NCT04037267

Endoscopic Intraventricular Hematoma Evacuation Surgery Versus EVD for IVH

Status unknown NA Last updated 30 July 2019

What this trial tests

NA trial testing endoscopic intraventricular evacuation surgery in Intraventricular Hemorrhage, Endoscopic Intraventricular Evacuation Surgery, Extraventricular Drainage in 956 participants. Status unknown.

Timeline

1 September 2019

Primary endpoint
31 December 2021

1 September 2022

Quick facts

Lead sponsor	Nanjing PLA General Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	956
Start date	1 September 2019
Primary completion	31 December 2021
Estimated completion	1 September 2022
Sites	1 location across China

Drugs / interventions tested

• endoscopic intraventricular evacuation surgery

Conditions studied

• Intraventricular Hemorrhage, Endoscopic Intraventricular Evacuation Surgery, Extraventricular Drainage — all drugs for Intraventricular Hemorrhage, Endoscopic Intraventricular Evacuation Surgery, Extraventricular Drainage →

Sponsor

Nanjing PLA General Hospital

Who can join

Adults 18 to 70, any sex, with Intraventricular Hemorrhage, Endoscopic Intraventricular Evacuation Surgery, Extraventricular Drainage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Zhu J, Tang C, Cong Z, Yang J, et al · · 2020 · cited 10× · PMID 32660530 · DOI 10.1186/s13063-020-04560-3
2. Randomized Clinical Trials in Cerebrovascular Neurosurgery From 2018 to 2022.
   Kappel AD, Nguyen HB, Frerichs KU, Patel NJ, et al · · 2024 · PMID 38361699 · DOI 10.7759/cureus.52397
3. 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
   Zhu J, Tang C, Cong Z, Yang J, et al · · 2020 · DOI 10.21203/rs.2.16570/v3