## Protocol Section
### Identification Module
**NCT ID:** NCT06415422

**Acronym:** PAPAYE

**Brief Title:** Platelet Activity Monitoring for Patients Under Adp Medication Using Verify Now in Subdural Hematoma

**Official Title:** Platelet Activity Monitoring for Patients Under Adp Medication Using Verify Now in Subdural Hematoma

#### Organization Study ID Info
**ID:** 29BRC22.0226
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Brest
### Status Module
#### Completion Date
**Date:** 2026-08-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-02-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-08-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-03
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Brest

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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 Module

**Conditions:**

- Hematoma, Subdural

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Biological: Biological samples

**Label:** Daily Sampling in Platelet Function

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Daily Sampling in Platelet Function

**Description:** 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).

**Name:** Biological samples

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Evaluation of Platelet Function Progression

**Time Frame:** Day 0

**Description:** 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

**Measure:** Evaluation of Platelet Function Progression

**Time Frame:** Day 1

**Description:** 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

**Measure:** Evaluation of Platelet Function Progression

**Time Frame:** Day 2

**Description:** 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.

**Measure:** Evaluation of Platelet Function Progression

**Time Frame:** Day 3

**Description:** 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

**Measure:** Evaluation of Platelet Function Progression

**Time Frame:** Day 4

**Description:** 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

**Measure:** Evaluation of Platelet Function Progression

**Time Frame:** Day 5

#### Secondary Outcomes

**Description:** 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.

**Measure:** Comparison of platelet function measurement between calculation and VerifyNow

**Time Frame:** Day 0

**Description:** 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.

**Measure:** Comparison of platelet function measurement between calculation and VerifyNow

**Time Frame:** Day 1

**Description:** 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.

**Measure:** Comparison of platelet function measurement between calculation and VerifyNow

**Time Frame:** Day 2

**Description:** 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.

**Measure:** Comparison of platelet function measurement between calculation and VerifyNow

**Time Frame:** Day 3

**Description:** 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.

**Measure:** Comparison of platelet function measurement between calculation and VerifyNow

**Time Frame:** Day 4

**Description:** 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.

**Measure:** Comparison of platelet function measurement between calculation and VerifyNow

**Time Frame:** Day 5

**Description:** 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.

**Measure:** Comparison of the actual surgical management time with the theoretical formula-based time

**Time Frame:** Immediately after intervention

**Description:** Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time

**Measure:** Evaluation of Incidence of Platelet Transfusion

**Time Frame:** Day 0

**Description:** Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time

**Measure:** Evaluation of Incidence of Platelet Transfusion

**Time Frame:** Day 1

**Description:** Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time

**Measure:** Evaluation of Incidence of Platelet Transfusion

**Time Frame:** Day 2

**Description:** Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time

**Measure:** Evaluation of Incidence of Platelet Transfusion

**Time Frame:** Day 3

**Description:** Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time

**Measure:** Evaluation of Incidence of Platelet Transfusion

**Time Frame:** Day 4

**Description:** Evaluation of the Incidence of Platelet Transfusion on Actual Surgical Management Time

**Measure:** Evaluation of Incidence of Platelet Transfusion

**Time Frame:** Day 5

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

**Measure:** Comparison of the total duration of antiplatelet cessation

**Time Frame:** Day 0

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

**Measure:** Comparison of the total duration of antiplatelet cessation

**Time Frame:** Day 1

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

**Measure:** Comparison of the total duration of antiplatelet cessation

**Time Frame:** Day 2

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

**Measure:** Comparison of the total duration of antiplatelet cessation

**Time Frame:** Day 3

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

**Measure:** Comparison of the total duration of antiplatelet cessation

**Time Frame:** Day 4

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

**Measure:** Comparison of the total duration of antiplatelet cessation

**Time Frame:** Day 5

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

**Measure:** Evaluation of cardiovascular complications

**Time Frame:** Month 3

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

**Measure:** Evaluation of cardiovascular complications

**Time Frame:** Month 6

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

**Measure:** Evaluation of the mRs score

**Time Frame:** Immediately after discharge

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

**Measure:** Evaluation of the mRs score

**Time Frame:** Month 3

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

**Measure:** Evaluation of the mRs score

**Time Frame:** Month 6

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** anais.caillard@chu-brest.fr

**Name:** Anaïs CAILLARD

**Phone:** +33

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006470

- Term: Hemorrhage

- ID: D000010335

- Term: Pathologic Processes

- ID: D000020198

- Term: Intracranial Hemorrhage, Traumatic

- ID: D000020300

- Term: Intracranial Hemorrhages

- ID: D000002561

- Term: Cerebrovascular Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000006259

- Term: Craniocerebral Trauma

- ID: D000020196

- Term: Trauma, Nervous System

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M9493

- Name: Hematoma

- Relevance: HIGH

- As Found: Hematoma

- ID: M9495

- Name: Hematoma, Subdural

- Relevance: HIGH

- As Found: Hematoma, Subdural

- ID: M9556

- Name: Hemorrhage

- Relevance: LOW

- As Found: Unknown

- ID: M22113

- Name: Intracranial Hemorrhages

- Relevance: LOW

- As Found: Unknown

- ID: M22025

- Name: Intracranial Hemorrhage, Traumatic

- Relevance: LOW

- As Found: Unknown

- ID: M5810

- Name: Cerebrovascular Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M9349

- Name: Craniocerebral Trauma

- Relevance: LOW

- As Found: Unknown

- ID: M22023

- Name: Trauma, Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006408

- Term: Hematoma, Subdural

- ID: D000006406

- Term: Hematoma

### Misc Info Module

- Version Holder: 2024-05-31
