A nationwide, multicenter clinical study
TIME-ICH is a multicenter, randomized, adaptive clinical trial evaluating the efficacy and safety of early minimally invasive catheter evacuation with thrombolysis (eMIST), in addition to best medical management, for acute spontaneous supratentorial intracerebral hemorrhage.
EXPLORE THE STUDY
TIME IS BRAIN The Data and Safety Monitoring Board (DSMB) held its first online meeting, chaired by Prof. Peter Kan of the University of Texas Medical Branch. Principal Investigator Prof. Tao Hong presented the study design and the data and safety monitoring plan. Voting members Prof. Lu Ma, Prof. Qi Li, Prof. Ping Zhang and Prof. Chengbei Hou reviewed the safety endpoints and monitoring triggers, and voted to approve the protocol, clearing the study to begin enrollment.
The TIME-ICH kickoff meeting and investigator training session was held during CFITN 2025 in Changzhou, Jiangsu. Investigators from 42 research centers completed systematic training on the protocol, workflow and image-guided catheter placement, marking the study’s official move into implementation.
Xuanwu Hospital, Capital Medical University enrolled the study’s first participant, officially opening recruitment across the nationwide network.
Investigators from 28 participating centers gathered in Beijing. Prof. Tao Hong and Prof. Ye Li reported overall progress, and Dr. Shaohua Mo presented key implementation points and the quality control system. Roundtable discussions addressed enrollment challenges such as the treatment time window, family communication, in-hospital workflow and follow-up management, setting the goal of completing enrollment for the 250-case interim analysis in 2026.
The meeting reported steady progress: 717 patients screened and 65 enrolled nationwide, reaching 26% of the 250-case target for the first interim analysis with 100% follow-up completion. The team aligned operational standards on urokinase dosing intervals, blood pressure management, puncture trajectory and aspiration principles, and centers shared strategies for common bottlenecks such as the time window and patient treatment preferences.
Chaired by Prof. Peter Kan of the University of Texas Medical Branch, the second DSMB meeting reviewed recruitment progress, protocol adherence and safety events from ongoing enrollment. Voting members Prof. Lu Ma, Prof. Qi Li, Prof. Ping Zhang and Prof. Chengbei Hou unanimously approved the trial to continue as planned, with the next regular meeting tentatively scheduled for October 2026.
Prof. Urs Fischer, member of the study’s international advisory committee, President of the European Stroke Organisation and Chair of Neurology at the University Hospital of Bern, visited Xuanwu Hospital. He received a progress update on TIME-ICH, toured the China International Neuroscience Institute, and delivered the lecture “Surgical approaches in intracerebral haemorrhage” hosted by Prof. Tao Hong.
The meeting reviewed overall progress: as of June 30, 2026, 59 centers had been activated, with 959 patients screened and 123 enrolled, putting the first interim analysis nearly halfway to target with 100% follow-up completion. Drawing on feedback from 38 centers, the team analyzed enrollment bottlenecks and agreed on improvements in screening workflow, time window management and informed consent, followed by open discussion among centers.
The Global Burden of Disease study highlights marked international variation in intracerebral hemorrhage incidence.
Global Burden of Disease Study 2019.Despite major advances in modern medicine over the past three decades that have markedly reduced ischemic stroke mortality, outcomes for patients with intracerebral hemorrhage have remained largely stagnant.
Stroke Vasc Neurol., 2020; Neurology, 2021The study tests whether early catheter evacuation with urokinase (eMIST), added to best medical management, improves 180-day functional outcome compared with best medical management alone.
Global Burden of Disease Study 2019.
Intracerebral hemorrhage remains one of the most devastating forms of stroke. Over the past three decades, case fatality of ischemic stroke has fallen markedly, while outcomes after hemorrhagic stroke have barely improved. In China, reported incidence and mortality are among the highest worldwide, and long-term disability remains common.
Whether surgical hematoma evacuation helps—and how early it should be performed—remains unresolved. How early treatment can begin, and how minimally invasive it can remain, are still unknown. This open question is the starting point of TIME-ICH.
Landmark trials have progressively refined patient selection, surgical approach, and treatment timing in intracerebral hemorrhage. TIME-ICH extends this trajectory into the ultra-early window.
In adults with acute spontaneous supratentorial ICH, can early catheter evacuation with urokinase, added to best medical management, improve 180-day functional outcome without compromising safety?
Population
Intervention
Comparison
Outcomes
01 Three-dimensional CT reconstruction delineates hematoma geometry to plan a catheter path that avoids critical vascular structures and eloquent brain regions.
02 A catheter placed along the hematoma long axis achieves targeted decompression via a narrow corridor, relieving mass effect while minimizing tissue injury.
03 With serial CT monitoring, urokinase is instilled following a standardized protocol until target hematoma reduction is achieved, ensuring safe and timely catheter removal.
Baseline imaging, neurological assessment, laboratory evaluation, medical history, and informed consent.
eMIST group receives catheter drainage and thrombolysis;
Control group receives best medical management.
Neurological status, imaging, laboratory findings, procedural metrics, and adverse events.
Functional outcomes, activities of daily living, quality of life, rehabilitation and safety.
Participating centers operate on a unified platform featuring centralized randomization, core-lab imaging adjudication, and shared data management.
Spanning 25 provinces to ensure broad population representativeness, the network serves as a nationwide collaborative platform for intracerebral hemorrhage research.
