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P-011 Exception from informed consent in acute stroke trials – the SEGA randomized stroke trial experience
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  1. P Chen1,
  2. C Artime2,
  3. S Sheth3,
  4. C Pedroza4,
  5. E Aguilar1,
  6. T Nguyen1,
  7. A Sanzgiri5,
  8. S Sridhar6,
  9. A Barreto7
  1. 1Neurosurgery, University of Texas McGovern Medical School, Houston, TX
  2. 2Anesthesiology, Carlos Artime, Houston, TX
  3. 3Neurology, Sunil Sheth, Houston, TX
  4. 4Pediatric, Claudia Pedroza, Houston, TX
  5. 5University of Chicago, Houston, TX
  6. 6University of Texas McGovern Medical School, Houston, TX
  7. 7Neurology, University of Texas McGovern Medical School, Houston, TX

Abstract

Introduction Patients with acute ischemic stroke (AIS) and neurologic deficits are often unable to provide consent and subsequently excluded from emergency research participation. Experience with the exception from informed consent (EFIC) to facilitate clinical trials on potentially life-saving emergency interventions is limited in the United States. Here, we share our experience of EFIC utilization in the recently completed prospective multi-center randomized comparative-effectiveness clinical trial of Sedation versus General Anesthesia (SEGA) in AIS endovascular thrombectomy (EVT), (Clinical Trial ID: NCT03263117).

Methods We conducted in-person community consultations and a social media campaign on Facebook within a 50-mile radius of the Texas Medical Center. A website for the SEGA trial was created and a press release was issued with trial information. Voluntary survey information was collected. While EFIC was successfully approved for the trial at the leading center, many other participating centers were unable to pursue EFIC approval due to lack of existing guidelines and extremely limited information for proper EFIC approval. The enrollment rate, pace, door-to-needle time, incidence of subject drop-outs, and COVID lockdown impact were compared between the centers utilizing EFIC and the enrollment with the traditional consent process.

Results Among 260 patients enrolled in SEGA, 63% of patients were enrolled via EFIC. Enrolment rate was greatest at the EFIC center compared to non-EFIC (63% vs 37%, patients/month, EFIC vs. non EFIC, p<0.05). Enrollment rate did not decrease during the COVID time period. The details of door-to-groin time, the incidence of subject drop-out in the EFIC enrolled group, and the impact on the SEGA study will be presented at SNIS.

Conclusion Methods and guidance on EFIC for acute stroke clinical trials have not been well established in United States. We present the SEGA trial experience to propel modernization of national guidelines for EFIC and improve future acute stroke trial recruitment.

Disclosures P.Chen: 1; C;Stryker, Balt. C. Artime: None. S. Sheth: None. C. Pedroza: None. E. Aguilar: None. T. Nguyen: None. A. Sanzgiri: None. S. Sridhar: None. A. Barreto: None.

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