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

Primary Purpose

Subarachnoid Hemorrhage, Aneurysmal

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Decompressive craniectomy
Best medical treatment
Sponsored by
Tang-Du Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subarachnoid Hemorrhage, Aneurysmal focused on measuring Subarachnoid Hemorrhage, Decompressive Craniectomy, Cerebral Aneurysm

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tandu Hospital, Fourth Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Decompressive craniectomy

Control

Arm Description

Decompressive craniectomy and best medical treatment

Only best medical treatment. Decompressive craniectomy is employed only if intracranial pressure >25 mm Hg for 1-12 hours to keep the patients safe.

Outcomes

Primary Outcome Measures

Modified Rankin scale (mRS)
By phone call following-up by senior neurosurgeons

Secondary Outcome Measures

Modified Rankin scale (mRS)
By phone call following-up by senior neurosurgeons
Glosgow Coma Score (GCS)
Assessing by senior neurosurgeons
Incidence of delayed cerebral ischemia
Proved by clinical and radiologic evidence
Incidence of herniation
Proved by clinical and radiologic evidence
Incidence of cerebral vasospasm
Proved by clinical and radiologic evidence
Incidence of rebleeding
Proved by clinical and radiologic evidence
Death

Full Information

First Posted
November 27, 2016
Last Updated
May 9, 2017
Sponsor
Tang-Du Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02995928
Brief Title
Trial of Prophylactic Decompressive Craniectomy for Poor-grade Aneurysmal Subarachnoid Hemorrhage
Official Title
Trial of Prophylactic Decompressive Craniectomy for Poor-grade Aneurysmal Subarachnoid Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 4, 2017 (Actual)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tang-Du Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage, Aneurysmal
Keywords
Subarachnoid Hemorrhage, Decompressive Craniectomy, Cerebral Aneurysm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Decompressive craniectomy
Arm Type
Experimental
Arm Description
Decompressive craniectomy and best medical treatment
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Only best medical treatment. Decompressive craniectomy is employed only if intracranial pressure >25 mm Hg for 1-12 hours to keep the patients safe.
Intervention Type
Procedure
Intervention Name(s)
Decompressive craniectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Best medical treatment
Intervention Description
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 Measure Information:
Title
Modified Rankin scale (mRS)
Description
By phone call following-up by senior neurosurgeons
Time Frame
180 days post SAH
Secondary Outcome Measure Information:
Title
Modified Rankin scale (mRS)
Description
By phone call following-up by senior neurosurgeons
Time Frame
30 days and 90 days post SAH
Title
Glosgow Coma Score (GCS)
Description
Assessing by senior neurosurgeons
Time Frame
24 hours postoperation
Title
Incidence of delayed cerebral ischemia
Description
Proved by clinical and radiologic evidence
Time Frame
30 days post SAH
Title
Incidence of herniation
Description
Proved by clinical and radiologic evidence
Time Frame
30 days post SAH
Title
Incidence of cerebral vasospasm
Description
Proved by clinical and radiologic evidence
Time Frame
30 days post SAH
Title
Incidence of rebleeding
Description
Proved by clinical and radiologic evidence
Time Frame
30 days post SAH
Title
Death
Time Frame
30 days post SAH

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Qu, M.D Ph.D
Phone
86-18629074363
Email
yanqu0123@icloud.com
First Name & Middle Initial & Last Name or Official Title & Degree
Min Li, M.D Ph.D
Phone
86-15319053136
Email
neursylm@163.com
Facility Information:
Facility Name
Tandu Hospital, Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Qu, M.D Ph.D
Phone
86-18629074363
Email
yanqu0123@icloud.com
First Name & Middle Initial & Last Name & Degree
Min Li, M.D Ph.D
Phone
86-15319053136
Email
neursylm@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18946217
Citation
Otani N, Takasato Y, Masaoka H, Hayakawa T, Yoshino Y, Yatsushige H, Miyawaki H, Sumiyoshi K, Chikashi A, Takeuchi S, Suzuki G. Surgical outcome following decompressive craniectomy for poor-grade aneurysmal subarachnoid hemorrhage in patients with associated massive intracerebral or Sylvian hematomas. Cerebrovasc Dis. 2008;26(6):612-7. doi: 10.1159/000165115. Epub 2008 Oct 23.
Results Reference
background
PubMed Identifier
24514267
Citation
Uozumi Y, Sakowitz O, Orakcioglu B, Santos E, Kentar M, Haux D, Unterberg A. Decompressive craniectomy in patients with aneurysmal subarachnoid hemorrhage: a single-center matched-pair analysis. Cerebrovasc Dis. 2014;37(2):109-15. doi: 10.1159/000356979. Epub 2014 Feb 7.
Results Reference
background
PubMed Identifier
25400113
Citation
Lu X, Huang B, Zheng J, Tao Y, Yu W, Tang L, Zhu R, Li S, Li L. Decompressive craniectomy for the treatment of malignant infarction of the middle cerebral artery. Sci Rep. 2014 Nov 17;4:7070. doi: 10.1038/srep07070.
Results Reference
background
PubMed Identifier
21492596
Citation
Dorfer C, Frick A, Knosp E, Gruber A. Decompressive hemicraniectomy after aneurysmal subarachnoid hemorrhage. World Neurosurg. 2010 Oct-Nov;74(4-5):465-71. doi: 10.1016/j.wneu.2010.08.001. Epub 2011 Jan 12.
Results Reference
background
PubMed Identifier
17272765
Citation
Schirmer CM, Hoit DA, Malek AM. Decompressive hemicraniectomy for the treatment of intractable intracranial hypertension after aneurysmal subarachnoid hemorrhage. Stroke. 2007 Mar;38(3):987-92. doi: 10.1161/01.STR.0000257962.58269.e2. Epub 2007 Feb 1.
Results Reference
background
PubMed Identifier
25817570
Citation
Zhao B, Zhao Y, Tan X, Cao Y, Wu J, Zhong M, Wang S. Primary decompressive craniectomy for poor-grade middle cerebral artery aneurysms with associated intracerebral hemorrhage. Clin Neurol Neurosurg. 2015 Jun;133:1-5. doi: 10.1016/j.clineuro.2015.03.009. Epub 2015 Mar 14.
Results Reference
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Trial of Prophylactic Decompressive Craniectomy for Poor-grade Aneurysmal Subarachnoid Hemorrhage

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