Hemorrhage BrainNCT07631936
Delayed Intracranial Hemorrhages in Patients With Minor Head Injury on Anticoagulant or Dual Anti-platelet Therapy
An observational study of Hemorrhage Brain, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage Brain
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2024to Dec 2026
- Phase
- Observational
- 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
Study population: Adult patients admitted to the ER with minor traumatic head injury
Who may be able to join
- Age ≥ 18
- Minor head injury (GCS ≥ 13)
- Current anticoagulant or dual antiplatelet therapy
- ED admission for head injury
Who cannot join
- Not meeting the full set of inclusion criteria.
Trial locations and contacts
1 site in 1 country.
Italy1 site
U.O. Pronto Soccorso - DEA II Livello IRCCS Ospedale San Raffaele Via Olgettina 60, 20132, Milano
Milan
About this study
Official 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.
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
- Medical subject headings
- Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Traumatic brain injury ANTICOAGULANT | TBI with anticoagulant treatment | |
| Traumatic brain injury DUALANTIPLATELET | TBI with dual-antiplatelet treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: From enrollment to the end of ED observation at 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 Jan 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemorrhage BrainStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giacomo Leso, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631936
- Sponsor's protocol ID
- TBI-ICH-2025
- Status last verified
- Jun 2026
- First submitted
- 20 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
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
- 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.
- ClinicalTrials.gov ID
- NCT07631936
- Acronym / sponsor ID
- TBI-ICH-2025
- Conditions
- Hemorrhage Brain
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Jun 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traumatic brain injury ANTICOAGULANT | – | –TBI with anticoagulant treatment |
| Traumatic brain injury DUALANTIPLATELET | – | –TBI with dual-antiplatelet treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the ER with minor traumatic head injury
Key inclusion criteria (4 listed)
- Age ≥ 18
- Minor head injury (GCS ≥ 13)
- Current anticoagulant or dual antiplatelet therapy
- ED admission for head injury
Key exclusion criteria (1 listed)
- Not meeting the full set of inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
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.
- Background1. 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.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhage Brain, run by IRCCS San Raffaele at 1 site in Italy.
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 4 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: under way, not looking for participants, 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 Italy. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07631936, which also lists 1 linked publication.
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.