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Aneurysmal Subarachnoid HaemorrhageSPLASHNCT01801800

Cardiac Function in Severe Aneurysmal Subarachnoid Haemorrhage Patients

An observational study of Aneurysmal Subarachnoid Haemorrhage and World Neurosurgeon Federation Score ≥ III, run by Nantes University Hospital at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 15 to 85 years
What is being tested?
Echocardiography
Type of treatment
Surgery or procedure
How many people
80 participants
Where
2 sitesFrance
Study dates
Jan 2012to Dec 2013
How long will I take part?
2 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 85 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Severe Aneurysmal subarachnoid haemorrhage

Who may be able to join

  • Aneurysmal subarachnoid haemorrhage
  • World Neurosurgeon Federation Score ≥ III
  • Written information to next-of-kin and patients when possible

Who cannot join

  • History of myocardial infarction, chronic heart failure with NYHA ≥ 2, major heart surgery
  • Lack of acoustic window to perform trans-thoracic echocardiography

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • University Hospital

    Nantes, 44000

  • University Hospital

    Rennes, 35000

Other trials in France

About this study

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

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

Read the 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

Being tested
Echocardiography
Keywords
Aneurysmal subarachnoid haemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EchocardiographyProcedure or surgery

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

Study groups in NCT01801800
Study groupRoleWhat they receive
Aneurysmal subarachnoid haemorrhageSpeckle-tracking images in Echocardiography
Receives: Procedure: Echocardiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neurologic outcome

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

    Measured: 3 months

Secondary outcomes (8)

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

    Measured: Day 1

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

    Measured: Day 1

  3. Correlation between EKG findings and cardiac strain

    Measured: Day 1

  4. Time to amines discontinuation

    Measured: During Intensive Care Unit stay, expected average 17 days

  5. Duration of mechanical ventilation

    Measured: Duration of mechanical ventilation, expected average 15 days

  6. Length of ICU stay

    Measured: Duration of ICU stay, expected average 17 days

  7. Correlation between Cardiac function and Mechanical Ventilation

    Measured: Day1, day3, day7 and extubation time expected average 15 days

  8. Correlation between Cardiac function and ICU length of stay

    Measured: Day1, day3, day 7 and end of stay in ICU expected average 17 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2013 (estimated)
  2. Study startJan 2012
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
80 participants (estimated)
Target duration
2 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT01801800
Sponsor's protocol ID
RC12_0410
Acronym
SPLASH
Status last verified
May 2014
First submitted
15 Feb 2013
Last updated
12 May 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19269254

Questions about this trial

What is this clinical trial studying?

An observational study of Aneurysmal Subarachnoid Haemorrhage and World Neurosurgeon Federation Score ≥ III, run by Nantes University Hospital at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurologic outcome (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01801800, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2014.

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