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

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ClinicalTrials.gov Identifier: NCT02995928
Recruitment Status : Unknown
Verified March 2017 by Tang-Du Hospital.
Recruitment status was:  Recruiting
First Posted : December 19, 2016
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
Tang-Du Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage, Aneurysmal Procedure: Decompressive craniectomy Procedure: Best medical treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trial of Prophylactic Decompressive Craniectomy for Poor-grade Aneurysmal Subarachnoid Hemorrhage
Actual Study Start Date : May 4, 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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.




Primary Outcome Measures :
  1. Modified Rankin scale (mRS) [ Time Frame: 180 days post SAH ]
    By phone call following-up by senior neurosurgeons


Secondary Outcome Measures :
  1. Modified Rankin scale (mRS) [ Time Frame: 30 days and 90 days post SAH ]
    By phone call following-up by senior neurosurgeons

  2. Glosgow Coma Score (GCS) [ Time Frame: 24 hours postoperation ]
    Assessing by senior neurosurgeons

  3. Incidence of delayed cerebral ischemia [ Time Frame: 30 days post SAH ]
    Proved by clinical and radiologic evidence

  4. Incidence of herniation [ Time Frame: 30 days post SAH ]
    Proved by clinical and radiologic evidence

  5. Incidence of cerebral vasospasm [ Time Frame: 30 days post SAH ]
    Proved by clinical and radiologic evidence

  6. Incidence of rebleeding [ Time Frame: 30 days post SAH ]
    Proved by clinical and radiologic evidence

  7. Death [ Time Frame: 30 days post SAH ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02995928


Contacts
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Contact: Yan Qu, M.D Ph.D 86-18629074363 yanqu0123@icloud.com
Contact: Min Li, M.D Ph.D 86-15319053136 neursylm@163.com

Locations
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China, Shaanxi
Tandu Hospital, Fourth Military Medical University Recruiting
Xi'an, Shaanxi, China, 710038
Contact: Yan Qu, M.D Ph.D    86-18629074363    yanqu0123@icloud.com   
Contact: Min Li, M.D Ph.D    86-15319053136    neursylm@163.com   
Sponsors and Collaborators
Tang-Du Hospital

Publications:

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Responsible Party: Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT02995928     History of Changes
Other Study ID Numbers: TDSJWKDC
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tang-Du Hospital:
Subarachnoid Hemorrhage
Decompressive Craniectomy
Cerebral Aneurysm

Additional relevant MeSH terms:
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Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases