The outcomes of combined endoscopic surgery and fibrinolytic treatment protocol for intraventricular hemorrhage

Phase 4

• Conditions: spontaneous intraventricular hemorrhagesecondary intraventricular hemorrhage from spontaneous intracerebral hemorhageobstructive hydrocephalus; intraventricular hemorrhage; hydrocephalus; fibrinolytic agent; endoscopic removal

• Registration Number: TCTR20191122002
• Lead Sponsor: /A

Brief Summary

This study demonstrated that combined ES and IVF is safe and effective for the treatment of IVH. In addition, it concluded that aggressive but safe procedures used to remove IVH could improve clinical outcome in patients with IVH.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-22
• Study Completion: 2021-11-28
• Results First Posted: 2023-01-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Terminated (Halted Prematurely)
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. age 18-80 years
2. onset less than 24 hours prior to CT brain
3. primary intraventricular hemorrhage or secondary from spontaneous intracerebral hemorrhage less than 20 ml
4. obstructive hydrocephalus from blood clot in 3rd or 4th ventricles
5. SBP < 200 mmHg or MAP <130 mmHg prior to treatment
6. Modified Rankin Scale 0 or 1 before onset

Exclusion Criteria

1. Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moya-moya disease disease or tumor
2. previous brain surgery less than 3 months
3. uncorrectable bleeding disorders, platelet count less than 100,000, or INR more than 1.3
4. pregnancy
5. infratentorium hemorrhage
6. severe unstable medical conditions such as uncontrolled cardiac disease
7. subjects refuse to participate, unidentifiable subject, or unable to find consent for subject

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale (mRS) Posttreatment 6 month mRS 0-3 vs 0-6

Secondary Outcome Measures

Name	Time	Method
Modified Rankin Scale (mRS) Posttreatment 3 month mRS 0-3 vs 0-6,Mortality rate entire study mortality event,Quality of life Posttreatment 1, 3 and 6month EQ 5D 5L,Rate of shunt surgery entire study event of shunt surgery,Complications entire study complication event rate