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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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ECMO

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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New Anticoagulation Strategy Group

Combination of nafamostat and unfractionated heparin for anticoagulation, adjusting the dosage of unfractionated heparin to maintain APTT in the body for 40-45 seconds, and adjusting the dosage of nafamostat to maintain APTT in the membranous lung for 50-60 seconds during ECMO

Group Type EXPERIMENTAL

Nafamostat

Intervention Type DRUG

Nafamostat combined with unfractionated heparin for anticoagulation

control group

Anticoagulation with unfractionated heparin, regulating the dosage of unfractionated heparin to maintain APTT in the body for 50-60s during ECMO.

Group Type ACTIVE_COMPARATOR

Heparin

Intervention Type DRUG

unfractionated heparin for anticoagulation

Interventions

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Nafamostat

Nafamostat combined with unfractionated heparin for anticoagulation

Intervention Type DRUG

Heparin

unfractionated heparin for anticoagulation

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No