Evaluation on Fufang Congrong Yizhi Capsules (FCYC) of cognitive impairment after robot-assisted neurosurgery treatment for intracerebral hemorrhage (CONPAIR) : study protocol for a randomized controlled trial

Background Intracerebral hemorrhage (ICH) is associated with high mortality and disability rates, which places a significant social burden. Robot-assisted neurosurgery with precise positioning and high stability has become an important advance in the development of minimally invasive surgery for ICH. Cognitive impairment is a common complication in patients with ICH, which seriously affects the stroke rehabilitation process. We are not sure about the medication treatment for cognitive impairment after robot-assisted neurosurgery treatment for ICH. In this CONPAIR trial, we will evaluate the safety and efficacy of Fufang Congrong Yizhi Capsules (FCYC) for cognitive impairment after robot-assisted neurosurgery treatment for ICH. Methods and analysis In this multicentrer, randomized, controlled trial involving patients with cognitive impairment after robot-assisted neurosurgery treatment for ICH, we assessed medical management. Two hundred patients will be randomly assigned, in a 1:1 ratio, to either an experimental group or a control group. The experimental group will receive conventional treatment and oral administration of FCYC for 12 weeks or the control group will receive only conventional treatment. The primary safety end point was death within 30 days after enrollment. Ethics and management The Case Report Form (CRF) will be completed and signed by well-trained researchers. We will monitor and promptly report adverse events throughout the trial. The privacy and data of the subjects will be safeguarded. Research Ethics Board approval has been obtained. ClinicalTrials.gov number NCT06673602