Endoscopic Intraventricular Hematoma Evacuation Surgery Versus EVD for IVH

Not Applicable

• Conditions: Intraventricular Hemorrhage, Endoscopic Intraventricular Evacuation Surgery, Extraventricular Drainage

• Registration Number: NCT04037267
• Lead Sponsor: Nanjing PLA General Hospital

Brief Summary

Intraventricular hemorrhage (IVH) accounts for about 20% of intracerebral hemorrhage, but its mortality rate is as high as 50%-80%. External ventricular drainage (EVD) can rapidly reduce intracranial pressure, but clinical practice found that drainage catheters are often blocked by blood clots and long-term thrombolytic therapy is likely to cause secondary bleeding. The application of neuroendoscopy in IVH has attracted more and more attention in recent years. Studies have shown that the use of neuroendoscopy for IVH evacuation (with EVD) has advantages over EVD alone. However, the cases of most current research are small and all of them are retrospective studies, which means lacking prospective clinical studies to provide high-quality evidence. Based on this, we intend to conduct a randomized, controlled, multi-center clinical trial to compare the prognosis of patients who undergo endoscopic IVH evacuation surgery versus those who undergo external ventricular drainage for moderate to severe IVH.

Detailed Description

Spontaneous Intraventricular hemorrhage (IVH) is defined as bleeding into the cerebral ventricular system caused by spontaneous rupture of brain arteries, veins and capillaries instead of trauma. IVH accounts for about 20% of cerebral hemorrhage, but its mortality rate is as high as 50%-80%. According to the results of the STICH trial, the prognosis of patients with IVH is worse than that of patients without IVH (p\<0.00001); if patients with IVH have hydrocephalus, the prognosis is the worst.

According to the edition of 2015 Chinese multidisciplinary experts' consensus for spontaneous cerebral hemorrhage diagnosis and treatment and 2015 AHA/ASA spontaneous cerebral hemorrhage diagnosis and treatment guidelines, for patients with small amount of IVH without obstructive hydrocephalus, conservative treatment or continuous lumbar drainage can be effective. For patients with large amount of IVH (hematoma occupying more than 50% of the lateral ventricle, secondary obstructive hydrocephalus or obviously increased intracranial pressure), the occupancy effect is dramatic and patients are prone to suffering from hydrocephalus and cerebral palsy, in which circumstances urgent evacuation of hematoma is required, but it is controversial whether it is beneficial for the patients and whether it can improve the prognosis of patients.

As the regular treatment for IVH, external ventricular drainage (EVD) can rapidly reduce intracranial pressure, but clinical practice found that drainage catheters are often blocked by blood clots, and long-term thrombolytic therapy is likely to cause secondary bleeding. Usually, the catheters need to be removed or replaced one week after placement as for the increasing risk of infection.

The application of endoscopy in IVH has attracted more and more attention. Studies have shown that the use of endoscopy for IVH evacuation (with EVD) has advantages over EVD alone. The incidence of postoperative hydrocephalus and the need for ventricular-peritoneal shunt surgery is lower. However, the cases of most current research are small and all of them are retrospective studies. There are no such clinical trials registered at home and abroad, and that is, there is a lack of prospective high-quality clinical studies to further demonstrate the effect of endoscopic treatment for IVH.

Based on this, we intend to conduct a randomized, controlled, multi-center clinical trial to compare the prognosis of patients who undergo endoscopic IVH evacuation surgery versus those who undergo external ventricular drainage for moderate to severe IVH.

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-26
• Study First Submitted QC: 2019-07-26
• Last Update Submitted: 2019-07-26
• Study First Posted: 2019-07-30
• Last Update Posted: 2019-07-30
• Study Start: 2019-09-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 956

Inclusion Criteria

• 1. Age ranging from 18 to 70 years old; 2. Imaging examination shows deep brain hemorrhage breaking into the ventricles or primary intraventricular hemorrhage, and the amount of bleeding is large, more than 50% of the lateral ventricle or complete ventricle cast; 3. Graeb score > 4 points; 4. Voluntary signing of informed consent;

Exclusion Criteria

• 1. Patients with a history of chronic obstructive pulmonary disease, coronary heart disease, chronic kidney disease, blood disorders, cancer, systemic autoimmune disease, or long-term oral corticosteroids; 2. Imaging examination shows cerebellum and brain stem hemorrhage; 3. Detected cerebrovascular diseases in CTA/MRA/MRV/DSA examinations (choose 1 or 2 examinations); 4. Ultra-early (within 72 hours) or late enhanced MRI suggests the presence of brain tumors; 5. Coagulopathy or long-term oral anticoagulant;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Survival of patients at 12 months postoperatively	12 months

Secondary Outcome Measures

Name	Time	Method
Hospitalization expenses	0-12 month	Hospitalization expenses
Modified Rankin score	preoperative, one month, three months, six months, twelve months	Modified Rankin score
Hospital stay	0-12 month	Hospital stay
Proportion of patients who need ventricular-peritoneal shunt Incidence of postoperative hydrocephalus	0-12 month	Proportion of patients who need ventricular-peritoneal shunt Incidence of postoperative hydrocephalus
Incidence of postoperative intracranial infection	0-12 month	Incidence of postoperative intracranial infection

Trial Locations

Locations (1)

Jinling Hospital; 🇨🇳 Nanjing, Jiangsu, China