Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cardiac Function in Severe Aneurysmal Subarachnoid Haemorrhage Patients (SPLASH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01801800
Recruitment Status : Completed
First Posted : March 1, 2013
Last Update Posted : May 12, 2014
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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
Aneurysmal Subarachnoid Haemorrhage World Neurosurgeon Federation Score ≥ III 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

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
Official Title: Speckle Tracking Assessment of Cardiac Function in Severe Aneurysmal Subarachnoid Haemorrhage and Impact on Neurologic Outcome (SPLASH)
Study Start Date : January 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Group/Cohort 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




Primary Outcome Measures :
  1. Neurologic outcome [ Time Frame: 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 [ Time Frame: Day 1 ]
  2. Correlation between cardiac enzymes (NT-proBNP, troponin T US) and cardiac strain [ Time Frame: Day 1 ]
  3. Correlation between EKG findings and cardiac strain [ Time Frame: Day 1 ]
  4. Time to amines discontinuation [ Time Frame: During Intensive Care Unit stay, expected average 17 days ]
  5. Duration of mechanical ventilation [ Time Frame: Duration of mechanical ventilation, expected average 15 days ]
  6. Length of ICU stay [ Time Frame: Duration of ICU stay, expected average 17 days ]
  7. Correlation between Cardiac function and Mechanical Ventilation [ Time Frame: Day1, day3, day7 and extubation time expected average 15 days ]
  8. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Severe Aneurysmal subarachnoid haemorrhage
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01801800


Locations
Layout table for location information
France
University Hospital
Nantes, France, 44000
University Hospital
Rennes, France, 35000
Sponsors and Collaborators
Nantes University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Raphael Cinotti, MD Nantes University Hospital
Study Chair: Bertrand ROZEC, PhD, MD Nantes University Hospital

Additional Information:

Publications:
Layout table for additonal information
Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01801800     History of Changes
Other Study ID Numbers: RC12_0410
First Posted: March 1, 2013    Key Record Dates
Last Update Posted: May 12, 2014
Last Verified: May 2014
Keywords provided by Nantes University Hospital:
Aneurysmal subarachnoid haemorrhage
Additional relevant MeSH terms:
Layout table for MeSH terms
Subarachnoid Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases