FINAL RESULTS OF THE REPERFUSION WITH COOLING IN CEREBRAL ACUTE ISCHEMIA II TRIAL (RECCLAIM II)
Recommended Citation
Gupta R, Hout TK, Sun C, Yoo A, Zaidi S, Zaidat O, Chebl AB, Badjatia N, Al-Bayati A, Horn C. FINAL RESULTS OF THE REPERFUSION WITH COOLING IN CEREBRAL ACUTE ISCHEMIA II TRIAL (RECCLAIM II). European Stroke Journal 2024; 9(1):655.
Document Type
Conference Proceeding
Publication Date
5-1-2024
Publication Title
European Stroke Journal
Keywords
adult, aged, brain hemorrhage, cerebrovascular accident, clinical article, conference abstract, controlled study, cooling, female, human, hypothermia, infarct volume, major clinical study, male, mechanical thrombectomy, multicenter study, National Institutes of Health Stroke Scale, pneumonia, randomized controlled trial, reperfusion, side effect, thrombectomy
Abstract
Background and aims: Hypothermia reduces ischemic injury in preclinical stroke models. We hypothesized combining systemic cooling with mechanical thrombectomy(MT) is safe, feasible without delaying reperfusion. Methods: Ten sites in the United States enrolled patients in a prospective, randomized core lab adjudicated study to determine the safety of systemic hypothermia to 33 degrees C for six hours with MT. Patients with MCA or ICA occlusion with an ASPECT score of more than 5 under 24 hours from onset were included. The trial was terminated at 66 (planned 80) patients due to catheter supply chain issues. The primary end point compared door to reperfusion time in both groups and secondary endpoint of final infarct volume. Results: Between May 2019-October 2023 and a total of 95 patients were enrolled (29 lead-in phase and 66 randomized). The mean age of the randomized cohort was 65±12 years with a median NIHSS of 15. The mean time to reach a target temperature was 9±3.7 minutes with 29 of 33 (87.8%) patients achieving target temperature of 34 degrees C within one hour. There was no difference in the time from arrival to first pass between the cooling group 86.2±38.7 minutes vs. 84.2±32 minutes in the control group (p=0.74). There was a trend towards lower final infarct volume in the treatment group with a mean infarct of 31.2±46.6 cc compared to 55.7±68.5 cc (p<0.13). There were no differences in intracranial hemorrhages or pneumonia rates. Conclusions: Systemic hypothermia does not delay care of thrombectomy patients and can be performed safely.
Volume
9
Issue
1
First Page
655
