Safety and Efficacy of Argatroban Applicated in Anticoagulation of V-V ECMO

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-06

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Unfractionated heparin is most common in the anticoagulation management of V-V ECMO. However, many side effects of unfractionated heparin, such as HIT, antithrombin deficiency, etc seriously affects the prognosis of patients. Argatroban is kind of direct thrombin inhibitors, which could be used used as an alternative anticoagulant of unfractionated heparin when HIT or antithrombin deficiency, etc. At present, there is no power enough evidence for the application of argatroban in V-V ECMO. This study aims to evaluat the safety and effectiveness of argatroban in the anticoagulation management of V-V ECMO compared with unfractionated heparin.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Feasibility of Argatroban As Anticoagulant in Adults with ECMO

NCT05226442

Extracorporeal Membrane Oxygenation Complication Anticoagulants and Bleeding Disorders

COMPLETED PHASE2/PHASE3

Comparing Anticoagulation Strategies Using UFH, Argatroban and LMWH for ECMO Support

NCT06442267

Respiratory Insufficiency Circulatory Failure Thromboembolism +1 more

RECRUITING PHASE4

Monitoring Anticoagulation in Patients on ECMO for Severe Lung Failure

NCT06038682

ARDS COVID-19

COMPLETED

Antithrombin Supplementation in ECMO

NCT03208270

Extracorporeal Membrane Oxygenation

COMPLETED PHASE2/PHASE3

New Anticoagulation Strategies of VV-ECMO

NCT03497338

Hemorrhage

WITHDRAWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

argatroban group

Patients received argatroban for anticoagulation during V-V ECMO.

Group Type EXPERIMENTAL

Argatroban

Intervention Type DRUG

Argatroban continuous intravenous injection maintained APTT at 1.5 times of baseline.

UFH group

Patients received UFH for anticoagulation during V-V ECMO.

Group Type ACTIVE_COMPARATOR

unfractionated heparin

Intervention Type DRUG

unfractionated heparin continuous intravenous injection maintained APTT at 1.5 times of baseline.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Argatroban

Argatroban continuous intravenous injection maintained APTT at 1.5 times of baseline.

Intervention Type DRUG

unfractionated heparin

unfractionated heparin continuous intravenous injection maintained APTT at 1.5 times of baseline.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Novastan

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age older than 18 years old; received V-V ECMO because of sevever respiratory failure

Exclusion Criteria

* anticoagulant contraindications; Confirmed or suspected, or previously diagnosed with heparin induced thrombocytopenia; Cerebral infarction or suspected patients; Patients with severe liver dysfunction; Allergic to heparin or argatroban; hemophilia; Unwilling or unable to complete the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No