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Decompressive Craniectomy Combined With Hematoma Removal to Treat ICH (CARICH)

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ClinicalTrials.gov Identifier: NCT02135783
Recruitment Status : Unknown
Verified February 2016 by Rong Hu, Southwest Hospital, China.
Recruitment status was:  Recruiting
First Posted : May 12, 2014
Last Update Posted : February 5, 2016
Sponsor:
Information provided by (Responsible Party):
Rong Hu, Southwest Hospital, China

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.

Condition or disease Intervention/treatment Phase
Intracranial Hemorrhages Procedure: Decompressive Craniectomy Procedure: non-Decompressive Craniectomy Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Trial to Establish the Efficacy and Safety of Decompressive Craniectomy Combined With Hematoma Removal in Patients With Intracerebral Hemorrhage
Study Start Date : October 2014
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Decompressive Craniectomy
Decompressive Craniectomy afte Hematoma Removal in Patients with Intracerebral Hemorrhage
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.

Active Comparator: non-Decompressive Craniectomy
non-Decompressive Craniectomy afte Hematoma Removal in Patients with Intracerebral Hemorrhage
Procedure: 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.




Primary Outcome Measures :
  1. Mortality and disability [ Time Frame: 3 months ]
    according to a 3-6 scores on the modified Rankin Score


Secondary Outcome Measures :
  1. Occurrence of second Surgery [ Time Frame: 72 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135783


Locations
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China
Department of Neurosurgery , Southwest Hospital, Third Military Medical University, Recruiting
Chongqing, China
Contact: Rong Hu, MD    +8615123917123    huchrong@aliyun.com   
Principal Investigator: Rong Hu, MD PHD         
Sponsors and Collaborators
Southwest Hospital, China
Investigators
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Principal Investigator: Rong Hu, MD,PhD Department of Neurosurgery, Southwest Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rong Hu, Associate Professor, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT02135783    
Other Study ID Numbers: Neurosurg 01
First Posted: May 12, 2014    Key Record Dates
Last Update Posted: February 5, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Intracranial Hemorrhages
Hemorrhage
Hematoma
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases