Endoscopic Intraventricular Hematoma Evacuation Surgery Versus EVD for IVH

NCT ID: NCT04037267

Last Updated: 2019-07-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 956 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2022-09-01

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.

Conditions

Intraventricular Hemorrhage, Endoscopic Intraventricular Evacuation Surgery, Extraventricular Drainage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endoscopic Treatment

Endoscopy was performed using a rigid endoscope. The hematoma was removed by a technique using irrigation and aspiration. The ventricular drainage catheter was placed on the surgical side. Six hours after surgery, we administered 20,000 U urokinase with 5 ml saline every 8 hours through the catheter and the catheter was closed for 1 hour to allow drug-clot interaction and then reopened to allow for gravitational drainage. Subsequent CT scans were done for any safety concern or every 24 hours. Administration of urokinase was stopped when the CT scans showed that the circulation of cerebrospinal fluid is unobstructed. When CT scans showed that the intracerebral hematoma was significantly reduced and the circulation of cerebrospinal fluid is unobstructed, the catheter could be clamped for 24 h. If there was no acute intracranial pressure increase, the catheter could then be removed.

Group Type: EXPERIMENTAL

endoscopic intraventricular evacuation surgery

Intervention Type: PROCEDURE

According to the discussion between the patient and the doctor, the patient signed the consent form and voluntarily enrolled and subsequently the patient was included in the endoscopic intraventricular evacuation surgery group.

EVD Treatment

The surgeons used a soft catheter to puncture in depth of about 5 cm. The next step was to fix the drainage catheter. Postoperative CT was done immediately to confirm positioning of the soft catheter and stability of the hematoma. Six hours or more after catheter placement, we administered 20,000 U urokinase with 5 ml saline every 8 hours and the catheter was closed for 1 h to allow drug-clot interaction and then reopened to allow for gravitational drainage. Subsequent CT scans were done for any safety concern or every 24 hours. Administration of urokinase was stopped when the CT scans showed that the circulation of cerebrospinal fluid is unobstructed. When CT scans showed that the intracerebral hematoma was significantly reduced and the circulation of cerebrospinal fluid is unobstructed, the catheter could be clamped for 24 h. If there was no acute intracranial pressure increase, the catheter could then be removed.

Group Type: ACTIVE_COMPARATOR

endoscopic intraventricular evacuation surgery

Intervention Type: PROCEDURE

According to the discussion between the patient and the doctor, the patient signed the consent form and voluntarily enrolled and subsequently the patient was included in the endoscopic intraventricular evacuation surgery group.

Interventions

endoscopic intraventricular evacuation surgery

According to the discussion between the patient and the doctor, the patient signed the consent form and voluntarily enrolled and subsequently the patient was included in the endoscopic intraventricular evacuation surgery group.

Intervention Type: PROCEDURE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gao Tao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jinling Hospital

Nanjing, Jiangsu, China

Countries

China

References

Zhu J, Tang C, Cong Z, Yang J, Cai X, Liu Y, Ma C. Endoscopic intraventricular hematoma evacuation surgery versus external ventricular drainage for the treatment of patients with moderate to severe intraventricular hemorrhage: a multicenter, randomized, controlled trial. Trials. 2020 Jul 13;21(1):640. doi: 10.1186/s13063-020-04560-3.

Reference Type: DERIVED

PMID: 32660530 (View on PubMed)

Other Identifiers

2019NZKY-014-01

Identifier Type: -

Identifier Source: org_study_id