Cardiac Function in Severe Aneurysmal Subarachnoid Haemorrhage Patients
SPLASH
Speckle Tracking Assessment of Cardiac Function in Severe Aneurysmal Subarachnoid Haemorrhage and Impact on Neurologic Outcome (SPLASH)
1 other identifier
observational
80
1 country
2
Brief Summary
Cardiac dysfunction can occur in aneurysmal subarachnoid haemorrhage and might impact patient's neurologic outcome Condition Aneurysmal subarachnoid haemorrhage World Neurosurgeon Federation Score ≥ III
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2012
2 active sites
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
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 15, 2013
CompletedFirst Posted
Study publicly available on registry
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMay 12, 2014
May 1, 2014
1.9 years
February 15, 2013
May 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neurologic outcome
modified Rankin Scale (mRS). Poor neurological outcome was considered as death or severe disability (mRS 5-6).
3 months
Secondary Outcomes (8)
Correlation between cardiac strain on day 1 and Left Ventricular Ejection fraction
Day 1
Correlation between cardiac enzymes (NT-proBNP, troponin T US) and cardiac strain
Day 1
Correlation between EKG findings and cardiac strain
Day 1
Time to amines discontinuation
During Intensive Care Unit stay, expected average 17 days
Duration of mechanical ventilation
Duration of mechanical ventilation, expected average 15 days
- +3 more secondary outcomes
Study Arms (1)
Aneurysmal subarachnoid haemorrhage
Speckle-tracking images in Echocardiography
Interventions
Speckle-Tracking of echocardiographic loops by a cardiologist blinded to the patient's management and outcome
Eligibility Criteria
Severe Aneurysmal subarachnoid haemorrhage
You may qualify if:
- Aneurysmal subarachnoid haemorrhage
- World Neurosurgeon Federation Score ≥ III
- Written information to next-of-kin and patients when possible
You may not qualify if:
- History of myocardial infarction, chronic heart failure with NYHA ≥ 2, major heart surgery
- Lack of acoustic window to perform trans-thoracic echocardiography
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Hospital
Nantes, 44000, France
University Hospital
Rennes, 35000, France
Related Publications (1)
Hofmeijer J, Kappelle LJ, Algra A, Amelink GJ, van Gijn J, van der Worp HB; HAMLET investigators. Surgical decompression for space-occupying cerebral infarction (the Hemicraniectomy After Middle Cerebral Artery infarction with Life-threatening Edema Trial [HAMLET]): a multicentre, open, randomised trial. Lancet Neurol. 2009 Apr;8(4):326-33. doi: 10.1016/S1474-4422(09)70047-X. Epub 2009 Mar 5.
PMID: 19269254BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Raphael Cinotti, MD
Nantes University Hospital
- STUDY CHAIR
Bertrand ROZEC, PhD, MD
Nantes University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2013
First Posted
March 1, 2013
Study Start
January 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
May 12, 2014
Record last verified: 2014-05