An interventional study of Biological samples in Hematoma, Subdural, sponsored by University Hospital, Brest. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by University Hospital, Brest · Not applicable, Interventional, and Prevention
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 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.
44 studies on the registry are indexed under Hematoma, Subdural; 15 are open to participants now.
This study's planned enrollment of 40 is below the median of 105 across 30 interventional studies indexed under Hematoma, Subdural.
Browse Hematoma, Subdural studies →University Hospital, Brest is the lead sponsor of 601 studies on the registry; 136 are open to participants now.
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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
The management of patients included in this study is not altered from the standard recommended care. The only exception is the daily blood draw into a dry tube for decentralized analysis using VeriFyNow until the normalization of platelet function, which is not part of routine care.
Biological: 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).
Evaluation of Platelet Function Progression
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
Time frame: Day 0
Evaluation of Platelet Function Progression
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
Time frame: Day 1
Evaluation of Platelet Function Progression
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
Time frame: Day 2
Evaluation of Platelet Function Progression
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.
Time frame: Day 3
Evaluation of Platelet Function Progression
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
Time frame: Day 4
Evaluation of Platelet Function Progression
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
Time frame: Day 5
Comparison of platelet function measurement between calculation and VerifyNow
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.
Time frame: Day 0
Comparison of platelet function measurement between calculation and VerifyNow
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.
Time frame: Day 1
Comparison of platelet function measurement between calculation and VerifyNow
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.
Time frame: Day 2
Comparison of platelet function measurement between calculation and VerifyNow
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.
Time frame: Day 3
Comparison of platelet function measurement between calculation and VerifyNow
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.
Time frame: Day 4
Comparison of platelet function measurement between calculation and VerifyNow
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.
Time frame: Day 5
Comparison of the actual surgical management time with the theoretical formula-based time
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.
Time frame: Immediately after intervention
Evaluation of Incidence of Platelet Transfusion
Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time
Time frame: Day 0
Evaluation of Incidence of Platelet Transfusion
Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time
Time frame: Day 1
Evaluation of Incidence of Platelet Transfusion
Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time
Time frame: Day 2
Evaluation of Incidence of Platelet Transfusion
Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time
Time frame: Day 3
Evaluation of Incidence of Platelet Transfusion
Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time
Time frame: Day 4
Evaluation of Incidence of Platelet Transfusion
Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time
Time frame: Day 5
Comparison of the total duration of antiplatelet cessation
Comparison of the total duration of antiplatelet cessation (from preoperative stop to resumption validated by neurosurgeons) between actual management and optimal management.
Time frame: Day 0
Comparison of the total duration of antiplatelet cessation
Comparison of the total duration of antiplatelet cessation (from preoperative stop to resumption validated by neurosurgeons) between actual management and optimal management.
Time frame: Day 1
Comparison of the total duration of antiplatelet cessation
Comparison of the total duration of antiplatelet cessation (from preoperative stop to resumption validated by neurosurgeons) between actual management and optimal management.
Time frame: Day 2
Comparison of the total duration of antiplatelet cessation
Comparison of the total duration of antiplatelet cessation (from preoperative stop to resumption validated by neurosurgeons) between actual management and optimal management.
Time frame: Day 3
Comparison of the total duration of antiplatelet cessation
Comparison of the total duration of antiplatelet cessation (from preoperative stop to resumption validated by neurosurgeons) between actual management and optimal management.
Time frame: Day 4
Comparison of the total duration of antiplatelet cessation
Comparison of the total duration of antiplatelet cessation (from preoperative stop to resumption validated by neurosurgeons) between actual management and optimal management.
Time frame: Day 5
Evaluation of cardiovascular complications
Evaluation of the number of cardiovascular complications occurring within 6 months (acute coronary syndrome, ischemic stroke, thrombophlebitis, or pulmonary embolism)
Time frame: Month 3
Evaluation of cardiovascular complications
Evaluation of the number of cardiovascular complications occurring within 6 months (acute coronary syndrome, ischemic stroke, thrombophlebitis, or pulmonary embolism)
Time frame: Month 6
Evaluation of the mRs score
Evaluation of the mRs (modified Rankin Scale) score at discharge from the neurosurgery department, and at 3 and 6 months.
Time frame: Immediately after discharge
Evaluation of the mRs score
Evaluation of the mRs (modified Rankin Scale) score at discharge from the neurosurgery department, and at 3 and 6 months.
Time frame: Month 3
Evaluation of the mRs score
Evaluation of the mRs (modified Rankin Scale) score at discharge from the neurosurgery department, and at 3 and 6 months.
Time frame: Month 6
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Jul 2028, 24 months later.
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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