Hematoma, SubduralPAPAYENCT06415422
Platelet Activity Monitoring for Patients Under Adp Medication Using Verify Now in Subdural Hematoma
A study testing Biological samples in people with Hematoma, Subdural, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematoma, Subdural
- What is being tested?
- Biological samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2026to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient under effective anticoagulation or on antiplatelet therapy other than acetylsalicylic acid (combination of two antiplatelets) Pregnant or breastfeeding woman Refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Chu de Brest - Reanimation
Brest, 29200
Anaïs CAILLARD, Pr, 02 30 34 76 23, Anais.caillard@chu-brest.fr
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.
Read the 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.
- Conditions
- Hematoma, Subdural
- Being tested
- Biological samples
- Medical subject headings
- Hematoma, Subdural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samplesBiological
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).
| Study group | Role | What they receive |
|---|---|---|
| Daily Sampling in Platelet Function | Other | 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. Receives: Biological: Biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Day 5
Secondary outcomes (24)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after intervention
Evaluation of Incidence of Platelet Transfusion
Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time
Measured: Day 0
Evaluation of Incidence of Platelet Transfusion
Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time
Measured: Day 1
Evaluation of Incidence of Platelet Transfusion
Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time
Measured: Day 2
Evaluation of Incidence of Platelet Transfusion
Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time
Measured: Day 3
Evaluation of Incidence of Platelet Transfusion
Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time
Measured: Day 4
Evaluation of Incidence of Platelet Transfusion
Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematoma, SubduralStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415422
- Sponsor's protocol ID
- 29BRC22.0226
- Acronym
- PAPAYE
- Status last verified
- Jun 2026
- First submitted
- 3 May 2024
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Activity Monitoring for Patients Under Adp Medication Using Verify Now in Subdural Hematoma
- ClinicalTrials.gov ID
- NCT06415422
- Acronym / sponsor ID
- PAPAYE / 29BRC22.0226
- Conditions
- Hematoma, Subdural
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daily Sampling in Platelet Function | Other | Biological: Biological samplesThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patient under effective anticoagulation or on antiplatelet therapy other than acetylsalicylic acid (combination of two antiplatelets) Pregnant or breastfeeding woman Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological samplesBiological 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). | Biological | Daily Sampling in Platelet Function |
Primary outcome
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
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
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
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.
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
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
24 secondary outcomes
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
Evaluation of Incidence of Platelet Transfusion
Time frame: Day 5
Comparison of the total duration of antiplatelet cessation
Time frame: Day 0
Comparison of the total duration of antiplatelet cessation
Time frame: Day 1
Comparison of the total duration of antiplatelet cessation
Time frame: Day 2
Comparison of the total duration of antiplatelet cessation
Time frame: Day 3
Comparison of the total duration of antiplatelet cessation
Time frame: Day 4
Comparison of the total duration of antiplatelet cessation
Time frame: Day 5
Evaluation of cardiovascular complications
Time frame: Month 3
Evaluation of cardiovascular complications
Time frame: Month 6
Evaluation of the mRs score
Time frame: Immediately after discharge
Evaluation of the mRs score
Time frame: Month 3
Evaluation of the mRs score
Time frame: Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological samples in people with Hematoma, Subdural, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anaïs CAILLARD (+33, anais.caillard@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Platelet Function Progression (time frame: Day 0). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.