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NCT Number: NCT06415422

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

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.

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Key information

Conditions

Hematoma, Subdural Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Hematoma Hemorrhage Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biological samples

Biological

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).

Primary outcomes

  1. Evaluation of Platelet Function Progression

    Time frame: Day 0

    Evaluation of the difference between the time to achieve functional platelets, measured by the analysis of platelet function and the recommended management delay by SFAR of 5 days after the cessation of the antiplatelet drug

  2. Evaluation of Platelet Function Progression

    Time frame: Day 1

    Evaluation of the difference between the time to achieve functional platelets, measured by the analysis of platelet function and the recommended management delay by SFAR of 5 days after the cessation of the antiplatelet drug

  3. Evaluation of Platelet Function Progression

    Time frame: Day 2

    Evaluation of the difference between the time to achieve functional platelets, measured by the analysis of platelet function and the recommended management delay by SFAR of 5 days after the cessation of the antiplatelet drug

  4. Evaluation of Platelet Function Progression

    Time frame: Day 3

    Evaluation of the difference between the time to achieve functional platelets, measured by the analysis of platelet function (defined by the time elapsed between the last intake of antiplatelet drugs and the normalization of platelet function measured by VeriFyNow), and the recommended management delay by SFAR of 5 days after the cessation of the antiplatelet drug

    An analysis of the kinetics of recovery of platelet function in patients on aspirin managed for a subdural hematoma will be conducted to assess this criterion.

  5. Evaluation of Platelet Function Progression

    Time frame: Day 4

    Evaluation of the difference between the time to achieve functional platelets, measured by the analysis of platelet function and the recommended management delay by SFAR of 5 days after the cessation of the antiplatelet drug

  6. Evaluation of Platelet Function Progression

    Time frame: Day 5

    Evaluation of the difference between the time to achieve functional platelets, measured by the analysis of platelet function and the recommended management delay by SFAR of 5 days after the cessation of the antiplatelet drug

Secondary outcomes

  1. Comparison of platelet function measurement between calculation and VerifyNow

    Time frame: Day 0

    Comparison of platelet function measurement calculated by the theoretical formula based on the patient's initial platelet count and a 10% daily platelet turnover rate, and the VeriFyNow.

  2. Comparison of platelet function measurement between calculation and VerifyNow

    Time frame: Day 1

    Comparison of platelet function measurement calculated by the theoretical formula based on the patient's initial platelet count and a 10% daily platelet turnover rate, and the VeriFyNow.

  3. Comparison of platelet function measurement between calculation and VerifyNow

    Time frame: Day 2

    Comparison of platelet function measurement calculated by the theoretical formula based on the patient's initial platelet count and a 10% daily platelet turnover rate, and the VeriFyNow.

  4. Comparison of platelet function measurement between calculation and VerifyNow

    Time frame: Day 3

    Comparison of platelet function measurement calculated by the theoretical formula based on the patient's initial platelet count and a 10% daily platelet turnover rate, and the VeriFyNow.

  5. Comparison of platelet function measurement between calculation and VerifyNow

    Time frame: Day 4

    Comparison of platelet function measurement calculated by the theoretical formula based on the patient's initial platelet count and a 10% daily platelet turnover rate, and the VeriFyNow.

  6. Comparison of platelet function measurement between calculation and VerifyNow

    Time frame: Day 5

    Comparison of platelet function measurement calculated by the theoretical formula based on the patient's initial platelet count and a 10% daily platelet turnover rate, and the VeriFyNow.

  7. Comparison of the actual surgical management time with the theoretical formula-based time

    Time frame: Immediately after intervention

    Description and comparison of the actual surgical management time and the time to achieve functional platelets calculated by the theoretical formula based on the initial platelet count of the patient and a 10% daily platelet turnover rate.

  8. Evaluation of Incidence of Platelet Transfusion

    Time frame: Day 0

    Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time

  9. Evaluation of Incidence of Platelet Transfusion

    Time frame: Day 1

    Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time

  10. Evaluation of Incidence of Platelet Transfusion

    Time frame: Day 2

    Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time

  11. Evaluation of Incidence of Platelet Transfusion

    Time frame: Day 3

    Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time

  12. Evaluation of Incidence of Platelet Transfusion

    Time frame: Day 4

    Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time

  13. Evaluation of Incidence of Platelet Transfusion

    Time frame: Day 5

    Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time

  14. Comparison of the total duration of antiplatelet cessation

    Time frame: Day 0

    Comparison of the total duration of antiplatelet cessation (from preoperative stop to resumption validated by neurosurgeons) between actual management and optimal management.

  15. Comparison of the total duration of antiplatelet cessation

    Time frame: Day 1

    Comparison of the total duration of antiplatelet cessation (from preoperative stop to resumption validated by neurosurgeons) between actual management and optimal management.

  16. Comparison of the total duration of antiplatelet cessation

    Time frame: Day 2

    Comparison of the total duration of antiplatelet cessation (from preoperative stop to resumption validated by neurosurgeons) between actual management and optimal management.

  17. Comparison of the total duration of antiplatelet cessation

    Time frame: Day 3

    Comparison of the total duration of antiplatelet cessation (from preoperative stop to resumption validated by neurosurgeons) between actual management and optimal management.

  18. Comparison of the total duration of antiplatelet cessation

    Time frame: Day 4

    Comparison of the total duration of antiplatelet cessation (from preoperative stop to resumption validated by neurosurgeons) between actual management and optimal management.

  19. Comparison of the total duration of antiplatelet cessation

    Time frame: Day 5

    Comparison of the total duration of antiplatelet cessation (from preoperative stop to resumption validated by neurosurgeons) between actual management and optimal management.

  20. Evaluation of cardiovascular complications

    Time frame: Month 3

    Evaluation of the number of cardiovascular complications occurring within 6 months (acute coronary syndrome, ischemic stroke, thrombophlebitis, or pulmonary embolism)

  21. Evaluation of cardiovascular complications

    Time frame: Month 6

    Evaluation of the number of cardiovascular complications occurring within 6 months (acute coronary syndrome, ischemic stroke, thrombophlebitis, or pulmonary embolism)

  22. Evaluation of the mRs score

    Time frame: Immediately after discharge

    Evaluation of the mRs (modified Rankin Scale) score at discharge from the neurosurgery department, and at 3 and 6 months.

  23. Evaluation of the mRs score

    Time frame: Month 3

    Evaluation of the mRs (modified Rankin Scale) score at discharge from the neurosurgery department, and at 3 and 6 months.

  24. Evaluation of the mRs score

    Time frame: Month 6

    Evaluation of the mRs (modified Rankin Scale) score at discharge from the neurosurgery department, and at 3 and 6 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Anaïs CAILLARD

CONTACT

[email protected]

+33

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: PAPAYE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 16, 2024
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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