Delayed Intracranial Hemorrhages in Patients With Minor Head Injury on Anticoagulant or Dual Anti-platelet Therapy

NCT07631936 | Active Not Recruiting

• 1 other identifier: TBI-ICH-2025
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Retrospective observational study on a cohort of 2 years to evaluate the incidence of brain hemorrhage present at control head CT scan executed after routine 24h observation period of ED stay in patients with minor head injury on anticoagulant therapy or DAPT with an initial negative head CT.

Conditions

Hemorrhage Brain

Outcome Measures

Primary Outcomes (1)

• To evaluate the incidence of brain hemorrhage present at control head CT scan executed after routine 24h observation period of ED stay in patients with minor head injury on anticoagulant therapy or DAPT with an initial negative head CT.

  To evaluate the incidence of brain hemorrhage present at control head CT scan executed after routine 24h observation period of ED stay in patients with minor head injury on anticoagulant therapy or DAPT with an initial negative head CT.

  From enrollment to the end of ED observation at 24 hours

Secondary Outcomes (1)

• To determine the incidence of a major brain hemorrhage (requiring neurosurgical intervention) or hospital admission at repeat (24h) head CT scan in patients with an initial negative CT.

  From enrollment to the end of ED observation at 24 hours

Study Arms (2)

Traumatic brain injury ANTICOAGULANT

TBI with anticoagulant treatment

Traumatic brain injury DUALANTIPLATELET

TBI with dual-antiplatelet treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to the ER with minor traumatic head injury

You may qualify if:

• Age ≥ 18
• Minor head injury (GCS ≥ 13)
• Current anticoagulant or dual antiplatelet therapy
• ED admission for head injury

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

U.O. Pronto Soccorso - DEA II Livello IRCCS Ospedale San Raffaele Via Olgettina 60, 20132, Milano

Milan, Italy

Location

Related Publications (1)

• 1. National Institute for Health and Care Excellence. Head Injury: assessment and management - Evidence review for admission and observation in hospital of people with head injury who are on anticoagulant or antiplatelet therapy after normal brain imaging or no indication for early imaging NICE guideline NG232. 2023. 2. Valente JH, Anderson JD, Paolo WF, Sarmiento K, omaszewski CA, Haukoos JS, et al. Clinical Policy: Critical Issues in the Management of Adult Patients Presenting to the Emergency Department With Mild Traumatic Brain Injury: pproved by ACEP Board of Directors, February 1, 2023 Clinical Policy Endorsed by the Emergency Nurses Association (April 5, 2023). Vol. 81, Annals of Emergency Medicine. Elsevier Inc.; 023. pag. e63-105. 3. Haydel M. Management of mild traumatic brain injury in the emergency department. Emerg Med Pract. 2025 Feb 15;27(Suppl 2):1-46. PMID: 39903864. 4. Hadwe S El, Assamadi M, Barrit S, Giannis D, Haidich AB, Goulis DG, et al. Delayed intracranial hemorrhage of patients with mild traumatic brain injury under antithrombotics on routine repeat CT scan: a systematic review and meta-analysis. Vol. 36, Brain Injury. 2022 5. Ethridge M, Keller J, Edhayan E. Risk of delayed intracranial hemorrhage in patients on anticoagulation with negative initial imaging. Am J Surg. 2021 Mar;221(3):606-608. doi: 10.1016/j.amjsurg.2021.01.011. Epub 2021 Jan 16. PMID: 33485622.

  BACKGROUND

MeSH Terms

Conditions

Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Emergency Department, Principal Investigator

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 8, 2026
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

IT (1)