Clinical trial NCT05868525: Stroke Rate in Patients With Blunt Cerebrovascular Injury (BCVI) Treated With Oral Acetylsalicylic Acid (ASA) 81 mg Versus ASA 325 mg (BASA).
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).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Blunt Cerebrovascular Injury
Keywords: Blunt cerebrovascular injury
BCVI
Carotid artery
Vertebral Artery
Internal Carotid Artery
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* Age ≥18
* All patients with blunt cerebrovascular injury are diagnosed by computed tomography angiography (CTA) upon admission

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Number of patients with new stroke event (ischemic stroke or hemorrhagic stroke)
timeFrame: From randomization up to 3 months after discharge
Secondary outcomes:
measure: Number of patients that experienced any Aspirin-related adverse events
timeFrame: From randomization up to 3 months after discharge
measure: Rate of need for bleeding control operations/interventions in patients with solid organ injury
timeFrame: From randomization up to 30 day after randomization
measure: Need for blood product transfusion
timeFrame: From randomization up to 30 day after randomization
measure: Rate of any bleeding incidence
timeFrame: From randomization up to 30 day after randomization
measure: Number of patients that experienced any incidence of worsening brain hemorrhage
timeFrame: From randomization up to 30 day after randomization
measure: Any change in the percentage (%) of luminal stenosis in injured vessels of the neck and head
timeFrame: From randomization up to 3 months after discharge
measure: Change in severity of the neck and head vessels injury based on Biffl grading scale
timeFrame: From randomization up to 3 months after discharge
measure: In-hospital mortality rate
timeFrame: From randomization up to 30 day after randomization
measure: Out-patient mortality rate
timeFrame: From discharge up to 3 months after discharge
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
References:
citation: 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.
citation: Miller 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.
citation: Miller 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.
citation: Griffin 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.
citation: Catapano 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.
citation: Cothren 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.
citation: Shahan 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.
citation: McNutt 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.
citation: Callcut 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.
citation: Biffl 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.
citation: Harrigan 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.
citation: Biffl 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.
citation: Malhotra 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.
citation: Harrigan 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.
citation: DuBose 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.