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SPLASH: Cardiac Function in Severe Aneurysmal Subarachnoid Haemorrhage Patients

Sponsor
Nantes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01801800
Collaborator
(none)
80
Enrollment
2
Locations
23
Duration (Months)
40
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Echocardiography

Detailed Description

Trans-thoracic echocardiography on day 1, day 3 and day 7 Speckle-Tracking of echocardiographic loops by a cardiologist blinded to the patient's management and outcome

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Speckle Tracking Assessment of Cardiac Function in Severe Aneurysmal Subarachnoid Haemorrhage and Impact on Neurologic Outcome (SPLASH)
Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Aneurysmal subarachnoid haemorrhage

Speckle-tracking images in Echocardiography

Procedure: Echocardiography
Speckle-Tracking of echocardiographic loops by a cardiologist blinded to the patient's management and outcome

Outcome Measures

Primary Outcome Measures

  1. Neurologic outcome [3 months]

    modified Rankin Scale (mRS). Poor neurological outcome was considered as death or severe disability (mRS 5-6).

Secondary Outcome Measures

  1. Correlation between cardiac strain on day 1 and Left Ventricular Ejection fraction [Day 1]

  2. Correlation between cardiac enzymes (NT-proBNP, troponin T US) and cardiac strain [Day 1]

  3. Correlation between EKG findings and cardiac strain [Day 1]

  4. Time to amines discontinuation [During Intensive Care Unit stay, expected average 17 days]

  5. Duration of mechanical ventilation [Duration of mechanical ventilation, expected average 15 days]

  6. Length of ICU stay [Duration of ICU stay, expected average 17 days]

  7. Correlation between Cardiac function and Mechanical Ventilation [Day1, day3, day7 and extubation time expected average 15 days]

  8. Correlation between Cardiac function and ICU length of stay [Day1, day3, day 7 and end of stay in ICU expected average 17 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Nantes France 44000
2 University Hospital Rennes France 35000

Sponsors and Collaborators

  • Nantes University Hospital

Investigators

  • Principal Investigator: Raphael Cinotti, MD, Nantes University Hospital
  • Study Chair: Bertrand ROZEC, PhD, MD, Nantes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01801800
Other Study ID Numbers:
  • RC12_0410
First Posted:
Mar 1, 2013
Last Update Posted:
May 12, 2014
Last Verified:
May 1, 2014
Keywords provided by Nantes University Hospital
Aneurysmal subarachnoid haemorrhage
Additional relevant MeSH terms:
Subarachnoid Hemorrhage
Hemorrhage

Study Results

No Results Posted as of May 12, 2014