|- candidate number||15275|
|- NTR Number||NTR4118|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-aug-2013|
|- Secondary IDs||NL45096.008.13 METC nr. 1347|
|- Public Title||Study with Copeptin as predictor of outcome in patients with a subarachnoid haemorrhage from a ruptured cerebral aneurysm.|
|- Scientific Title||Tilburg Copeptin in aSAH patients Study
|- hypothesis||Could copeptin be used as a marker for prognosis and severity of aSAH in Dutch intensive care populations?|
|- Healt Condition(s) or Problem(s) studied||Subarachnoid hemorrhage (SAH), Cerebral aneurysm|
|- Inclusion criteria||Admission to the intensive care of the St. Elisabeth Hospital Tilburg.|
Age 18 year or over.
Start clinical symptoms of SAH within 24hr at admission.
Informed consent to participate in the trial.
Aneurysm confirmed by computerized tomography angiography (CT-A) with or without digital substraction angiography (DSA).
Blood drawn after obtaining informed consent on the first 24 hours of admission at de ICU.
|- Exclusion criteria||Less than 18 years of age.|
Severe language barrier, unable to read the informed consent.
SAH due to non- aneurysmal causes.
Recent ischemic or hemorrhagic stroke (< 30 days).
Recent intracerebral hemorrhage without subarachnoid blood (< 30 days).
Existing recent head trauma (< 30 days).
Recent acute myocardial infarction (AMI)(< 30 days).
Chronic heart failure.
Recent acute exacerbation of COPD (AECOPD) (< 30 days).
Recent sepsis/septic shock (< 30 days).
Recent acute pancreatiits (< 30 days).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-okt-2013|
|- planned closingdate||1-okt-2014|
|- Target number of participants||103|
|- Interventions||For copeptin levels in the aSAH group, blood will be drawn in an extra serum tube of 5 ml on the first 24 hours of admission at the ICU.|
|- Primary outcome||The primary objective is to investigate the ability of copeptin to predict poor one-year functional outcome, GOS 1-3, in patients with aneurysmal SAH in the Dutch population.|
|- Secondary outcome||•Development of DCI|
•Case fatality 30 days after admission
•One year mortality
•Functional outcome 12 months after aSAH, assessed by both the Glasgow Outcome Scale and the modified Ranking Scale.
|- Timepoints||30 days and 12 months after the aSAH, the general practitioner of the patient will be contacted to check whether the patient is still alive. After 12 months alive patients will be contacted by the research nurse for a questionnaire by telephone. |
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||drs. J.A.H. Oers, van|
|- CONTACT for SCIENTIFIC QUERIES||drs. J.A.H. Oers, van|
|- Sponsor/Initiator ||St. Elisabeth Hospital, Tilburg|
(Source(s) of Monetary or Material Support)
|- Brief summary||SUMMARY
Subarachnoid haemorrhage from a ruptured cerebral aneurysm (aSAH) is a significant cause of mortality and morbidity throughout the world. Multiple clinically grading scales are developed to indicate the severity of neurological injury, and to provide prognostic information regarding outcome. However, prediction of outcome remains difficult and complicates decision making for active treatment. Copeptin, the C-terminal part of the arginine vasopressin precursor peptide, is associated with the severity and outcome of critical illness. Recently it has been reported that initial high levels of copeptin in blood are highly predictive for poor outcome and vasospasm in patients presenting with aSAH in the Chinese population.
The aim of this prospective study is to elucidate whether copeptin could be used as a marker for prognosis and severity of aSAH in Dutch intensive care populations?
A single center prospective observational study
Patients admitted to the ICU of the St. Elisabeth Hospital with an age of 18 years or over with clinical symptoms of SAH within 24 hours at admission in which a cerebral aneurysm is confirmed by computerized tomography angiography (CT-A) with or without digital substraction angiography (DSA).
After informed consent is obtained blood will be drawn in an serum tube of 5 ml on the first 24 hours of admission at de ICU for copeptin levels in the aSAH group. Included aSAH patients will be evaluated for delayed cerebral ischaemia (DCI). 30 days and 12 months after the aSAH, alive patients will be contacted by the research nurse for a questionnaire by telephone, including the Glasgow Outcome Scale (GOS) and the modified Ranking Scale (mRS). In a control group of 30 healthy volunteers without cardiovascular risk factors and without any neurological deficits of copeptin levels will be estimated to compare these results with the copeptin levels of the included aSAH patients.
Main outcome measurement
Poor one-year functional outcome, GOS 1-3, development of DCI, case fatality 30 days after admission, one year mortality and functional outcome 12 months after aSAH, assessed by both Glasgow Outcome Scale and the modified Ranking Scale.
|- Main changes (audit trail)|
|- RECORD||15-aug-2013 - 12-feb-2017|