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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Daily Aspirin 81 mg | Active Comparator |
| |
| Oral Daily Aspirin 325 mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin 325Mg Tab, Aspirin 81Mg Tab | Drug | Patients will be administrated daily oral Aspirin 81 mg or oral Aspirin 325 mg according to their assigned group after randomization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with new stroke event (ischemic stroke or hemorrhagic stroke) | From randomization up to 3 months after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients that experienced any Aspirin-related adverse events | An allergic reaction or gastrointestinal bleeding | From randomization up to 3 months after discharge |
| Rate of need for bleeding control operations/interventions in patients with solid organ injury |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maryam B Tabrizi, M.D | Contact | (909) 558-4286 | MTabrizi@llu.edu | |
| Sina Asaadi, M.D | Contact | (412) 539-7088 | sasaadi@llu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Medical Center | Recruiting | Loma Linda | California | 92354 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30373641 | Background | 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. | |
| 12192325 | Background | 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. |
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| From randomization up to 30 day after randomization |
| Need for blood product transfusion | 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) | From randomization up to 30 day after randomization |
| Number of patients that experienced any incidence of worsening brain hemorrhage | From randomization up to 30 day after randomization |
| Any change in the percentage (%) of luminal stenosis in injured vessels of the neck and head | From randomization up to 3 months after discharge |
| Change in severity of the neck and head vessels injury based on Biffl grading scale | From randomization up to 3 months after discharge |
| In-hospital mortality rate | From randomization up to 30 day after randomization |
| Out-patient mortality rate | From discharge up to 3 months after discharge |
| 11493785 | Background | 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. |
| 29775142 | Background | 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. |
| 31521761 | Background | 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. |
| 19620551 | Background | 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. |
| 27027559 | Background | 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. |
| 28789779 | Background | 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. |
| 22327975 | Background | 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. |
| 20009659 | Background | 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. |
| 21477304 | Background | 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. |
| 9790336 | Background | 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. |
| 29383427 | Background | 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. |
| 23417194 | Background | 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. |
| 19077655 | Background | 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. |
| ID | Term |
|---|---|
| D001241 | Aspirin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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