NCT02135783

Brief Summary

Decompressive craniectomy has been reported for the treatment of patients with intracerebral hemorrhage. But no prospective randomised controlled trials have yet been undertaken to confirm its effect.The purpose of the study is to determine whether decompressive craniectomy post hematoma removal surgery after intracerebral hemorrhage will reduce the chances of a person dying or surviving with a long term disability.

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
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

May 7, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

February 5, 2016

Status Verified

February 1, 2016

Enrollment Period

3 years

First QC Date

May 7, 2014

Last Update Submit

February 4, 2016

Conditions

Intracranial Hemorrhages

Outcome Measures

Primary Outcomes (1)

  • Mortality and disability

    according to a 3-6 scores on the modified Rankin Score

    3 months

Secondary Outcomes (1)

  • Occurrence of second Surgery

    72 hours

Study Arms (2)

Decompressive Craniectomy

EXPERIMENTAL

Decompressive Craniectomy afte Hematoma Removal in Patients with Intracerebral Hemorrhage

Procedure: Decompressive Craniectomy

non-Decompressive Craniectomy

ACTIVE COMPARATOR

non-Decompressive Craniectomy afte Hematoma Removal in Patients with Intracerebral Hemorrhage

Procedure: non-Decompressive Craniectomy

Interventions

Decompressive CraniectomyPROCEDURE

A portion of frontal,temporal, and parietal bone was removed by craniectomy and the size of decompression was about 10x12 cm2.Intracerebral hematoma was evacuated by transcortical approach with the aid of a surgical microscope.

Decompressive Craniectomy
non-Decompressive CraniectomyPROCEDURE

a simple hematoma removal by osteoplastic craniotomy group (HR) or Intracerebral hematoma was evacuated by transcortical approach with the aid of a surgical neuroendoscopyand the size of decompression was about 3x2.5 cm2.

non-Decompressive Craniectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Evidence of a spontaneous lobar and basal ganglia ICH on CT scan
  • Patient within 72 hours of ictus
  • Best score on the GCS of 5-13.
  • Volume of hematoma between 30 and 100ml \[Calculated using (a x b x c)/2 method\]
  • The history of hypertensive

You may not qualify if:

  • Clear evidence that the hemorrhage is due to an aneurysm or angiographically proven arteriovenous malformation.
  • Intraventricular hemorrhage of any sort
  • ICH secondary to tumour or trauma.
  • If the hematological effects of any previous anticoagulants are not completely reversed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery , Southwest Hospital, Third Military Medical University,

Chongqing, China

RECRUITING

Related Publications (2)

  • Zhang C, Zhang S, Yin Y, Wang L, Li L, Lan C, Shi J, Jiang Z, Ge H, Li X, Ao Z, Hu S, Chen J, Feng H, Hu R. Clot removAl with or without decompRessive craniectomy under ICP monitoring for supratentorial IntraCerebral Hemorrhage (CARICH): a randomized controlled trial. Int J Surg. 2024 Aug 1;110(8):4804-4809. doi: 10.1097/JS9.0000000000001466.

    PMID: 38640513DERIVED

  • Hu R, Zhang C, Xia J, Ge H, Zhong J, Fang X, Zou Y, Lan C, Li L, Feng H. Long-term Outcomes and Risk Factors Related to Hydrocephalus After Intracerebral Hemorrhage. Transl Stroke Res. 2021 Feb;12(1):31-38. doi: 10.1007/s12975-020-00823-y. Epub 2020 Jun 8.

    PMID: 32514905DERIVED

MeSH Terms

Conditions

Intracranial Hemorrhages

Interventions

Decompressive Craniectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Decompression, SurgicalSurgical Procedures, OperativeCraniotomyNeurosurgical Procedures

Study Officials

  • Rong Hu, MD,PhD

    Department of Neurosurgery, Southwest Hospital

    PRINCIPAL INVESTIGATOR

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
Associate Professor

Study Record Dates

First Submitted

May 7, 2014

First Posted

May 12, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2017

Study Completion

October 1, 2018

Last Updated

February 5, 2016

Record last verified: 2016-02

Locations

CN(1)