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Effect and safety of early lumbar drainage combined with intrathecal urokinase injection for treatment of poor-grade aneurysmal subarachnoid hemorrhage: multicentral randomized control trial

Effect and safety of early lumbar drainage combined with intrathecal urokinase injection for treatment of poor-grade aneurysmal subarachnoid hemorrhage: multicentral randomized control trial - LDITUK

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080583
Enrollment
Unknown
Registered
2024-02-01
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysmal subarachnoid hemorrhage

Interventions

LDITUK group:Standard treatment+lumbar cistern drainage+intrathecal urokinase injection
control group:Standard treatment+lumbar cistern drainage

Sponsors

The Second Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion 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

Exclusion criteria: - Subarachnoid hemorrhage caused by arteriovenous malformation or moyamoya disease or other cerebrovascular disease - modified Fisher Scale grade 0 - Prothrombin time (PT) and activated partial thromboplastin time (APTT) are less 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

Design outcomes

Primary

MeasureTime frame
mRS score of 0~2;

Secondary

MeasureTime frame
mRS score of 0~6;Cerebral vasospasm incidence;Delayed cerebral ischemia incidence;All-cause mortality;Shunt dependent hydrocephalus incidence;Aneurysm rerupture incidence;Length of stay;Hospitalization expenses;mRS score of 0~2 Rates;

Countries

China

Contacts

Public ContactXingen Zhu

The Second Affiliated Hospital of Nanchang University

zxg2008vip@163.com+86 138 0354 6020

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026