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

Subarachnoid Hemorrhage, Aneurysmal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02995928
• Other study ID #: TDSJWKDC
• Status: Recruiting
• Phase: N/A
• First received: November 27, 2016
• Last updated: May 9, 2017
• Start date: May 4, 2017
• Est. completion date: July 2018

Study information

• Verified date: March 2017
• Source: Tang-Du Hospital
• Contact: Yan Qu, M.D Ph.D
• Phone: 86-18629074363
• Email: yanqu0123[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage, Aneurysmal

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Tandu Hospital, Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View 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. — View 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. — View 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. Epub 2007 Feb 1. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin scale (mRS)	By phone call following-up by senior neurosurgeons	180 days post SAH
Secondary	Modified Rankin scale (mRS)	By phone call following-up by senior neurosurgeons	30 days and 90 days post SAH
Secondary	Glosgow Coma Score (GCS)	Assessing by senior neurosurgeons	24 hours postoperation
Secondary	Incidence of delayed cerebral ischemia	Proved by clinical and radiologic evidence	30 days post SAH
Secondary	Incidence of herniation	Proved by clinical and radiologic evidence	30 days post SAH
Secondary	Incidence of cerebral vasospasm	Proved by clinical and radiologic evidence	30 days post SAH
Secondary	Incidence of rebleeding	Proved by clinical and radiologic evidence	30 days post SAH
Secondary	Death		30 days post SAH