Cardiac Function in Severe Aneurysmal Subarachnoid Haemorrhage Patients

Aneurysmal Subarachnoid Haemorrhage Clinical Trial

— SPLASH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801800
• Other study ID #: RC12_0410
• Status: Completed
• Phase: N/A
• First received: February 15, 2013
• Last updated: May 9, 2014
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French ministry of health
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Haemorrhage
• Hemorrhage
• Subarachnoid Hemorrhage
• World Neurosurgeon Federation Score = III

Intervention

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

Locations

Country	Name	City	State
France	University Hospital	Nantes
France	University Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurologic outcome	modified Rankin Scale (mRS). Poor neurological outcome was considered as death or severe disability (mRS 5-6).	3 months	No
Secondary	Correlation between cardiac strain on day 1 and Left Ventricular Ejection fraction		Day 1	No
Secondary	Correlation between cardiac enzymes (NT-proBNP, troponin T US) and cardiac strain		Day 1	No
Secondary	Correlation between EKG findings and cardiac strain		Day 1	No
Secondary	Time to amines discontinuation		During Intensive Care Unit stay, expected average 17 days	No
Secondary	Duration of mechanical ventilation		Duration of mechanical ventilation, expected average 15 days	No
Secondary	Length of ICU stay		Duration of ICU stay, expected average 17 days	No
Secondary	Correlation between Cardiac function and Mechanical Ventilation		Day1, day3, day7 and extubation time expected average 15 days	No
Secondary	Correlation between Cardiac function and ICU length of stay		Day1, day3, day 7 and end of stay in ICU expected average 17 days	No