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New treatment option for Aneurysmal Subarachnoid Hemorrhage
Official title Early Lumbar Drainage Plus Intrathecal Urokinase in Severe Aneurysmal Subarachnoid Hemorrhage (LD-ITUK)
ClinicalTrials.gov ID: NCT06284642
What this study is testing
What is Urokinase?
Urokinase is an investigational medicine, given as an once-daily injectable medicine, being studied as a potential treatment for aneurysmal subarachnoid hemorrhage.
Also referred to as Urokinase-type plasminogen activator.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The LD-ITUK is a multicenter, prospective, randomized, double-blind, blind endpoint, placebo-control design trial. All eligible patients with the diagnosis of severe aSAH will be randomly assigned to the treatment group or the placebo group.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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 treatment clinical trial within 30 days before randomization
- Other reasons deemed unsuitable for study participation by the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Heihe, Anhui, China
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Wuxi, Jiangsu, China
- Ganzhou, Jiangxi, China
- Nanchang, Jiangxi, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Heihe, Anhui, China; Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Harbin, Heilongjiang, China; Zhengzhou, Henan, China and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.