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Recruiting NCT06676085

A Novel Strategy of ECMO Management Using Nafamostat for Regional Combined With Low Intensity Systematic Anticoagulation

No phase Interventional ECMO

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nafamostat, Heparin.
Who it may be relevant to
Registry conditions: ECMO. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Novel Strategy Combined Regional Anticoagulation in Membrane Oxygenator and Low-intensity of Systemic Anticoagulation Applied in Management of Extracorporeal Membrane Oxygenation

Overview

ECMO is widely used in patients with refractory respiratory and/or circulatory failure.The data shows that the incidence of bleeding and thrombotic events is still above 40%,and it is closely related to the increase in mortality rate.Therefore, optimizing ECMO anticoagulation management to reduce bleeding and thrombotic events is a key scientific issue that urgently needs to be addressed.

Interventions

  • Drug Nafamostat
    Nafamostat combined with unfractionated heparin for anticoagulation
  • Drug Heparin
    unfractionated heparin for anticoagulation

Primary outcome measures

  • incidence of ECMO related bleeding or thrombotic events [Time frame: 28 days]

Eligibility criteria

Inclusion criteria

  • age older than 18 years old
  • received ECMO because of severe respiratory failure

Exclusion criteria

  • anticoagulant contraindications
  • cerebral infarction or suspected patients
  • severe hypertension
  • women in gestational and lactational period
  • hemophilia
  • allergic to heparin or Nafamostat
  • unwilling or unable to complete the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Bing Sun — Beijing

Identifiers

NCT: NCT06676085 · Nafamostat in ECMO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗