Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06415422
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-03
Brief Title:
Platelet Activity Monitoring for Patients Under Adp Medication Using Verify Now in Subdural Hematoma
Sponsor:
University Hospital Brest
Organization:
University Hospital Brest
Study Overview
Official Title:
Platelet Activity Monitoring for Patients Under Adp Medication Using Verify Now in Subdural Hematoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAPAYE
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None