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

Primary Purpose

Respiratory Failure

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Argatroban

unfractionated heparin

About this trial

This is an interventional treatment trial for Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Bing SunRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

argatroban group

UFH group

Arm Description

Patients received argatroban for anticoagulation during V-V ECMO.

Patients received UFH for anticoagulation during V-V ECMO.

Outcomes

Primary Outcome Measures

incidence of ECMO related thrombotic events

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04925167

First Posted

June 11, 2021

Last Updated

November 8, 2022

Sponsor

Beijing Chao Yang Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04925167

Brief Title

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

Official Title

Safety and Efficacy of Argatroban Applicated in Anticoagulation of V-V ECMO: A Randomized Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 6, 2021 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Chao Yang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Randomized

Enrollment

174 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

argatroban group

Arm Type

Experimental

Arm Description

Patients received argatroban for anticoagulation during V-V ECMO.

Arm Title

UFH group

Arm Type

Active Comparator

Arm Description

Patients received UFH for anticoagulation during V-V ECMO.

Intervention Type

Drug

Intervention Name(s)

Argatroban

Other Intervention Name(s)

Novastan

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

unfractionated heparin

Intervention Description

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

Primary Outcome Measure Information:

Title

incidence of ECMO related thrombotic events

Description

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

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bing Sun, MD

Phone

+8613911151075

ricusunbing@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bing Sun, MD

Organizational Affiliation

Beijing Chao Yang Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bing Sun

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100020

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bing Sun, MD

Phone

+8613911151075

ricusunbing@126.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Study protocal, statistical analysis plan, informed consent form and clinical study report will be shared.

IPD Sharing Time Frame

1 year after the study completed.

IPD Sharing Access Criteria

Contact PI by email with reasonable reasons.

Learn more about this trial

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

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