Recruitment of Patients during the Pandemic in Interact3 Trial: Indian Experience

ABSTRACT

Background and Aims: The case fatality rate of acute spontaneous intracerebral hemorrhage (ICH) is high 54% at 1 year, and only 12% to 39% of survivors achieve long term functional independence. The INTEnsive care bundle with blood pressure Reduction in Acute Cerebral haemorrhage Trial (INTERACT3) was an international, multicentre, cluster-randomized clinical trial to assess a multifaceted goal-directed care bundle of physiological management in patients with acute ICH. We aimed to study the challenges encountered in recruitment during the pandemics in India. Method(s) Between August 2020 and October 2022, all adult patients presenting with spontaneous ICH within 6 hours from symptom onset were enrolled under the standard of usual care management until they are informed of crossing over to intervention and to be contacted at 6 months follow-up. Result(s) Six out of ten screened centres participated. The pandemic posed many challenges to the recruitment of patients in the trial The ethics committee meetings were interrupted, preventing us enrolling more sites. Fewer patients presented to hospital due to fear of covid, economic crisis, transportation barriers, delayed presentation beyond 6 hours due to poor triaging, delay in RTPCR testing, slow referrals, unwillingness to followup in outpatient clinic. Solutions frequent virtual meetings with ethics committees were held by site PIs, RTPCR switched to rapid testing, ER physicians trained to rapidly identify ICH cases and trial strategy was modified at each centre to boost recruitment. Conclusion(s) Alternative approaches for rapid triaging and modified strategies to recruitment are needed to overcome challenges of implementing a stroke trial during a pandemic.