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

NCT02527031 | Completed DMC

• 2 other identifiers: HParis2012-A00829-34
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest; Sudden Death

Keywords

Emergency Medical Services; Extracorporeal Membrane Oxygenation

Outcome Measures

Primary Outcomes (1)

• Survival with good neurological outcome (CPC 1 or 2)

  At 6 months or participants will be followed for the duration of hospital stay, an expected average of 6 weeks

Secondary Outcomes (8)

• Success rate of the implementation of ECMO

  Immediate

• ECMO implementation time

  Immediate

• Immediate complications: haemorrhage, infection

  One day

• Number of organ harvesting

  6 months

• The quality of survivors' neurological status according to the CPC neurological classification at D 28

  28 days

Study Arms (2)

Pre hospital ECMO

ACTIVE COMPARATOR

ECMO Insertion on pre hospital setting for a refractory cardiac arrest

Other: ECMO Insertion on pre hospital setting

In Hospital ECMO

ACTIVE COMPARATOR

ECMO Insertion on in hospital setting for a refractory cardiac arrest

Other: In Hospital ECMO

Interventions

ECMO Insertion on pre hospital setting OTHER

ECMO Insertion on pre hospital setting

Pre hospital ECMO

In Hospital ECMO OTHER

ECMO Insertion on in hospital setting for a refractory cardiac arrest

In Hospital ECMO

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Absence of major co-morbidity. And Extra-corporeal Membrane Oxygenation (ECMO) team available and on-site before the 40th minute

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Maquet Cardiovascular: collaborator

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

MeSH Terms

Conditions

Heart Arrest; Death, Sudden

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lionel Lamhaut, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: August 18, 2015
• Study Start: March 29, 2016
• Primary Completion: August 26, 2019
• Study Completion: July 3, 2020
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

FR (1)