NCT02995928

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 19, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

May 4, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

May 10, 2017

Status Verified

March 1, 2017

Enrollment Period

11 months

First QC Date

November 27, 2016

Last Update Submit

May 9, 2017

Conditions

Subarachnoid Hemorrhage, Aneurysmal

Keywords

Subarachnoid HemorrhageDecompressive CraniectomyCerebral Aneurysm

Outcome Measures

Primary Outcomes (1)

  • Modified Rankin scale (mRS)

    By phone call following-up by senior neurosurgeons

    180 days post SAH

Secondary Outcomes (7)

  • Modified Rankin scale (mRS)

    30 days and 90 days post SAH

  • Glosgow Coma Score (GCS)

    24 hours postoperation

  • Incidence of delayed cerebral ischemia

    30 days post SAH

  • Incidence of herniation

    30 days post SAH

  • Incidence of cerebral vasospasm

    30 days post SAH

  • +2 more secondary outcomes

Study Arms (2)

Decompressive craniectomy

EXPERIMENTAL

Decompressive craniectomy and best medical treatment

Procedure: Decompressive craniectomyProcedure: Best medical treatment

Control

ACTIVE COMPARATOR

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

Interventions

Decompressive craniectomyPROCEDURE

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.

Decompressive craniectomy
Best medical treatmentPROCEDURE

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.

ControlDecompressive craniectomy

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tandu Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710038, China

RECRUITING

Related Publications (6)

  • 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.

    PMID: 18946217BACKGROUND

  • 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.

    PMID: 24514267BACKGROUND

  • 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.

    PMID: 25400113BACKGROUND

  • 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.

    PMID: 21492596BACKGROUND

  • 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.

    PMID: 17272765BACKGROUND

  • 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.

    PMID: 25817570BACKGROUND

MeSH Terms

Conditions

Subarachnoid HemorrhageIntracranial Aneurysm

Interventions

Decompressive Craniectomy

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntracranial Arterial DiseasesAneurysm

Intervention Hierarchy (Ancestors)

Decompression, SurgicalSurgical Procedures, OperativeCraniotomyNeurosurgical Procedures

Central Study Contacts

Yan Qu, M.D Ph.D

CONTACT

86-18629074363yanqu0123@icloud.com

Min Li, M.D Ph.D

CONTACT

86-15319053136neursylm@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2016

First Posted

December 19, 2016

Study Start

May 4, 2017

Primary Completion

April 1, 2018

Study Completion

July 1, 2018

Last Updated

May 10, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)