Decompressive Craniectomy Combined With Hematoma Removal to Treat ICH

Intracranial Hemorrhages Clinical Trial

— CARICH  

Official title:

A Randomised Trial to Establish the Efficacy and Safety of Decompressive Craniectomy Combined With Hematoma Removal in Patients With Intracerebral Hemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02135783
• Other study ID #: Neurosurg 01
• Status: Recruiting
• Phase: N/A
• First received: May 7, 2014
• Last updated: February 4, 2016
• Start date: October 2014
• Est. completion date: October 2018

Study information

• Verified date: February 2016
• Source: Southwest Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Intracerebral hemorrhage (ICH) is one of the most serious subtypes of stroke, affecting approximately 2-3 million people worldwide each year. About one third of people with ICH die early after onset and the majority of survivors are left with major long-term disability. Hematoma removal (HR) surgery is the primary treatment for ICH which volume is more than 30ml. But whether decompressive craniectomy (DC) should be employed during the HR surgery still has considerable controversy. Outcomes in this study will be measured at 3 months after surgery via a postal questionnaire including the Glasgow Outcome scale, Modified Rankin Scale, and Barthel index. Two hundred patients will be recruited to the trial over 36 months. Follow-up will take three months with analysis and reporting taking one year.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Intracranial Hemorrhages

Intervention

Procedure:
• Decompressive Craniectomy
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.
• non-Decompressive Craniectomy
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.

Locations

Country	Name	City	State
China	Department of Neurosurgery , Southwest Hospital, Third Military Medical University,	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality and disability	according to a 3-6 scores on the modified Rankin Score	3 months	No
Secondary	Occurrence of second Surgery		72 hours	Yes