- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02934867
Out of Hospital Cardiac Arrest: Trial Assessing the Survival Impact of Phone Advice (CONTAC)
January 24, 2020 updated by: Centre Hospitalier Universitaire de Besancon
Out of Hospital Cardiac Arrest: Cluster Randomized Trial Assessing the Survival Impact of Phone Advice Delivered by Medical Call Center
Medical call center have no phone advice protocol within out of hospital cardiac arrest in France.
The purpose of the present study is to compare a group of patients with protocol phone advice delivered by the dispatchers ("CONTARM" group) versus usual phone advice ( "CONTHAB" group).
Comparison will be performed on survival to seven days.
The hypothesis is that CONTARM group has an higher survival at seven days.
A second goal is to measure the survival to 15 and 30 days.
The trial is randomized, controlled and will include 2600 patients.
The patients will be enrolled in 19 hospitals in France.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
2600
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Angers, France
- Recruiting
- Chu Angers
-
Contact:
- David Hamdan, MD
- Phone Number: 02 41 35 32 97
- Email: hamdandavid@yahoo.fr
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Besançon, France
- Recruiting
- CHU Besançon
-
Contact:
- Jean-Marc Labourey, MD
- Phone Number: 03 81 66 82 59
- Email: jmlabourey@chu-besancon.fr
-
Bordeaux, France
- Recruiting
- CHU Bordeaux
-
Contact:
- Catherine Pradeau, MD
- Email: catherine.pradeau@chu-bordeaux.fr
-
Châlon sur Saône, France
- Recruiting
- CH Chalon sur Saône
-
Contact:
- David Corrège, MD
- Phone Number: 03 85 91 00 76
- Email: david.corege@ch-chalon71.fr
-
Colmar, France
- Recruiting
- CH Colmar
-
Contact:
- Yannick Gottwallès, MD
- Phone Number: 03 89 12 40 96
- Email: yannick.gottwalles@ch-colmar.fr
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Dijon, France
- Recruiting
- CHU Dijon
-
Contact:
- Cindy Tissier, MD
- Phone Number: 03 80 29 51 12
- Email: cindy.tissier@chu-dijon.fr
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Lons Le Saunier, France
- Recruiting
- CH Lons Le Saunier
-
Contact:
- Yves Duffait, MD
- Phone Number: 03 84 35 60 03
- Email: yvesgaelle@hotmail.com
-
Lyon, France
- Recruiting
- CHU LYON
-
Contact:
- Pierre Yves Gueugniaud, MD
- Phone Number: 04 72 11 00 41
- Email: pierre-yves.gueugniaud@chu-lyon.fr
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Metz, France
- Recruiting
- CHU Metz
-
Contact:
- François Braun, MD
- Phone Number: 03 87 55 92 92
- Email: fr.braun@chr-metz-thionville.fr
-
Montauban, France
- Recruiting
- CH Montauban
-
Contact:
- Adeline Sourbes, MD
- Phone Number: 05 63 92 81 51
- Email: a.sourbes@ch-montauban.fr
-
Mulhouse, France
- Recruiting
- CH Mulhouse
-
Contact:
- Frédéric Pernot, MD
- Phone Number: 03 89 64 62 72
- Email: pernotf@ch-mulhouse.fr
-
Nancy, France
- Recruiting
- Chu Nancy
-
Contact:
- Lionel Nace, MD
- Phone Number: 03 83 85 14 96
- Email: l.nace@chru-nancy.fr
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Nantes, France
- Recruiting
- CHU Nantes
-
Contact:
- Joel Jenvrin, MD
- Phone Number: 05 56 79 56 79
- Email: catherine.pradeau@chu-bordeaux.fr
-
Nîmes, France
- Recruiting
- Chu Nimes
-
Contact:
- Olivier Onde, MD
- Phone Number: 04 66 68 37 08
- Email: olivier.onde@chu-nimes.fr
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Orléans, France
- Recruiting
- CH Orleans
-
Contact:
- Sophie Narcisse, MD
- Phone Number: 02 38 22 98 54
- Email: sophie.narcisse@chr-orleans.fr
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Poitiers, France
- Recruiting
- CHU Poitiers
-
Contact:
- Nicolas Marjanovic, MD
- Phone Number: 05 49 44 44 88
- Email: nicolasmarjanivic@free.fr
-
Reims, France
- Recruiting
- CHU Reims
-
Contact:
- Alain Léon, MD, PhD
- Phone Number: 03 26 78 70 30
- Email: aleon@chu-reims.fr
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Strasbourg, France
- Recruiting
- CHU Strasbourg
-
Contact:
- Hervé Delplancq, MD
- Phone Number: 03 69 55 31 42
- Email: herve.delplancq@chru-strasbourg.fr
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Troyes, France
- Recruiting
- CH Troyes
-
Contact:
- Arnaud Malbranque, MD
- Phone Number: 03.25.49.49.49
- Email: arnaud.malbranque@ch-troyes.fr
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- > 18 years old
- initial call to 15
- out of hospital cardiac arrest
- patient proximity to witness
Exclusion Criteria:
- first aid professionals on site
- rigor mortis
- location not allowing resuscitation
- inability to realize actions or misunderstanding
- no flow > 5 minutes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CONTARM
Protocol phone advice
|
Protocol phone advice
|
Other: CONTHAB
Usual phone advice
|
Usual phone advice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
7 days survival
Time Frame: 7 days
|
7 days survival
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
15 and 30 days survival
Time Frame: 15 and 30 days
|
15 and 30 days survival
|
15 and 30 days
|
Assessment of compliance of phone advice
Time Frame: 7 days
|
Listening of phone bands to measure compliance of phone advice protocol :
|
7 days
|
30 days neurological status
Time Frame: 30 days
|
Cerebral performance categories scale is counting with medical file
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Nolan JP, Soar J, Zideman DA, Biarent D, Bossaert LL, Deakin C, Koster RW, Wyllie J, Bottiger B; ERC Guidelines Writing Group. European Resuscitation Council Guidelines for Resuscitation 2010 Section 1. Executive summary. Resuscitation. 2010 Oct;81(10):1219-76. doi: 10.1016/j.resuscitation.2010.08.021. No abstract available.
- Berg RA, Hemphill R, Abella BS, Aufderheide TP, Cave DM, Hazinski MF, Lerner EB, Rea TD, Sayre MR, Swor RA. Part 5: adult basic life support: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010 Nov 2;122(18 Suppl 3):S685-705. doi: 10.1161/CIRCULATIONAHA.110.970939. Erratum In: Circulation. 2011 Oct 11;124(15):e402.
- Koster RW, Baubin MA, Bossaert LL, Caballero A, Cassan P, Castren M, Granja C, Handley AJ, Monsieurs KG, Perkins GD, Raffay V, Sandroni C. European Resuscitation Council Guidelines for Resuscitation 2010 Section 2. Adult basic life support and use of automated external defibrillators. Resuscitation. 2010 Oct;81(10):1277-92. doi: 10.1016/j.resuscitation.2010.08.009. No abstract available.
- Desmettre T, Jenvrin J, Freysz M, Nace L, Puyraveau M, Berthier F, Dreyfus P, Philippe MH, Labourey JM, Capellier G. Drug prescription at the medical call center. Ann. Fr. Med. Urgence (2013) 3:14-19.
- Sigaux A, Jonquet S, Puyraveau M, Bretillot L, Labourey JM, Capellier G, Desmettre T. Evaluation of phone advice delivered by a medical call center in case of cardiac arrest. Ann. Fr. Med. Urgence (2014) 4:11-17.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Anticipated)
November 1, 2020
Study Completion (Anticipated)
April 1, 2021
Study Registration Dates
First Submitted
July 26, 2016
First Submitted That Met QC Criteria
October 13, 2016
First Posted (Estimate)
October 17, 2016
Study Record Updates
Last Update Posted (Actual)
January 27, 2020
Last Update Submitted That Met QC Criteria
January 24, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CONTAC R/2015/50
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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