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

NCT04925167 | Completed

• 1 other identifier: Argatroban in V-V ECMO
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• incidence of ECMO related thrombotic events

  the incidence of ECMO related thrombotic events, such as membrane oxygenator or tube thrombosis.

  14 days

Study Arms (2)

argatroban group

EXPERIMENTAL

Patients received argatroban for anticoagulation during V-V ECMO.

Drug: Argatroban

UFH group

ACTIVE COMPARATOR

Patients received UFH for anticoagulation during V-V ECMO.

Drug: unfractionated heparin

Interventions

Argatroban DRUG

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

Also known as: Novastan

argatroban group

unfractionated heparin DRUG

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

UFH group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Bing Sun

Beijing, Beijing Municipality, 100020, China

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

argatroban; Heparin

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Bing Sun, MD

  Beijing Chao Yang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 14, 2021
• Study Start: July 6, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 1 year after the study completed.
• Access Criteria: Contact PI by email with reasonable reasons.

Locations

CN (1)