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Not yet recruiting NCT06415422

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

No phase Interventional Hematoma, Subdural

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biological samples.
Who it may be relevant to
Registry conditions: Hematoma, Subdural. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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).

Primary outcome measures

  • Evaluation of Platelet Function Progression [Time frame: Day 0]
  • Evaluation of Platelet Function Progression [Time frame: Day 1]
  • Evaluation of Platelet Function Progression [Time frame: Day 2]
  • Evaluation of Platelet Function Progression [Time frame: Day 3]
  • Evaluation of Platelet Function Progression [Time frame: Day 4]
  • Evaluation of Platelet Function Progression [Time frame: Day 5]
Secondary outcome measures (12)
  • Comparison of platelet function measurement between calculation and VerifyNow [Time frame: Day 0]
  • Comparison of platelet function measurement between calculation and VerifyNow [Time frame: Day 1]
  • Comparison of platelet function measurement between calculation and VerifyNow [Time frame: Day 2]
  • Comparison of platelet function measurement between calculation and VerifyNow [Time frame: Day 3]
  • Comparison of platelet function measurement between calculation and VerifyNow [Time frame: Day 4]
  • Comparison of platelet function measurement between calculation and VerifyNow [Time frame: Day 5]
  • Comparison of the actual surgical management time with the theoretical formula-based time [Time frame: Immediately after intervention]
  • Evaluation of Incidence of Platelet Transfusion [Time frame: Day 0]
  • Evaluation of Incidence of Platelet Transfusion [Time frame: Day 1]
  • Evaluation of Incidence of Platelet Transfusion [Time frame: Day 2]
  • Evaluation of Incidence of Platelet Transfusion [Time frame: Day 3]
  • Evaluation of Incidence of Platelet Transfusion [Time frame: Day 4]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

France · 1 center
  • Chu de Brest - Reanimation — Brest

Identifiers

NCT: NCT06415422 · 29BRC22.0226

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗