Welcome
Support Centre
27 August 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Activity and Life After Survival of a Cardiac Arrest
ISRCTN ISRCTN74835019
DOI 10.1186/ISRCTN74835019
ClinicalTrials.gov identifier
EudraCT number
Public title Activity and Life After Survival of a Cardiac Arrest
Scientific title
Acronym ALASCA
Serial number at source date 08-02-2007/ version 2
Study hypothesis 1.1. The level of cognitive, emotional and cardiorespiratory impairment, daily functioning, participation in society and quality of life are expected to be lower than in the general population. Daily functioning and participation in society are lower than before the cardiac arrest. Caregiver strain is expected to be higher than in the general population
1.2. Cognitive functioning is significantly related to participation in society and quality of life. Participation is significantly related to quality of life. Caregiver strain is higher when the levels of functioning of the cardiac arrest survivor are lower
2. Expected prognostic factors for cognitive impairment, daily functioning, participation in society and quality of life one year after a cardiac arrest are: age, educational level, early Cardiopulmonary resuscitation (CPR), initial cardiac rhythm, duration of the hypoxic period (interval collapse-to-return of spontaneous circulation), Glasgow Coma Score at admission, application of mild therapeutic hypothermia, duration post-traumatic amnesia, Implantable Cardioverter Defibrillator (ICD) placement, cognitive functioning (measured with O-log) at two weeks, cardiorespiratory functioning, presence of a caregiver
3.1. The routine early intervention service after survival of a cardiac arrest is more effective than usual care with regard to the level of participation in society and quality of life
3.2. The routine early intervention service is cost-effective compared to usual care
3.3. The routine early intervention service has an acceptable cost-utility (cost per Quality Adjusted Life Year [QALY])
Lay summary
Ethics approval Approved by the Medical Ethics Commitee of Maastricht University/Maastricht Academic Hospital on the 14th March 2007.
Study design Prospective cohort study with a nested, randomised, controlled clinical trial.
Countries of recruitment Netherlands
Disease/condition/study domain Survivors of a cardiac arrest, hypoxic brain injury
Participants - inclusion criteria All survivors of a cardiac arrest (survival greater than two weeks) admitted at or to one of the participating hospitals between April 2007 and April 2011.
Participants - exclusion criteria 1. Severe non-cardiac co-morbidity with a life expectancy lower than three months
2. Participant was living in an institutional care facility prior to the cardiac arrest
Anticipated start date 01/04/2007
Anticipated end date 01/04/2011
Status of trial Completed
Patient information material
Target number of participants 240
Interventions The intervention group receives a routine early intervention service consisting of several contacts with a specialised nurse. The intervention is directed at early detection of (cognitive) problems, information supply and provision of support to the patient and their caregiver. If indicated, the patient can be referred to specialised care. The intervention will take place during the first three months after the cardiac arrest. Participants will have three to six consultations with the specialised nurse.

The control group receives care as usual.
Primary outcome measure(s) 1. Participation in society
2. Quality of life

All outcome measures will be admistered two weeks, three months and one year after the cardiac arrest.
Secondary outcome measure(s) 1. Cognitive, emotional and cardiorespiratory impairment
2. Daily functioning
3. Caregiver strain

All outcome measures will be admistered two weeks, three months and one year after the cardiac arrest.
Sources of funding 1. The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
2. The Nuts-Ohra Foundation (Stichting Nuts Ohra [SNO]) (The Netherlands)
Trial website
Publications Study protocol: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17723148
Contact name Ms  Véronique  Moulaert
  Address Research Department
Rehabilitation Foundation Limburg
P.O. Box 88
  City/town Hoensbroek
  Zip/Postcode 6430 AB
  Country Netherlands
  Email v.moulaert@srl.nl
Sponsor The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
  Address P.O. Box 93245
  City/town Den Haag
  Zip/Postcode 2509 AE
  Country Netherlands
  Sponsor website: http://www.zonmw.nl
Date applied 04/04/2007
Last edited 10/09/2007
Date ISRCTN assigned 01/06/2007
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.