Minimally invasive puncture and drainage combined with urokinase in the treatment of spontaneous intracerebral hemorrhage in the basal ganglia (MIPDU): A multicenter randomized controlled trial protocol

Spontaneous intracerebral hemorrhage (ICH) represents a severe subtype of stroke with a notably high incidence, particularly in China, where it constitutes 21%-48% of cerebrovascular events. This condition predominantly affects the elderly population and is linked to high rates of mortality and disability. Key risk factors include hypertension, cerebral amyloid angiopathy, and the use of anticoagulants. Despite advancements in management strategies, such as blood pressure regulation and prevention of hematoma expansion, the treatment of ICH remains a formidable challenge. Minimally invasive puncture and drainage (MIPD) has demonstrated potential in enhancing patient outcomes by facilitating hematoma evacuation and reducing intracranial pressure. However, the results are still inconclusive, especially concerning hemorrhages in the basal ganglia.

This study aims to evaluate the efficacy of combining MIPD with urokinase in comparison to conservative management for basal ganglia ICH.

Method/Design: This multicenter, randomized controlled trial aims to assess the efficacy of minimally invasive puncture and drainage (MIPD) with urokinase compared to conservative management in patients with basal ganglia intracerebral hemorrhage (ICH) across ten neurosurgical centers in China.

Inclusion Criteria: The study will enroll 140 participants aged 18-80 years, who present with a Glasgow Coma Scale (GCS) score ranging from 4 to 14, a National Institutes of Health Stroke Scale (NIHSS) score of 6 or higher, and a hematoma volume between 20 and 40 mL.

Randomization Method: All participants are randomly assigned to groups using the simple randomization method. Randomization will be stratified by center to ensure balanced distribution across sites.

Interventions: Participants in the intervention group will receive MIPD with urokinase within 48 h of symptom onset, while those in the control group will undergo conservative management.

Outcome Measures: The primary outcomes to be measured are mortality and functional disability, assessed using the GCS, modified Rankin Scale (mRS), and NIHSS, at 3090 days and 180 days postintervention. Secondary outcomes will include neurological recovery, rates of complications, and incidence of rebleeding.

Funding: This trial is supported in The National Natural Science Foundation of China (NSFC) Youth Project (NSFC-82101424) and Middleaged and Young Leading Talents in Scientific and Technical Innovation in Ankang (AK2023PD-ZQN-5).