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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Milan, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Not meeting the full set of inclusion criteria.

Treatment and study plan

Primary outcomes

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.

Time frame: From enrollment to the end of ED observation at 24 hours

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.

Secondary outcomes

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.

Time frame: From enrollment to the end of ED observation at 24 hours

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.

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

Delayed Intracranial Hemorrhages in Patients With Minor Head Injury on Anticoagulant or Dual Anti-platelet Therapy: Role of Repeat Head CT Scan in the Emergency Department. A Single-center Retrospective Observational Study.

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Jun 8, 2026
Registry last updated: Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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