Abstract P132: Successful Conduct of an Acute Stroke Clinical Trial During COVID

Abstract

Introduction: Most clinical research stopped during COVID due to possible impact on data quality and personnel safety. We aimed to assess the impact of COVID on study conduct at sites that continued to enroll patients during the pandemic. Methods: BEST-MSU is an ongoing study of Mobile Stroke Units (MSU) vs standard management of tPA eligible acute stroke patients in the pre-hospital setting. MSU personnel include a vascular neurologist via telemedicine, and a nurse, CT tech, and medics on board using appropriate PPE. During COVID, consent, 90 d mRS and EQ5D could be obtained by phone instead of in person, otherwise management was the same. We compared patient demographics, study metrics, and infection of study personnel during intra- vs pre-COVID eras. Results: Four of 6 BEST-MSU sites continued to enroll during COVID. There was no difference in intra- (n= 41) vs pre- (n= 763) COVID enrolled tPA eligible patients’ age, sex, race (45% vs 41% Black), ethnicity (23% vs 19% Hispanic), or NIHSS (12 vs 12). MSU alert frequency did not change, but percent of screened patients enrolled and treated with tPA declined to 12% from 23% (p<.001); enrollment correlated with local stay at home and reopening (fig). There was no difference in alert to MSU arrival or arrival to tPA times, but on-scene time was 2 min longer (p=.04). There was no difference in ED door to CT, tPA, or EVT times, hospital LOS, discharge disposition, or 90d mRS or EQ5D accuracy. One MSU nurse tested positive but did not require medical care. Conclusion: Clinical research in the pre-hospital setting can be carried out accurately and safely during a pandemic. Study enrollment and tPA treatment rates declined, but otherwise there was no difference in patient demographics, deterioration of study processes, or serious infection of study staff.

Optimization of sensitivity and specificity of a biomarker-based blood test (LVOCheck-Opti): A protocol for a multicenter prospective observational study of patients suspected of having a stroke

“…These units provide timely and efficient stroke care to patients by bringing the expertise and resources of the hospital directly to the patient's location. The use of MSUs has been shown to reduce the alarm-to-treatment time (ATT), increase the number of patients treated in the first hour after symptom onset, and improve functional outcomes compared to regular care (3)(4)(5)(6)(7)(8)(9)(10). In Berlin, MSUs have been in operation since 2011 as special vehicles of the Berlin Fire Department (Stroke Emergency Mobiles, STEMO).…”

Prospective collection of blood plasma samples to identify potential biomarkers for the prehospital stroke diagnosis (ProGrEss-Bio): study protocol for a multicenter prospective observational study

“…Mobile stroke units (MSUs)-ambulances with a CT scanner and a point-of-care (POC) laboratory on board-significantly reduce the alarm-to-treatment time (ATT) compared to regular care and increase the number of patients treated within 60 min after the onset of symptoms (11)(12)(13)(14), two large studies (Berlin_PRehospital Or Usual Delivery of Acute Stroke Care (B_PROUD) and BEnefits of Stroke Treatment Delivered Using a Mobile Stroke Unit [BEST-MSU]) independently demonstrated that treatment on board an MSU led to a significant reduction in disability at 90 days (15,16). Furthermore, in cases of large vessel occlusion (LVO), patients can be selectively transported to the next appropriate hospital offering mechanical thrombectomy.…”