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

NCT02995928 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-05-10

No results posted yet for this study

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.

Conditions

  • Subarachnoid Hemorrhage, Aneurysmal

Interventions

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.

Sponsors & Collaborators

  • Tang-Du Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-04
Primary Completion
2018-04-30
Completion
2018-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02995928 on ClinicalTrials.gov