NCT02515903

Brief Summary

Views for surgery method selection of intracerebral hemorrhage are still controversial. Since the application of neuroendoscopic technique in intraventricular hemorrhage was confirmed effective and safe, some investigators have attempted to use endoscopic strategies to evacuate intracerebral hematomas. Some significant advances have also been reported in endoscopic hematoma evacuation when compared to conventional craniotomy. However, it is still crucial to implement a prospective and controlled study to evaluate the efficiency and safety of endoscopic technique in the treatment of intracerebral hemorrhage. In this study, the investigators will exclusively select some patients with intracerebral hemorrhage in the basal ganglia region. This study will compare the efficacy and safety of endoscopic surgery versus stereotactic aspiration on neurologic outcomes for patients with intracerebral hemorrhage.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 5, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

August 5, 2015

Status Verified

August 1, 2015

Enrollment Period

1 year

First QC Date

July 22, 2015

Last Update Submit

August 2, 2015

Conditions

Intracerebral HemorrhageSurgery

Keywords

EndoscopyIntracerebral hemorrhagesurgerystereotactic aspirationKey-hole approachIntracerebral hemorrhage surgical treatmentTransparent endoscopic sheathAgitation-aspiration device

Outcome Measures

Primary Outcomes (1)

  • Mortality rate

    all-cause motality rate within 90 days after the surgery

    90-day

Secondary Outcomes (8)

  • operative time

    24 h

  • days of ICU stay

    14 day

  • remnant blood in the hematoma after surgery

    12 hour

  • Glasgow coma score

    28 day

  • Glasgow outcome score

    90-day

  • +3 more secondary outcomes

Study Arms (2)

Intra-endoscopy

EXPERIMENTAL

This intervention arm will receive intra-endoscopic evacuation surgery for ICH.

Procedure: Intra-endoscopic surgery

Stereotactic Aspiration

PLACEBO COMPARATOR

This arm will receive stereotactic aspiration surgery for ICH evacuation.

Procedure: Placebo:stereotactic aspiration surgery

Interventions

Intra-endoscopic surgeryPROCEDURE

Intra-endoscopic surgery for evacuation of ICH

Intra-endoscopy
Placebo:stereotactic aspiration surgeryPROCEDURE

Placebo:stereotactic aspiration surgery for evacuation of ICH

Stereotactic Aspiration

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary basal ganglion region intracerebral hemorrhage
  • older than 18 years
  • admitted within 6 h after onset of ICH

You may not qualify if:

  • other type of ICH than acute primary intracerebral hemorrhage
  • patients who need neurosurgery
  • life expectancy less than 3 months due to comorbid disorders
  • confirmed malignant disease (cancer)
  • confirmed acute myocardial infarction
  • hepatitis and/liver cirrhosis
  • renal failure
  • infectious disease (HIV, endocarditis etc.)
  • current or previous hematologic disease
  • women of childbearing age if pregnant
  • participation in another study within the preceding 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital of Southern University

Guangzhou, Guangdong, 518000, China

RECRUITING

Related Publications (3)

  • Du B, Xu J, Hu J, Zhong X, Liang J, Lei P, Wang H, Li W, Peng Y, Shan A, Zhang Y. A Clinical Study of the Intra-Neuroendoscopic Technique for the Treatment of Subacute-Chronic and Chronic Septal Subdural Hematoma. Front Neurol. 2020 Jan 17;10:1408. doi: 10.3389/fneur.2019.01408. eCollection 2019.

    PMID: 32010057DERIVED

  • Zhang Y, Shan AJ, Peng YP, Lei P, Xu J, Zhong X, Du B. The intra-neuroendoscopic technique (INET): a modified minimally invasive technique for evacuation of brain parenchyma hematomas. World J Emerg Surg. 2019 May 6;14:21. doi: 10.1186/s13017-019-0239-0. eCollection 2019.

    PMID: 31080494DERIVED

  • Du B, Shan AJ, Zhang YJ, Wang J, Peng KW, Zhong XL, Peng YP. The intra-neuroendoscopic technique: A new method for rapid removal of acute severe intraventricular hematoma. Neural Regen Res. 2018 Jun;13(6):999-1006. doi: 10.4103/1673-5374.233442.

    PMID: 29926826DERIVED

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Bo Du, MD

CONTACT

86-13823699011ftipa@163.com

Yu-ping Peng, MD

CONTACT

86-1591414197983936462@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2015

First Posted

August 5, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2016

Study Completion

November 1, 2016

Last Updated

August 5, 2015

Record last verified: 2015-08

Locations

CN(1)