Blunt Cerebrovascular InjuryPhase 4BASANCT05868525
Stroke Rate in Patients With Blunt Cerebrovascular Injury (BCVI) Treated With Oral Acetylsalicylic Acid (ASA) 81 mg Versus ASA 325 mg (BASA).
A Phase 4 study testing Aspirin 325Mg Tab, Aspirin 81Mg Tab in people with Blunt Cerebrovascular Injury, run by Loma Linda University at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare difference between Aspirin 81 mg and Aspirin 325 mg in preventing strokes in patients with head and neck vessels injury. The main questions it aims to answer are: If Aspirin 81 mg efficacy in prevention of stroke in patients with head and neck vessels injury is not lower… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blunt Cerebrovascular Injury
- What is being tested?
- Aspirin 325Mg Tab, Aspirin 81Mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2023to Dec 2026
- Phase
- Phase 4
- 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
- Age ≥18
- All patients with blunt cerebrovascular injury are diagnosed by computed tomography angiography (CTA) upon admission
Who cannot join
- Age <18
- Pregnant women
- No enteral route access for Aspirin administration
- Patients who are on Heparin drip or other full dose anticoagulation when BCVI diagnosed
- Patients who are on other Anti-Platelets aside from Aspirin when BCVI diagnosed
- Patients with BCVI grade 5 injury based on Biffl classification
Show all 9Show fewer
- Presence of any contraindication or history of allergy to Aspirin
- Patient with the diagnosis of acute stroke at the time of BCVI diagnosis matching the injured vessel territory on imaging
- Patients with acute spinal trauma that needs surgical intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Loma Linda University Medical Center
Loma Linda, California, 92354
Maryam Tabrizi, M.D, 904-576-5045, Mtabrizi@llu.edu
About this study
Official title: Pilot, Non-masked, Randomized Clinical Trial for Evaluation of Stroke Rate in Patients With Blunt Cerebrovascular Injury (BCVI) Treated With Oral Acetylsalicylic Acid (ASA) 81 mg Versus ASA 325 mg (BASA).
The goal of this clinical trial is to compare difference between Aspirin 81 mg and Aspirin 325 mg in preventing strokes in patients with head and neck vessels injury.
The main questions it aims to answer are:
- If Aspirin 81 mg efficacy in prevention of stroke in patients with head and neck vessels injury is not lower than and Aspirin 325 mg.
- If rate of hemorrhagic complications in patients with head and neck vessels injury taking Aspirin 81 mg is not higher than patients that take Aspirin 325 mg.
- Conditions
- Blunt Cerebrovascular Injury
- Being tested
- Aspirin 325Mg Tab, Aspirin 81Mg Tab
- Keywords
- Blunt cerebrovascular injury, BCVI, Carotid artery, Vertebral Artery, Internal Carotid Artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 325Mg Tab, Aspirin 81Mg TabDrug
Patients will be administrated daily oral Aspirin 81 mg or oral Aspirin 325 mg according to their assigned group after randomization.
| Study group | Role | What they receive |
|---|---|---|
| Oral Daily Aspirin 81 mg | Active comparator | Not described Receives: Drug: Aspirin 325Mg Tab, Aspirin 81Mg Tab |
| Oral Daily Aspirin 325 mg | Active comparator | Not described Receives: Drug: Aspirin 325Mg Tab, Aspirin 81Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with new stroke event (ischemic stroke or hemorrhagic stroke)
Measured: From randomization up to 3 months after discharge
Secondary outcomes (9)
Number of patients that experienced any Aspirin-related adverse events
An allergic reaction or gastrointestinal bleeding
Measured: From randomization up to 3 months after discharge
Rate of need for bleeding control operations/interventions in patients with solid organ injury
Measured: From randomization up to 30 day after randomization
Need for blood product transfusion
Measured: From randomization up to 30 day after randomization
Rate of any bleeding incidence
major or minor bleeds define according to the International Society of Thrombosis and Hemostasis (ISTH)
Measured: From randomization up to 30 day after randomization
Number of patients that experienced any incidence of worsening brain hemorrhage
Measured: From randomization up to 30 day after randomization
Any change in the percentage (%) of luminal stenosis in injured vessels of the neck and head
Measured: From randomization up to 3 months after discharge
Change in severity of the neck and head vessels injury based on Biffl grading scale
Measured: From randomization up to 3 months after discharge
In-hospital mortality rate
Measured: From randomization up to 30 day after randomization
Out-patient mortality rate
Measured: From discharge up to 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start23 Aug 2023
- 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 (15)Papers the sponsor has linked to this study.
- Other trials for Blunt Cerebrovascular InjuryStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868525
- Sponsor's protocol ID
- 5220429
- Acronym
- BASA
- Status last verified
- Jan 2026
- First submitted
- 1 May 2023
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Brommeland T, Helseth E, Aarhus M, Moen KG, Dyrskog S, Bergholt B, Olivecrona Z, Jeppesen E. Best practice guidelines for blunt cerebrovascular injury (BCVI). Scand J Trauma Resusc Emerg Med. 2018 Oct 29;26(1):90. doi: 10.1186/s13049-018-0559-1.
PubMed 30373641Miller PR, Fabian TC, Croce MA, Cagiannos C, Williams JS, Vang M, Qaisi WG, Felker RE, Timmons SD. Prospective screening for blunt cerebrovascular injuries: analysis of diagnostic modalities and outcomes. Ann Surg. 2002 Sep;236(3):386-93; discussion 393-5. doi: 10.1097/01.SLA.0000027174.01008.A0.
PubMed 12192325Miller PR, Fabian TC, Bee TK, Timmons S, Chamsuddin A, Finkle R, Croce MA. Blunt cerebrovascular injuries: diagnosis and treatment. J Trauma. 2001 Aug;51(2):279-85; discussion 285-6. doi: 10.1097/00005373-200108000-00009.
PubMed 11493785Griffin RL, Falatko SR, Aslibekyan S, Strickland V, Harrigan MR. Aspirin for primary prevention of stroke in traumatic cerebrovascular injury: association with increased risk of transfusion. J Neurosurg. 2018 May 18;130(5):1520-1527. doi: 10.3171/2017.12.JNS172284. Print 2019 May 1.
PubMed 29775142Catapano JS, Israr S, Whiting AC, Hussain OM, Snyder LA, Albuquerque FC, Ducruet AF, Nakaji P, Lawton MT, Weinberg JA, Zabramski JM. Management of Extracranial Blunt Cerebrovascular Injuries: Experience with an Aspirin-Based Approach. World Neurosurg. 2020 Jan;133:e385-e390. doi: 10.1016/j.wneu.2019.09.013. Epub 2019 Sep 12.
PubMed 31521761Cothren CC, Biffl WL, Moore EE, Kashuk JL, Johnson JL. Treatment for blunt cerebrovascular injuries: equivalence of anticoagulation and antiplatelet agents. Arch Surg. 2009 Jul;144(7):685-90. doi: 10.1001/archsurg.2009.111.
PubMed 19620551Shahan CP, Magnotti LJ, McBeth PB, Weinberg JA, Croce MA, Fabian TC. Early antithrombotic therapy is safe and effective in patients with blunt cerebrovascular injury and solid organ injury or traumatic brain injury. J Trauma Acute Care Surg. 2016 Jul;81(1):173-7. doi: 10.1097/TA.0000000000001058.
PubMed 27027559McNutt MK, Kale AC, Kitagawa RS, Turkmani AH, Fields DW, Baraniuk S, Gill BS, Cotton BA, Moore LJ, Wade CE, Day A, Holcomb JB. Management of blunt cerebrovascular injury (BCVI) in the multisystem injury patient with contraindications to immediate anti-thrombotic therapy. Injury. 2018 Jan;49(1):67-74. doi: 10.1016/j.injury.2017.07.036. Epub 2017 Jul 31.
PubMed 28789779Callcut RA, Hanseman DJ, Solan PD, Kadon KS, Ingalls NK, Fortuna GR, Tsuei BJ, Robinson BR. Early treatment of blunt cerebrovascular injury with concomitant hemorrhagic neurologic injury is safe and effective. J Trauma Acute Care Surg. 2012 Feb;72(2):338-45; discussion 345-6. doi: 10.1097/TA.0b013e318243d978.
PubMed 22327975Biffl WL, Cothren CC, Moore EE, Kozar R, Cocanour C, Davis JW, McIntyre RC Jr, West MA, Moore FA. Western Trauma Association critical decisions in trauma: screening for and treatment of blunt cerebrovascular injuries. J Trauma. 2009 Dec;67(6):1150-3. doi: 10.1097/TA.0b013e3181c1c1d6. No abstract available.
PubMed 20009659Harrigan MR, Weinberg JA, Peaks YS, Taylor SM, Cava LP, Richman J, Walters BC. Management of blunt extracranial traumatic cerebrovascular injury: a multidisciplinary survey of current practice. World J Emerg Surg. 2011 Apr 8;6:11. doi: 10.1186/1749-7922-6-11.
PubMed 21477304Biffl WL, Moore EE, Ryu RK, Offner PJ, Novak Z, Coldwell DM, Franciose RJ, Burch JM. The unrecognized epidemic of blunt carotid arterial injuries: early diagnosis improves neurologic outcome. Ann Surg. 1998 Oct;228(4):462-70. doi: 10.1097/00000658-199810000-00003.
PubMed 9790336Malhotra A, Wu X, Seifert K, Tu L. Blunt Cerebrovascular Artery Injury and Stroke in Severely Injured Patients: An International Multicenter Analysis. World J Surg. 2018 Oct;42(10):3451. doi: 10.1007/s00268-018-4518-9. No abstract available.
PubMed 29383427Harrigan MR, Hadley MN, Dhall SS, Walters BC, Aarabi B, Gelb DE, Hurlbert RJ, Rozzelle CJ, Ryken TC, Theodore N. Management of vertebral artery injuries following non-penetrating cervical trauma. Neurosurgery. 2013 Mar;72 Suppl 2:234-43. doi: 10.1227/NEU.0b013e31827765f5. No abstract available.
PubMed 23417194DuBose J, Recinos G, Teixeira PG, Inaba K, Demetriades D. Endovascular stenting for the treatment of traumatic internal carotid injuries: expanding experience. J Trauma. 2008 Dec;65(6):1561-6. doi: 10.1097/TA.0b013e31817fd954.
PubMed 19077655
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, Non-masked, Randomized Clinical Trial for Evaluation of Stroke Rate in Patients With Blunt Cerebrovascular Injury (BCVI) Treated With Oral Acetylsalicylic Acid (ASA) 81 mg Versus ASA 325 mg (BASA).
- ClinicalTrials.gov ID
- NCT05868525
- Acronym / sponsor ID
- BASA / 5220429
- Conditions
- Blunt Cerebrovascular Injury
- Keywords
- Blunt cerebrovascular injury, BCVI, Carotid artery, Vertebral Artery, Internal Carotid Artery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 May 2023 (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 goal of this clinical trial is to compare difference between Aspirin 81 mg and Aspirin 325 mg in preventing strokes in patients with head and neck vessels injury.
The main questions it aims to answer are:
- If Aspirin 81 mg efficacy in prevention of stroke in patients with head and neck vessels injury is not lower than and Aspirin 325 mg.
- If rate of hemorrhagic complications in patients with head and neck vessels injury taking Aspirin 81 mg is not higher than patients that take Aspirin 325 mg.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Daily Aspirin 81 mg | Active comparator | Drug: Aspirin 325Mg Tab, Aspirin 81Mg Tab |
| Oral Daily Aspirin 325 mg | Active comparator | Drug: Aspirin 325Mg Tab, Aspirin 81Mg Tab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18
- All patients with blunt cerebrovascular injury are diagnosed by computed tomography angiography (CTA) upon admission
Key exclusion criteria (9 listed)
- Age <18
- Pregnant women
- No enteral route access for Aspirin administration
- Patients who are on Heparin drip or other full dose anticoagulation when BCVI diagnosed
- Patients who are on other Anti-Platelets aside from Aspirin when BCVI diagnosed
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 |
|---|---|---|
| Aspirin 325Mg Tab, Aspirin 81Mg TabPatients will be administrated daily oral Aspirin 81 mg or oral Aspirin 325 mg according to their assigned group after randomization. | Drug | Oral Daily Aspirin 325 mg, Oral Daily Aspirin 81 mg |
Primary outcome
Number of patients with new stroke event (ischemic stroke or hemorrhagic stroke)
Time frame: From randomization up to 3 months after discharge
9 secondary outcomes
Number of patients that experienced any Aspirin-related adverse events
Time frame: From randomization up to 3 months after discharge
Rate of need for bleeding control operations/interventions in patients with solid organ injury
Time frame: From randomization up to 30 day after randomization
Need for blood product transfusion
Time frame: From randomization up to 30 day after randomization
Rate of any bleeding incidence
Time frame: From randomization up to 30 day after randomization
Number of patients that experienced any incidence of worsening brain hemorrhage
Time frame: From randomization up to 30 day after randomization
Any change in the percentage (%) of luminal stenosis in injured vessels of the neck and head
Time frame: From randomization up to 3 months after discharge
Change in severity of the neck and head vessels injury based on Biffl grading scale
Time frame: From randomization up to 3 months after discharge
In-hospital mortality rate
Time frame: From randomization up to 30 day after randomization
Out-patient mortality rate
Time frame: From discharge up to 3 months after discharge
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 30 Jan 2026.
- Background: PubMed 30373641Brommeland T, Helseth E, Aarhus M, Moen KG, Dyrskog S, Bergholt B, Olivecrona Z, Jeppesen E. Best practice guidelines for blunt cerebrovascular injury (BCVI). Scand J Trauma Resusc Emerg Med. 2018 Oct 29;26(1):90. doi: 10.1186/s13049-018-0559-1.
- Background: PubMed 12192325Miller PR, Fabian TC, Croce MA, Cagiannos C, Williams JS, Vang M, Qaisi WG, Felker RE, Timmons SD. Prospective screening for blunt cerebrovascular injuries: analysis of diagnostic modalities and outcomes. Ann Surg. 2002 Sep;236(3):386-93; discussion 393-5. doi: 10.1097/01.SLA.0000027174.01008.A0.
- Background: PubMed 11493785Miller PR, Fabian TC, Bee TK, Timmons S, Chamsuddin A, Finkle R, Croce MA. Blunt cerebrovascular injuries: diagnosis and treatment. J Trauma. 2001 Aug;51(2):279-85; discussion 285-6. doi: 10.1097/00005373-200108000-00009.
- Background: PubMed 29775142Griffin RL, Falatko SR, Aslibekyan S, Strickland V, Harrigan MR. Aspirin for primary prevention of stroke in traumatic cerebrovascular injury: association with increased risk of transfusion. J Neurosurg. 2018 May 18;130(5):1520-1527. doi: 10.3171/2017.12.JNS172284. Print 2019 May 1.
- Background: PubMed 31521761Catapano JS, Israr S, Whiting AC, Hussain OM, Snyder LA, Albuquerque FC, Ducruet AF, Nakaji P, Lawton MT, Weinberg JA, Zabramski JM. Management of Extracranial Blunt Cerebrovascular Injuries: Experience with an Aspirin-Based Approach. World Neurosurg. 2020 Jan;133:e385-e390. doi: 10.1016/j.wneu.2019.09.013. Epub 2019 Sep 12.
- Background: PubMed 19620551Cothren CC, Biffl WL, Moore EE, Kashuk JL, Johnson JL. Treatment for blunt cerebrovascular injuries: equivalence of anticoagulation and antiplatelet agents. Arch Surg. 2009 Jul;144(7):685-90. doi: 10.1001/archsurg.2009.111.
- Background: PubMed 27027559Shahan CP, Magnotti LJ, McBeth PB, Weinberg JA, Croce MA, Fabian TC. Early antithrombotic therapy is safe and effective in patients with blunt cerebrovascular injury and solid organ injury or traumatic brain injury. J Trauma Acute Care Surg. 2016 Jul;81(1):173-7. doi: 10.1097/TA.0000000000001058.
- Background: PubMed 28789779McNutt MK, Kale AC, Kitagawa RS, Turkmani AH, Fields DW, Baraniuk S, Gill BS, Cotton BA, Moore LJ, Wade CE, Day A, Holcomb JB. Management of blunt cerebrovascular injury (BCVI) in the multisystem injury patient with contraindications to immediate anti-thrombotic therapy. Injury. 2018 Jan;49(1):67-74. doi: 10.1016/j.injury.2017.07.036. Epub 2017 Jul 31.
- Background: PubMed 22327975Callcut RA, Hanseman DJ, Solan PD, Kadon KS, Ingalls NK, Fortuna GR, Tsuei BJ, Robinson BR. Early treatment of blunt cerebrovascular injury with concomitant hemorrhagic neurologic injury is safe and effective. J Trauma Acute Care Surg. 2012 Feb;72(2):338-45; discussion 345-6. doi: 10.1097/TA.0b013e318243d978.
- Background: PubMed 20009659Biffl WL, Cothren CC, Moore EE, Kozar R, Cocanour C, Davis JW, McIntyre RC Jr, West MA, Moore FA. Western Trauma Association critical decisions in trauma: screening for and treatment of blunt cerebrovascular injuries. J Trauma. 2009 Dec;67(6):1150-3. doi: 10.1097/TA.0b013e3181c1c1d6. No abstract available.
- Background: PubMed 21477304Harrigan MR, Weinberg JA, Peaks YS, Taylor SM, Cava LP, Richman J, Walters BC. Management of blunt extracranial traumatic cerebrovascular injury: a multidisciplinary survey of current practice. World J Emerg Surg. 2011 Apr 8;6:11. doi: 10.1186/1749-7922-6-11.
- Background: PubMed 9790336Biffl WL, Moore EE, Ryu RK, Offner PJ, Novak Z, Coldwell DM, Franciose RJ, Burch JM. The unrecognized epidemic of blunt carotid arterial injuries: early diagnosis improves neurologic outcome. Ann Surg. 1998 Oct;228(4):462-70. doi: 10.1097/00000658-199810000-00003.
- 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 Phase 4 study testing Aspirin 325Mg Tab, Aspirin 81Mg Tab in people with Blunt Cerebrovascular Injury, run by Loma Linda University at 1 site in United States.
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 9 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: looking for participants now, as of the sponsor's last update on 30 Jan 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Maryam B Tabrizi, M.D ((909) 558-4286, MTabrizi@llu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with new stroke event (ischemic stroke or hemorrhagic stroke) (time frame: From randomization up to 3 months after discharge). 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 NCT05868525, which also lists 15 linked publications.
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 30 Jan 2026.