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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01801800 |
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Date of registration:
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15/02/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cardiac Function in Severe Aneurysmal Subarachnoid Haemorrhage Patients
SPLASH |
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Scientific title:
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Speckle Tracking Assessment of Cardiac Function in Severe Aneurysmal Subarachnoid Haemorrhage and Impact on Neurologic Outcome (SPLASH) |
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Date of first enrolment:
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January 2012 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01801800 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Bertrand ROZEC, PhD, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Nantes University Hospital |
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Name:
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Raphael Cinotti, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Nantes University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Aneurysmal subarachnoid haemorrhage
- World Neurosurgeon Federation Score = III
- Written information to next-of-kin and patients when possible
Exclusion Criteria:
- History of myocardial infarction, chronic heart failure with NYHA = 2, major heart
surgery
- Lack of acoustic window to perform trans-thoracic echocardiography
Age minimum:
15 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Aneurysmal Subarachnoid Haemorrhage
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World Neurosurgeon Federation Score = III
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Intervention(s)
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Procedure: Echocardiography
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Primary Outcome(s)
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Neurologic outcome
[Time Frame: 3 months]
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Secondary Outcome(s)
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Time to amines discontinuation
[Time Frame: During Intensive Care Unit stay, expected average 17 days]
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Correlation between Cardiac function and Mechanical Ventilation
[Time Frame: Day1, day3, day7 and extubation time expected average 15 days]
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Length of ICU stay
[Time Frame: Duration of ICU stay, expected average 17 days]
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Correlation between EKG findings and cardiac strain
[Time Frame: Day 1]
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Correlation between cardiac strain on day 1 and Left Ventricular Ejection fraction
[Time Frame: Day 1]
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Correlation between Cardiac function and ICU length of stay
[Time Frame: Day1, day3, day 7 and end of stay in ICU expected average 17 days]
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Correlation between cardiac enzymes (NT-proBNP, troponin T US) and cardiac strain
[Time Frame: Day 1]
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Duration of mechanical ventilation
[Time Frame: Duration of mechanical ventilation, expected average 15 days]
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Secondary ID(s)
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RC12_0410
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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