Ethical Justification for Deferral of Consent in the AcT Trial for Acute Ischemic Stroke-Reference-Cited by-同舟云学术

Ethical Justification for Deferral of Consent in the AcT Trial for Acute Ischemic Stroke

Published:2022-07 Issue:7 Volume:53 Page:2420-2423
ISSN:0039-2499
Container-title:Stroke
language:en
Short-container-title:Stroke

Author:

Faris Hannah¹²^ORCID,Dewar Brian²^ORCID,Dowlatshahi Dar¹²^ORCID,Ramji Alnar^ORCID,Kenney Carol³,Page Stacey⁴^ORCID,Buck Brian⁵^ORCID,Hill Michael D.³^ORCID,Coutts Shelagh B.³^ORCID,Almekhlafi Mohammed³^ORCID,Sajobi Tolulope³^ORCID,Singh Nishita³^ORCID,Sehgal Arshia³^ORCID,Swartz Richard H.⁶,Menon Bijoy K.³^ORCID,Shamy Michel¹²^ORCID

Affiliation:

1. Department of Medicine, University of Ottawa and The Ottawa Hospital, Ontario, Canada (H.F., D.D., M.S.).

2. Ottawa Hospital Research Institute, Ontario, Canada (H.F., B.D., D.D., M.S.).

3. Calgary Stroke Program, University of Calgary and Foothills Hospital, Alberta, Canada (C.K., M.D.H., S.B.C., M.A., T.S., N.S., A.S., B.K.M.).

4. Calgary Conjoint Health Research Ethics Board, Alberta, Canada (S.P.).

5. University of Alberta and University Hospital, Edmonton, Canada (B.B.).

6. University of Toronto and Sunnybrook Hospital, Ontario, Canada (R.H.S.).

Abstract

The AcT trial (Alteplase Compared to Tenecteplase) compares alteplase or tenecteplase for patients with acute ischemic stroke. All eligible patients are enrolled by deferral of consent. Although the use of deferral of consent in the AcT trial meets the requirements of Canadian policy, we sought to provide a more explicit and rigorous approach to the justification of deferral of consent organized around 3 questions. Ultimately, the approach we outline here could become the foundation for a general justification for deferral of consent.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Advanced and Specialized Nursing,Cardiology and Cardiovascular Medicine,Neurology (clinical)

Reference25 articles.

1. Informed Consent: The Rate-Limiting Step in Acute Stroke Trials

2. Effect of waivers of consent on recruitment in acute stroke trials

3. Randomized Assessment of Rapid Endovascular Treatment of Ischemic Stroke

4. Effect of Recombinant Activated Coagulation Factor VII on Hemorrhage Expansion Among Patients With Spot Sign–Positive Acute Intracerebral Hemorrhage

5. Bridging Thrombolysis Versus Direct Mechanical Thrombectomy in Acute Ischemic Stroke (SWIFT DIRECT). Accessed December 18 2021. https://clinicaltrials.gov/ct2/show/NCT03192332.

Cited by 7 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Tenecteplase Versus Alteplase in Medium Vessel Occlusion Ischemic Stroke: A Secondary Analysis of the Alteplase Compared to Tenecteplase Randomized Trial;Journal of Stroke;2024-05-31

2. Effect of Time to Thrombolysis on Clinical Outcomes in Patients With Acute Ischemic Stroke Treated With Tenecteplase Compared to Alteplase: Analysis From the AcT Randomized Controlled Trial;Stroke;2023-11

3. Advances in Stroke: A Focus on Health Policy Literature From 2022;Stroke;2023-09

4. Safety and Efficacy of Tenecteplase Compared With Alteplase in Patients With Large Vessel Occlusion Stroke;JAMA Neurology;2023-08-01

5. Effect of Time to Thrombolysis on Clinical Outcomes in Patients with Acute Ischemic Stroke Treated with Tenecteplase Compared to Alteplase: Analysis from the AcT Randomized Controlled Trial;2023-05-19