Trial of Prophylactic Decompressive Craniectomy for Poor-grade Aneurysmal Subarachnoid Hemorrhage

May 9, 2017 updated by: Tang-Du Hospital
Decompressive craniectomy has been reported for the treatment of patients with aneurysmal subarachnoid hemorrhage (aSAH). 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 combine aneurysm clipping surgery or endovascular coiling will improve clinical outcomes of poor-grade aSAH patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Aneurysmal subarachnoid hemorrhage (aSAH) is a worldwide health burden with high fatality and permanent disability rates. Decompressive craniectomy, which is beneficial in patients with malignant middle cerebral artery infarction, may indirectly relieve the mass effect, decrease perihematomal tissue pressure, improve blood flow, reduce secondary brain damage and improve outcome without further damage to the brain due to surgery. Early therapy with either surgical clipping or neuroradiologic intervention with endovascular coiling is the primary treatment for aSAH. But whether decompressive craniectomy should be employed during the clipping surgery or immediately after coil embolization still have considerable controversy. 80 patients will be recruited to the trial over 12 months. Follow-up will take 6 months with analysis and reporting taking 6 months.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Recruiting
        • Tandu Hospital, Fourth Military Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age>18yrs and age<60yrs
  • It shows subarachnoid hemorrhage (SAH) based on computed tomography (CT) scan on admission
  • Aneurysmal subarachnoid hemorrhage confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA) or digital subtraction angiography (DSA)
  • Presentation to our institution in World Federation of Neurological Societies (WFNS) Grade III to V neurological condition with Lateral hematoma
  • Duration from onset to admission is within 48 hours

Exclusion Criteria:

  • Traumatic subarachnoid hemorrhage
  • Patients with cerebral herniation or highly possible to occur before surgery
  • Neurosurgery contraindicated
  • Patients with obvious evidence of acute hydrocephalus on admission
  • Intracranial aneurysm combined with cerebral arteriovenous malformation
  • Patients with obvious evidence of irreparable brainstem or thalamic injury
  • Duration from onset to admission is more than 48 hours
  • Disturbance of communication or poor compliance to blood collection, imageological examination and follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Decompressive craniectomy
Decompressive craniectomy and best medical treatment
Procedure: Decompressive craniectomy
Decompressive craniectomy: All patients in the treatment group will receive decompressive craniectomy of at least 12 cm according to institutional guidelines and a published surgical protocol during the clipping surgery within 48 hours form the onset.
Procedure: Best medical treatment
Best medical treatment: Best medical treatment is based on American Heart Association/American Stroke Association (AHA/ASA) and European Stroke Organisation (ESO) as published in the current protocol from 2012 and 2013 respectively.
Active Comparator: Control
Only best medical treatment. Decompressive craniectomy is employed only if intracranial pressure >25 mm Hg for 1-12 hours to keep the patients safe.
Procedure: Best medical treatment
Best medical treatment: Best medical treatment is based on American Heart Association/American Stroke Association (AHA/ASA) and European Stroke Organisation (ESO) as published in the current protocol from 2012 and 2013 respectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin scale (mRS)
Time Frame: 180 days post SAH
By phone call following-up by senior neurosurgeons
180 days post SAH

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin scale (mRS)
Time Frame: 30 days and 90 days post SAH
By phone call following-up by senior neurosurgeons
30 days and 90 days post SAH
Glosgow Coma Score (GCS)
Time Frame: 24 hours postoperation
Assessing by senior neurosurgeons
24 hours postoperation
Incidence of delayed cerebral ischemia
Time Frame: 30 days post SAH
Proved by clinical and radiologic evidence
30 days post SAH
Incidence of herniation
Time Frame: 30 days post SAH
Proved by clinical and radiologic evidence
30 days post SAH
Incidence of cerebral vasospasm
Time Frame: 30 days post SAH
Proved by clinical and radiologic evidence
30 days post SAH
Incidence of rebleeding
Time Frame: 30 days post SAH
Proved by clinical and radiologic evidence
30 days post SAH
Death
Time Frame: 30 days post SAH
30 days post SAH

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tang-Du Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2017

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

November 27, 2016

First Submitted That Met QC Criteria

December 14, 2016

First Posted (Estimate)

December 19, 2016

Study Record Updates

Last Update Posted (Actual)

May 10, 2017

Last Update Submitted That Met QC Criteria

May 9, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDSJWKDC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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