Endoscopic Intraventricular Hematoma Evacuation Surgery Versus EVD for IVH

NCT04037267 | Unknown

• 1 other identifier: 2019NZKY-014-01
• Study Type: interventional
• Target: 956
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraventricular Hemorrhage, Endoscopic Intraventricular Evacuation Surgery, Extraventricular Drainage

Outcome Measures

Primary Outcomes (1)

• Survival of patients at 12 months postoperatively

  12 months

Secondary Outcomes (5)

• Modified Rankin score

  preoperative, one month, three months, six months, twelve months

• Proportion of patients who need ventricular-peritoneal shunt Incidence of postoperative hydrocephalus

  0-12 month

• Incidence of postoperative intracranial infection

  0-12 month

• Hospital stay

  0-12 month

• Hospitalization expenses

  0-12 month

Study Arms (2)

Endoscopic Treatment

EXPERIMENTAL

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.

Procedure: endoscopic intraventricular evacuation surgery

EVD Treatment

ACTIVE COMPARATOR

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.

Procedure: endoscopic intraventricular evacuation surgery

Interventions

endoscopic intraventricular evacuation surgery 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; Endoscopic Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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;

You may not qualify if:

• \. 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;

Sponsors & Collaborators

• Nanjing PLA General Hospital: lead

Study Sites (1)

Jinling Hospital

Nanjing, Jiangsu, 210002, China

Location

Related Publications (1)

• 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.

  PMID: 32660530 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: July 30, 2019
• Study Start: September 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: September 1, 2022
• Last Updated: July 30, 2019

Record last verified: 2019-07

Locations

CN (1)