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Completed

NCT Number: NCT01801800

Cardiac Function in Severe Aneurysmal Subarachnoid Haemorrhage Patients

Cardiac dysfunction can occur in aneurysmal subarachnoid haemorrhage and might impact patient's neurologic outcome Condition Aneurysmal subarachnoid haemorrhage World Neurosurgeon Federation Score ≥ III

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Key information

Conditions

Aneurysmal Subarachnoid Haemorrhage World Neurosurgeon Federation Score ≥ III

Age range

15 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, Nantes, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echocardiography

Procedure

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Speckle Tracking Assessment of Cardiac Function in Severe Aneurysmal Subarachnoid Haemorrhage and Impact on Neurologic Outcome (SPLASH)

Acronym: SPLASH

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 1, 2013
Registry last updated
May 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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