Back to resultsStroke Rate in Patients With Blunt Cerebrovascular Injury (BCVI) Treated With Oral Acetylsalicylic Acid (ASA) 81 mg Versus ASA 325 mg (BASA). (BASA)
Primary Purpose
Blunt Cerebrovascular Injury
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aspirin 325Mg Tab, Aspirin 81Mg Tab
Sponsored by
About this trial
This is an interventional prevention trial for Blunt Cerebrovascular Injury focused on measuring Blunt cerebrovascular injury, BCVI, Carotid artery, Vertebral Artery, Internal Carotid Artery
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
Sites / Locations
- Loma Linda University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Oral Daily Aspirin 81 mg
Oral Daily Aspirin 325 mg
Arm Description
Outcomes
Primary Outcome Measures
Number of patients with new stroke event (ischemic stroke or hemorrhagic stroke)
Secondary Outcome Measures
Number of patients that experienced any Aspirin-related adverse events
An allergic reaction or gastrointestinal bleeding
Rate of need for bleeding control operations/interventions in patients with solid organ injury
Need for blood product transfusion
Rate of any bleeding incidence
major or minor bleeds define according to the International Society of Thrombosis and Hemostasis (ISTH)
Number of patients that experienced any incidence of worsening brain hemorrhage
Any change in the percentage (%) of luminal stenosis in injured vessels of the neck and head
Change in severity of the neck and head vessels injury based on Biffl grading scale
In-hospital mortality rate
Out-patient mortality rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05868525
Brief Title
Stroke Rate in Patients With Blunt Cerebrovascular Injury (BCVI) Treated With Oral Acetylsalicylic Acid (ASA) 81 mg Versus ASA 325 mg (BASA).
Acronym
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blunt Cerebrovascular Injury
Keywords
Blunt cerebrovascular injury, BCVI, Carotid artery, Vertebral Artery, Internal Carotid Artery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oral Daily Aspirin 81 mg
Arm Type
Active Comparator
Arm Title
Oral Daily Aspirin 325 mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Aspirin 325Mg Tab, Aspirin 81Mg Tab
Intervention Description
Patients will be administrated daily oral Aspirin 81 mg or oral Aspirin 325 mg according to their assigned group after randomization.
Primary Outcome Measure Information:
Title
Number of patients with new stroke event (ischemic stroke or hemorrhagic stroke)
Time Frame
From randomization up to 3 months after discharge
Secondary Outcome Measure Information:
Title
Number of patients that experienced any Aspirin-related adverse events
Description
An allergic reaction or gastrointestinal bleeding
Time Frame
From randomization up to 3 months after discharge
Title
Rate of need for bleeding control operations/interventions in patients with solid organ injury
Time Frame
From randomization up to 30 day after randomization
Title
Need for blood product transfusion
Time Frame
From randomization up to 30 day after randomization
Title
Rate of any bleeding incidence
Description
major or minor bleeds define according to the International Society of Thrombosis and Hemostasis (ISTH)
Time Frame
From randomization up to 30 day after randomization
Title
Number of patients that experienced any incidence of worsening brain hemorrhage
Time Frame
From randomization up to 30 day after randomization
Title
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
Title
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
Title
In-hospital mortality rate
Time Frame
From randomization up to 30 day after randomization
Title
Out-patient mortality rate
Time Frame
From discharge up to 3 months after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maryam B Tabrizi, M.D
Phone
(909) 558-4286
Email
MTabrizi@llu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sina Asaadi, M.D
Phone
(412) 539-7088
Email
sasaadi@llu.edu
Facility Information:
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maryam Tabrizi, M.D
Phone
904-576-5045
Email
Mtabrizi@llu.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30373641
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.
Results Reference
background
PubMed Identifier
12192325
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.
Results Reference
background
PubMed Identifier
11493785
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.
Results Reference
background
PubMed Identifier
29775142
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 18:1-8. doi: 10.3171/2017.12.JNS172284. Online ahead of print.
Results Reference
background
PubMed Identifier
31521761
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.
Results Reference
background
PubMed Identifier
19620551
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.
Results Reference
background
PubMed Identifier
27027559
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.
Results Reference
background
PubMed Identifier
28789779
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.
Results Reference
background
PubMed Identifier
22327975
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.
Results Reference
background
PubMed Identifier
20009659
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.
Results Reference
background
PubMed Identifier
21477304
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.
Results Reference
background
PubMed Identifier
9790336
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.
Results Reference
background
PubMed Identifier
29383427
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.
Results Reference
background
PubMed Identifier
23417194
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.
Results Reference
background
PubMed Identifier
19077655
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.
Results Reference
background
Learn more about this trial
Stroke Rate in Patients With Blunt Cerebrovascular Injury (BCVI) Treated With Oral Acetylsalicylic Acid (ASA) 81 mg Versus ASA 325 mg (BASA).
We'll reach out to this number within 24 hrs