“ReCCLAIM I”: endovascular reperfusion and hypothermia for severe ischemic stroke
Horn et al. report a prospective Phase I trial to assess hypothermia in severe cerebral infarction patients treated with mechanical thrombectomy. Although preclinical studies showed improved outcomes with hypothermia, clinical studies performed on a heterogeneous patient population failed to show benefit; mechanical thrombectomy patients were not previously studied with hypothermia. Inclusion criteria were: age 18-85, ASPECT Score 5-7, M1/M2 or ICA terminus occlusion, presentation <8h, and NIHSS>13. 22 severe symptomatic stroke patients who received mechanical thrombectomy followed by central intravenous cooling to 33°C for 12 hours were compared to 68 historical control patients. Positive findings included similar pneumonia rates and significantly lower intracranial hemorrhage rates in hypothermia patients (15% vs 50%, p<0.01). No significant outcome difference in discharge to acute rehab or modified Rankin score was found. Study limitations included historical control bias, a higher percentage of patients in the solitaire and penumbra treatment arm, variable hypothermia duration, andrestriction to severe stroke. Authors concluded that hypothermia’s safety and feasibility in severe stroke patients was demonstrated and proposed a Phase IIrandomized control trial.