Minimally Invasive Neurosurgery With Al-assisted Robotic Guidance for BrainStem Hemorrhage Within a Multicenter, Randomized, Controlled, Umbrella Trial (RAINBOW-BSH)

NANot yet recruitingINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Brain Stem HemorrhageRobotic Surgical ProceduresStereotactic Techniques
Interventions
PROCEDURE

Robot-Assisted Stereotactic Brainstem Hematoma Puncture

Positioning and surgical procedures are carried out based on the use of robotic navigation equipment. Precise preoperative design is conducted using preoperative imaging data to create a preoperative three-dimensional visualization model. During surgery, robot-assisted stereotactic puncture is performed. First day, urokinase may be used as needed to assist in dissolving residual hematoma and adjusting the depth of the drainage tube. For every 10 mL of hematoma, 1 mL of 10,000 IU urokinase in 0.9% sodium chloride solution is injected, followed by flushing with 2 mL of 0.9% sodium chloride solution through the tube after closing it for 2 hours, and then reopening it. Urokinase injections into the drainage tube are used 1-2 times daily to facilitate hematoma drainage. Third day, if the residual hematoma volume is \<3 mL or if the drainage tube has been in place for \>5 days, the drainage tube is removed.

DRUG

Conservative non-surgical treatment

Oxygen therapy, intensive care, maintaining stable blood pressure (targeting 140/90 mmHg), sedation, intracranial pressure control, arousal promotion, gastric protection, maintaining homeostasis, infection control, neurological nutrition, brain function improvement, nutritional support, general condition improvement, and other treatments are provided. For comatose patients, ensuring airway patency, administering nebulized expectorants, preventing respiratory depression, improving respiratory function, and performing tracheostomy if necessary are part of the care plan. Close monitoring of patients' conditions and proactive symptomatic treatment are prioritized. Regular follow-up cranial CT scans are scheduled to monitor intracranial conditions. Ventricular puncture drainage is considered if there is concomitant intraventricular hemorrhage or obstructive hydrocephalus (with patient consent).

Trial Locations (3)

100029

China-Japan Friendship Hospital, Beijing

100049

Aerospace Center Hospital, Beijing

100190

Hebei Provincial People's Hospital, Shijiazhuang

All Listed Sponsors
lead

Yanbing Yu

OTHER

NCT06459427 - Minimally Invasive Neurosurgery With Al-assisted Robotic Guidance for BrainStem Hemorrhage Within a Multicenter, Randomized, Controlled, Umbrella Trial (RAINBOW-BSH) | Biotech Hunter | Biotech Hunter