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Trial record 2 of 2045 for:    Recruiting, Not yet recruiting, Available Studies | "Hospitals"

A Comparative Study Between a Pre-hospital and an In-hospital Circulatory Support Strategy (ECMO) in Refractory Cardiac Arrest (APACAR2) (APACAR2)

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ClinicalTrials.gov Identifier: NCT02527031
Recruitment Status : Recruiting
First Posted : August 18, 2015
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
Maquet Cardiovascular
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

Cardiac arrest (CA) affects approximately 40,000 people in France. It is still a major cause of death in a young population. Management of CA is defined by international recommendations, detailed by learned societies in each country. It includes several links that are interconnected for its optimisation. Despite all these improvements, no progress, or little has been made in the survival of CA victims over the past few years in industrialised countries, and the survival rate in France is 3% to 5%.

Refractory cardiac arrest is defined as failure, after 30 minutes of specialised resuscitation. It used to be the standard to admit that there was no hope of spontaneous cardiac activity and satisfactory neurological recovery after this period, except in cases of CA with neuroprotection (intoxication, hypothermia).

External circulatory support such as "extracorporeal membrane oxygenation" (ECMO) makes it possible to replace the circulatory activity of the myocardium and the respiratory activity of the lungs.

In in-hospital cardiac arrest (CA) some teams use ECMO with an improvement in the survival rate of 20% in comparison to standard resuscitation. This use demonstrates the possibility of neurological recovery independent of the recovery of spontaneous cardiac activity which can be differed.

These results encouraged the use of ECMOs in cases of out-of-hospital refractory cardiac arrests. Patients who are victims of CA are resuscitated for 30 minutes on the spot where the CA occurs. They are then transferred to a specialised centre. The significant improvement in survival noted in in-hospital CAs was not observed in the French series of studies concerning out-of-hospital CAs. This survival is currently estimated at 4%. This difference can be partly explained by the difference in time between the beginning of cardiac massage and the implementation of circulatory support by ECMO ("low flow" period). This time period is directly correlated to survival.

To demonstrate the superiority of this strategy in terms of survival, investigators would like to conduct a randomised comparative study of two strategies: 1) installation of an ECMO between the 20th minute to the 30 minute of CA, directly at the site of the CA, by emergency physicians and/or specifically trained resuscitators 2) On-site resuscitation optimised with secondary transfer to the hospital for the implementation of support. The purpose is to increase by 5% to 20% the survival of victims of out-of-hospital refractory cardiac arrests with a good neurological prognosis.

Main objective:

The hypothesis is that pre-hospital ECMO will result in survival for 20% of the patients, considering that the percentage of survival with in-hospital ECMO is less than 5%.

Main judgement criterion:

Survival with good neurological outcome (CPC 1 or 2) on discharge from intensive care or at 6 months

Secondary judgement criteria:

Success rate of the implementation of ECMO ECMO implementation time Immediate complications: haemorrhage, infection Number of organ harvesting The quality of survivors' neurological status according to the CPC neurological classification at D 28, 2 months and 1 year Predictive indicators of the prognosis during cardiac arrest via cerebral and biological monitoring Methodology, type of study: This is a prospective randomised study of current care Sample size (SS, power, risk): A total number of 105 patients in each group will make it possible to demonstrate at the alpha risk of 5% and a power of 1-β=90%, a significant difference in favour of early pre-hospital ECMO compared to the current practice with in-hospital ECMO.


Condition or disease Intervention/treatment Phase
Cardiac Arrest Sudden Death Other: ECMO Insertion on pre hospital setting Other: In Hospital ECMO Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative Study Between a Pre-hospital and an In-hospital Circulatory Support Strategy (ECMO) in Refractory Cardiac Arrest
Actual Study Start Date : March 29, 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pre hospital ECMO
ECMO Insertion on pre hospital setting for a refractory cardiac arrest
Other: ECMO Insertion on pre hospital setting
ECMO Insertion on pre hospital setting

Active Comparator: In Hospital ECMO
ECMO Insertion on in hospital setting for a refractory cardiac arrest
Other: In Hospital ECMO
ECMO Insertion on in hospital setting for a refractory cardiac arrest




Primary Outcome Measures :
  1. Survival with good neurological outcome (CPC 1 or 2) [ Time Frame: At 6 months or participants will be followed for the duration of hospital stay, an expected average of 6 weeks ]

Secondary Outcome Measures :
  1. Success rate of the implementation of ECMO [ Time Frame: Immediate ]
    Flow rate more than 2,5 Liters / minutes

  2. ECMO implementation time [ Time Frame: Immediate ]
    Time between incision and pomp started

  3. Immediate complications: haemorrhage, infection [ Time Frame: One day ]
  4. Number of organ harvesting [ Time Frame: 6 months ]
  5. The quality of survivors' neurological status according to the CPC neurological classification at D 28 [ Time Frame: 28 days ]
  6. The quality of survivors' neurological status according to the CPC neurological classification at 2 months [ Time Frame: 2 months ]
  7. The quality of survivors' neurological status according to the CPC neurological classification at 1 year [ Time Frame: 1 year ]
  8. Predictive indicators of the prognosis during cardiac arrest via cerebral and biological monitoring (pupils reflex, breathing, gasp, movement, Cerebral saturation, pupils diameters,and lactates) [ Time Frame: 6 Months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible patients have the following combination of criteria:
  • Adults over 18 years of age and under 65 years of age
  • And Refractory cardiac arrest (defined by the failure of professionals to resuscitate at the 20th minute of cardiac arrest with a minimum of 3 Automatic External Defibrillator (AED) or equivalent analyze
  • And Beginning of external cardiac massage within the first 5 minutes after cardiac arrest (no flow < 5 min.) with shockable rhythm or the presence of signs of life during resuscitation (any rhythm): spontaneous movement, absence of mydriasis and/or pupillary response, spontaneous breathing movements
  • And Medical cause of the cardiac arrest
  • And End-Tidal CO2 (ETCO2) above 10 mm Hg at the time of inclusion
  • And Absence of major co-morbidity. And Extra-corporeal Membrane Oxygenation (ECMO) team available and on-site before the 40th minute

Exclusion Criteria:

  • Children under 18 years of age

    • Adults over 65 years of age
    • Period of more than 5 minutes without cardiac massage after collapsing
    • Known co-morbidity that compromises the prognosis for short or medium-term survival
    • Cardiac arrest during transportation times

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02527031


Contacts
Contact: Lionel Lamhaut, MD +33 1 44 49 54 07 lionel.lamhaut@aphp.fr
Contact: Nelly Briand, PhD +33 1 44 38 18 62 nelly.briand@aphp.fr

Locations
France
Hôpital Necker-Enfants Malades Recruiting
Paris, France, 75015
Contact: Lionel Lamhaut, MD, PhD    +33 1 44 49 54 07    lionel.lamhaut@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Maquet Cardiovascular
Investigators
Principal Investigator: Lionel Lamhaut, MD Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02527031     History of Changes
Other Study ID Numbers: HParis
2012-A00829-34 ( Other Identifier: ID-RCB )
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Emergency Medical Services
Extracorporeal Membrane Oxygenation

Additional relevant MeSH terms:
Heart Arrest
Death, Sudden
Heart Diseases
Cardiovascular Diseases
Death
Pathologic Processes