Early Lumbar Drainage Combined With Intrathecal Urokinase Injection for Treatment of Severe Aneurysmal SAH (LD-ITUK)

Launched by SECOND AFFILIATED HOSPITAL OF NANCHANG UNIVERSITY · Feb 21, 2024

Keywords

ClinConnect Summary

The LD-ITUK clinical trial is studying a new approach to treat patients with severe aneurysmal subarachnoid hemorrhage (aSAH), which is a type of bleeding in the brain caused by a burst blood vessel. In this trial, eligible participants will be randomly assigned to either receive the standard treatment along with a special injection of a medication called urokinase, or to receive a placebo (a harmless substance with no active medication). The goal is to see if this combination treatment improves recovery and function after six months, compared to the standard care alone.

To be eligible for the trial, participants must be at least 18 years old and experiencing their first episode of aSAH. They should not have undergone any brain surgery before the trial and must have a specific level of illness severity. Participants will receive the treatment within 24 hours of their aneurysm being treated and will be monitored closely for six months to assess their recovery. This trial is important because it could offer new insights into improving outcomes for patients with this serious condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient's age ≥ 18 years
• • First occurrence of aneurysmal subarachnoid hemorrhage
• • Patients without any craniotomy treatment before onset
• • Hunt-Hess grade III-V
• • mRS grade 0 or 1 before onset
• • Aneurysm treatment within 48 hours of onset
• • Informed consent given by the subject or guardian
• Exclusion Criteria:
• • Subarachnoid hemorrhage caused by arteriovenous malformation or moyamoya disease or other cerebrovascular disease
• • Patients requiring craniotomy to remove intracranial hematoma
• • modified Fisher Scale grade 0
• • Prothrombin time (PT) and activated partial thromboplastin time (APTT) are greater than 2 times the extended range
• • Absolute contraindications for lumbar puncture (e.g., brain hernia, puncture site infection)
• • Patients with a life expectancy of less than 1 year due to other causes
• • Other concomitant serious diseases that are difficult to treat;
• • Pregnant woman
• • Patients who were known to be allergic to urokinase and excipients or had a history of severe allergy and were deemed unsuitable for inclusion by the investigators
• • Participated in another interventional clinical trial within 30 days before randomization
• • Other reasons deemed unsuitable for study participation by the investigator