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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN67856342 |
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Date of registration:
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20/07/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The use of erythropoietin in cardiac arrest victims: the impact on survival and neurological outcome
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Scientific title:
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Date of first enrolment:
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01/06/2007 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN67856342 |
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Study type:
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Interventional |
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Study design:
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Prospective, multi-centre (three emergency medical service centres) randomised controlled trial. (Treatment)
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Phase:
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Countries of recruitment
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Slovenia
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Contacts
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Name:
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?tefek
Grmec |
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Address:
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Ulica talcev 9
2000
Maribor
Slovenia |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. 18 years or older
2. Non-traumatic, cardiac arrest in pre-hospital setting when started with cardiopulmonary reanimation irrespective of initial cardiac rhythm
Exclusion criteria: 1. Traumatic cardiac arrest
2. Under 18 years of age
3. Cardiopulmonary Resuscitation (CPR) without drugs (only defibrillation)
4. Pregnancy
5. Severe hypothermia (<30°C)
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cardiac arrest
Circulatory System
Cardiac arrest
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Intervention(s)
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The patients in the intervention group will receive a bolus of EPO (90000 IU) in first four minutes during the CPR process. Intraosseous route is an alternative. Early application of the drug is crucial to cover the period of ischaemia and reperfusion which are both connected with brain in myocardial injury and possibility of malignant heart arrhythmias. In the case of ROSC all the patinets will be cooled down by the process of induced therapeutic hypothermia receiving sterile physiological saline with the temperature of 4°C and the speed 100 ml/hour.
Both intervention and control groups (group with and without erythropoietin) will be treated according the latest guidelines for cardiopulmonary resuscitation (the International Liaison Committee on Resuscitation [ILCOR] - European Resuscitation Council).
All the data will be collected under the ILCOR recommendation in Utstein style and checked by two independent researchers. Neurological function of the patients will be assessed and categorized with Cerebral Performance Score (CPS).
The following data will also be collected:
1. Capnometry
2. Initial heart rhythm
3. Age
4. Gender
5. Withness of cardiac arrest
6. Lay bystanders CPR
7. Response time
8. Respiratory Rate (RR)
9. Echocardiography
10. Protein S 100
11. Creatinine Kinase (CK)
12. Sodium (Na)
13. Chloride (Cl)
14. Pottasium (K)
15. Calcium (Ca)
16. Magnesium (Mg)
17. Lactate
18. Brain Computed Tomography (CT)
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Primary Outcome(s)
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Neurological outcome assessed by CPC, from CPC-1 (normal neorological status) to CPC-5 (brain death). This will be measured six months after cardiopulmonary resuscitation.
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Secondary Outcome(s)
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1. ROSC in the field (%)
2. ROSC with admission to hospital
3. 24-hour survival
4. Survival (discharge from hospital)
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Secondary ID(s)
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CNMPEPO 001
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Source(s) of Monetary Support
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Centre for Health and Emergency Medicine (Zdravstveni dom adolfa drolca maribor) (Slovenia)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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