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Emergency Cardiopulmonary Bypass for Cardiac Arrest

NCT01605409 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-03-26

No results posted yet for this study

Summary

Cardiac arrest ist associated with a very poor prognosis. Even though resuscitation algorithms and postcardiac arrest care have been improved there is an urgent need for measures leading to a higher survival rate.

Emergency cardiopulmonary bypass (ECPB - artificial heart and lung outside the patients body) is a method which has shown good results in case reports and animal studies for cardiac arrest care.

The study will be performed as comparison between the new treatment option of ECPB versus the standard of care treatment.

Aim of our study is to determine the feasibility of ECPB installed in an emergency department to improve the rate of patients restoration of spontaneous circulation.

Conditions

  • Cardiac Arrest

Interventions

PROCEDURE

Emergency cardiopulmonary bypass under ongoing CPR

Emergency cardiopulmonary bypass under ongoing CPR Emergency cardiopulmonary bypass (ECMO: lifebridge (Sorin®) or cardiohelp(Maquet®) will be initiated percutaneously ultrasound guided, during CPR efforts at the Emergency department. Cannulae and tubing in use will be heparin coated. ECMO flow will be set to 70ml/kgBW/min. Anticoagulation will achieved with unfractionated heparin and monitored using ACT.

PROCEDURE

Standard ACLS

Standard ACLS Standard ACLS provided by EMS personnel according to current guidelines of the European resuscitation council. Transportation: Transport will be initiated as soon as the patient achieves ROSC in the field and transportation is feasible. All patients will be admitted to the ED at the Vienna general hospital. Standard Post resuscitation Management: After admission to the ED post resuscitation care and standardized intensive care treatment will be provided according to Utstein protocol and current standards for good clinical practice and according to ILCOR recommendations. A crossover to the ECPB group is possible, if indicated by good clinical practice. If so, it will be counted as treatment failure in the standard ACLS group. If no ROSC can be achieved and the patient dies in the field pathological results will be obtained if feasible.

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Andreas Schober, MD · Medical University Vienna, Austria, Dept. of Emergency Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2020-12-31
Completion
2021-05-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01605409 on ClinicalTrials.gov