Clinical trial NCT04183660: A Post Market Surveillance Study of the Hemovent Extracorporeal Cardiopulmonary Support System:The MOBYBOX Trial
Official title: A Post Market Surveillance Study of the Hemovent Extracorporeal Cardiopulmonary Support System for Cardiac and Respiratory Support: The MOBYBOX Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Failure
Respiratory Failure
Cardio-Respiratory Failure
Imminent Cardiorespiratory or Respiratory Failure
Lead sponsor: Hemovent GmbH
Sponsor class: INDUSTRY
Collaborators: name: seleon GmbH
First posted: 2019-12-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consented patients with cardiorespiratory failure or ith severe respiratory failure who meet all of the inclusion and none of the exclusion criteria and in whom the investigator intends to treat the patient with cardiopulmonary support using the Hemovent MOBYBOX System.

Brief summary: The purpose of this study is to evaluate prospectively the safety and performance of the MOBYBOX System in the veno-arterial configuration in patients with cardiorespiratory failure or in the veno-venous configuration in patients with severe respiratory failure.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with cardiac, respiratory or cardiorespiratory failure or imminent failure and 1 of the 5 following sets of findings:

  1. A Murray score ≥ 3.0 and/or severe hypoxemia with A PaO2/FIO2 \> 100 mm on 0.9 FIO2;
  2. Uncompensated hypercapnia with pH \<7.2 despite a Pplateau \> 30 cm H20;
  3. Significant air leak/bronchopleural fistula;
  4. Need for intubation in a patient on lung transplant list;
  5. Immediate/risk of cardiac or respiratory collapse (pulmonary embolus, blocked airway, blocked blood flow, unresponsive to optimal care);
* Written consent of the patient or the legal guardian or external consulting physician as designated and approved by the Ethics Committee.

Exclusion Criteria:

* High pressure ventilation (FIO2 \> 0.9 and Pplateau \> 30 cm H2O) or high FIO2 requirements for more than 7 days;
* Severe intracranial bleeding, which precludes the use of anticoagulation therapy or any other inability to be anticoagulated
* Excessive weight (\> 180 Kg)
* Severe irreversible brain injury (e.g., hypoxic brain injury)
* Inability to accept blood products;
* Any condition or organ dysfunction that would limit the likelihood of overall benefit from ECMO, such as severe, irreversible brain injury, hepatic and/or renal failure, or untreatable metastatic cancer;
* Immunosuppression with an absolute neutrophil count \< 400/mm3;
* Patient has been treated with ECMO ≤ 48 hours.
* For veno-veno ECMO in the setting of respiratory failure the following exclusion criteria apply:
* Severe pulmonary hypertension (mPAP \> 50 mm Hg)
* Severe right or left sided heart failure (EF \< 25%)
* For veno-arterial ECMO in the setting of cardiac insufficiency:
* Severe aortic regurgitation
* Aortic dissection.
* The patient is moribund, or the patient has severe or deteriorating damage in critical body systems.
* Patient is participating in an investigational drug or device study trial that has not reached the primary endpoint or that interferes with the current study endpoints.
* Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.

Primary outcomes:
measure: Rates of device and procedure related serious adverse events
timeFrame: 24 hours
Secondary outcomes:
measure: Device performance success
timeFrame: every 4 hours while the patient receives ECMO using the MOBYBOX device
measure: Adverse Event rate
timeFrame: 24 hours
measure: Mortality rate
timeFrame: 30 days
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
state: NRW
city: Halle
country: Germany
facility: Universitätsklinikum Halle
state: Sachsen-Anhalt
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt
Study officials:
affiliation: Uniklinikum Essen
name: Tienush Rassaf, Prof.
role: PRINCIPAL_INVESTIGATOR
References: