Treatment of severe acute respiratory failure patients requiring Extracorporeal Membrane Oxygenation (ECMO)

Treatment of severe acute respiratory failure patients requiring Extracorporeal Membrane Oxygenation (ECMO) Study protocol No.: MJ-CP042-01-01 - MJ-CP042-01-01

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1092220327

Enrollment

Registered

2018-02-01

Start date

2018-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

severe acute respiratory failure patients requiring treatment by the Extracorporeal Membrane Oxygenation (ECMO)

Interventions

Intervention type:DEVICE Name of intervention:MJ-CP042-01 Dose form / Japanese Medical Device Nomenclature:DEVICE Route of administration / Site of application:NOT APPLICABLE Dose per administration:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients who are able to provide written consent to participate in the study 2.Ages between 20 and 75 years old; no gender restriction 3.Longer than 6 hours of ECMO therapy is expected 4.Meets at least one of the 3 criteria below: -FiO2 >0.8, PFR=10cmH2O -Uncompensated hypercapnia (PaCO2 >80mmHg) in spite of PIP>=30cmH2O -Serious air leak syndrome

Exclusion criteria

Exclusion criteria: 1.Cause of the severe respiratory failure is determined to be irreversible respiratory disease 2.Remaining on high ventilator settings (FiO2 >0.9, PIP >30cmH2O) for more than 7 days 3.Serious immunodeficiency (Neu<400mm3) 4.Pre-existing conditions (central nervous system disorder, end-stage malignancy, systemic bleeding risk due to ECLS anticoagulation) which may have significant impact on QOL 5.Severe aortic valve insufficiency in the case of VA circulation 6.Patients with known hypersensitivity to heparin 7.Patients currently suffering from, or with a history of type II antibody-related, heparin-induced thrombocytopenia (HIT) 8.Pregnant or possibility of pregnancy 9.Participating in another clinical trial or Postmarketing clinical study 10.Those patients determined by the investigator to be inappropriate to participate in the trial

Design outcomes

Primary

Measure	Time frame
Duration of MJ-CP042-01 used	—

Secondary

Measure	Time frame
-Change in patient PFR -Changes in device PFR and pressure gradient pre/post oxygenator -Rate of device (procedure) change due to subject condition -Percentage of patients on ECMO after 6 hours -Percentage of patients on ECMO after 14 days -Other parameters at 14 and 30 days: -Overall survival rate and survival rate of patients who were weaned -Exchange of device due to device failure (frequency, days used) -Average time device is used when there is no device exchange (except for death) -Average time device is used in all patients without device exchange -Over all average of hours device is used	—

Measure

Time frame

-Change in patient PFR -Changes in device PFR and pressure gradient pre/post oxygenator -Rate of device (procedure) change due to subject condition -Percentage of patients on ECMO after 6 hours -Percentage of patients on ECMO after 14 days -Other parameters at 14 and 30 days: -Overall survival rate and survival rate of patients who were weaned -Exchange of device due to device failure (frequency, days used) -Average time device is used when there is no device exchange (except for death) -Average time device is used in all patients without device exchange -Over all average of hours device is used

—

Countries

Japan

Contacts

Public ContactMasaru Ohara

Getinge Group Japan K.K.

masaru.ohara@getinge.com+81-3-5463-8311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026