evaluation of Platelet Function Progression
timeFrame: Day 1
measure: Evaluation of Platelet Function Progression
timeFrame: Day 2
measure: Evaluation of Platelet Function Progression
timeFrame: Day 3
measure: Evaluation of Platelet Function Progression
timeFrame: Day 4
measure: Evaluation of Platelet Function Progression
timeFrame: Day 5
Secondary outcomes:
measure: Comparison of platelet function measurement between calculation and VerifyNow
timeFrame: Day 0
measure: Comparison of platelet function measurement between calculation and VerifyNow
timeFrame: Day 1
measure: Comparison of platelet function measurement between calculation and VerifyNow
timeFrame: Day 2
measure: Comparison of platelet function measurement between calculation and VerifyNow
timeFrame: Day 3
measure: Comparison of platelet function measurement between calculation and VerifyNow
timeFrame: Day 4
measure: Comparison of platelet function measurement between calculation and VerifyNow
timeFrame: Day 5
measure: Comparison of the actual surgical management time with the theoretical formula-based time
timeFrame: Immediately after intervention
measure: Evaluation of Incidence of Platelet Transfusion
timeFrame: Day 0
measure: Evaluation of Incidence of Platelet Transfusion
timeFrame: Day 1
measure: Evaluation of Incidence of Platelet Transfusion
timeFrame: Day 2
measure: Evaluation of Incidence of Platelet Transfusion
timeFrame: Day 3
measure: Evaluation of Incidence of Platelet Transfusion
timeFrame: Day 4
measure: Evaluation of Incidence of Platelet Transfusion
timeFrame: Day 5
measure: Comparison of the total duration of antiplatelet cessation
timeFrame: Day 0
measure: Comparison of the total duration of antiplatelet cessation
timeFrame: Day 1
measure: Comparison of the total duration of antiplatelet cessation
timeFrame: Day 2
measure: Comparison of the total duration of antiplatelet cessation
timeFrame: Day 3
measure: Comparison of the total duration of antiplatelet cessation
timeFrame: Day 4
measure: Comparison of the total duration of antiplatelet cessation
timeFrame: Day 5
measure: Evaluation of cardiovascular complications
timeFrame: Month 3
measure: Evaluation of cardiovascular complications
timeFrame: Month 6
measure: Evaluation of the mRs score
timeFrame: Immediately after discharge
measure: Evaluation of the mRs score
timeFrame: Month 3
measure: Evaluation of the mRs score
timeFrame: Month 6
Other outcomes:
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