Stroke Rate in Patients With Blunt Cerebrovascular Injury (BCVI) Treated With Oral Acetylsalicylic Acid (ASA) 81 mg Versus ASA 325 mg (BASA).

Официальное название

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).

Обзор

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.

Вмешательства

• Препарат Aspirin 325Mg Tab, Aspirin 81Mg Tab
  Patients will be administrated daily oral Aspirin 81 mg or oral Aspirin 325 mg according to their assigned group after randomization.

Первичные конечные точки

• Number of patients with new stroke event (ischemic stroke or hemorrhagic stroke) [Срок оценки: From randomization up to 3 months after discharge]

Вторичные конечные точки (9)

• Number of patients that experienced any Aspirin-related adverse events [Срок оценки: From randomization up to 3 months after discharge]
• Rate of need for bleeding control operations/interventions in patients with solid organ injury [Срок оценки: From randomization up to 30 day after randomization]
• Need for blood product transfusion [Срок оценки: From randomization up to 30 day after randomization]
• Rate of any bleeding incidence [Срок оценки: From randomization up to 30 day after randomization]
• Number of patients that experienced any incidence of worsening brain hemorrhage [Срок оценки: From randomization up to 30 day after randomization]
• Any change in the percentage (%) of luminal stenosis in injured vessels of the neck and head [Срок оценки: From randomization up to 3 months after discharge]
• Change in severity of the neck and head vessels injury based on Biffl grading scale [Срок оценки: From randomization up to 3 months after discharge]
• In-hospital mortality rate [Срок оценки: From randomization up to 30 day after randomization]
• Out-patient mortality rate [Срок оценки: From discharge up to 3 months after discharge]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Loma Linda University Medical Center — Loma Linda

Публикации

• 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. PMID 30373641
• 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. PMID 12192325
• 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. PMID 11493785
• 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. PMID 29775142
• 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. PMID 31521761
• 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. PMID 19620551
• 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. PMID 27027559
• 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. PMID 28789779

Идентификаторы

NCT: NCT05868525 · 5220429

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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