A Comparative Study Between a Pre-hospital and an In-hospital Circulatory Support Strategy (ECMO) in Refractory Cardiac Arrest (APACAR2) (APACAR2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02527031|
Recruitment Status : Recruiting
First Posted : August 18, 2015
Last Update Posted : April 17, 2018
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.
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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 ]
- Success rate of the implementation of ECMO [ Time Frame: Immediate ]Flow rate more than 2,5 Liters / minutes
- ECMO implementation time [ Time Frame: Immediate ]Time between incision and pomp started
- Immediate complications: haemorrhage, infection [ Time Frame: One day ]
- Number of organ harvesting [ Time Frame: 6 months ]
- The quality of survivors' neurological status according to the CPC neurological classification at D 28 [ Time Frame: 28 days ]
- The quality of survivors' neurological status according to the CPC neurological classification at 2 months [ Time Frame: 2 months ]
- The quality of survivors' neurological status according to the CPC neurological classification at 1 year [ Time Frame: 1 year ]
- 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 ]
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
|Contact: Lionel Lamhaut, MD||+33 1 44 49 54 firstname.lastname@example.org|
|Contact: Nelly Briand, PhD||+33 1 44 38 18 email@example.com|
|Hôpital Necker-Enfants Malades||Recruiting|
|Paris, France, 75015|
|Contact: Lionel Lamhaut, MD, PhD +33 1 44 49 54 07 firstname.lastname@example.org|
|Principal Investigator:||Lionel Lamhaut, MD||Assistance Publique - Hôpitaux de Paris|