Safety and Feasibility of Argatroban as Anticoagulant in Adults With ECMO

Extracorporeal Membrane Oxygenation Complication Clinical Trial

Official title:

A Prospective Randomized Pilot Trial on Safety and Feasibility of Argatroban as Anticoagulant in Patients With Extracorporeal Membrane Oxygenation (ECMO)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05226442
• Other study ID #: Argatroban_ECMO
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: December 1, 2021
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: Medical University of Vienna
• Contact: Nina Buchtele, MD, PhD
• Phone: +431 40400 44900
• Email: nina.buchtele[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective, randomized, controlled pilot trial aims to assess the safety and feasibility of Argatroban as an alternative anticoagulant to unfractionated heparin in patients receiving extracorporeal membrane oxygenation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Minimum Age 18 years

• VV- or VA-ECMO therapy

• Minimum of 24h planned ECMO-therapy

Exclusion Criteria:

• History of Heparin-induced thrombocytopenia (HIT)

• High risk of bleeding, contraindication for anticoagulation (eg. active GI-bleeding, Intracerebral bleeding; Platelet count <50G/l, congenital bleeding disorder)

• Pregnancy

• Severe Liver disease (SOFA score liver domain 4 points = Bilirubin >12mg/dl)

• Postoperative admission

• Strong lupus anticoagulant or acquired intrinsic clotting factor deficiency at admission (APTT >50 sec without anticoagulation).

Related Conditions & MeSH terms

• Anticoagulants and Bleeding Disorders
• Blood Coagulation Disorders
• Extracorporeal Membrane Oxygenation Complication
• Hemostatic Disorders

Intervention

Drug:
• Argatroban
Argatroban is a synthetic, univalent DTI, that directly binds to the catalytic thrombin binding site exerting its effects
• Unfractionated heparin
Unfractionated heparin produces its major anticoagulant effect by inactivating thrombin and activated factor X (factor Xa) through an antithrombin (AT)-dependent mechanism.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Transfusion rate of packed red blood cells assessed as total units/ECMO day	Assessment of the total amount of units (250-300ml each) packed red blood cells transfused per ECMO day following a transfusion threshold of Hb<8g/dl	From date of randomization until the date of ECMO discontinuation, or death, whichever came first, assessed up to 120 days
Other	Grading of bleeding	According to the Bleeding Academic Research Consortium type 1 - 5 (Type 1: Bleeding that is not actionable; Type 2: Any clinically overt sign of hemorrhage that "is actionable" and requires diagnostic studies, hospitalization, or treatment by a health care professional; Type 3a. Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding; Type 3b. Overt bleeding plus hemoglobin drop < 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents; type 3c. Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision; Type 4: CABG-related bleeding within 48 hours; Type 5a. Probable fatal bleeding; Type 5b. Definite fatal bleeding (overt or autopsy or imaging confirmation)	From date of randomization until the date of ECMO discontinuation, or death, whichever came first, assessed up to 120 days
Other	Mortality rate at day 28/90	assessed by chart review or telephone call	Until 90 days after start of study drug administration
Primary	Bleeding and thrombosis with Argatroban compared to unfractionated Heparin (UFH)	Bleeding will be assessed continuously by the investigators according to the BARC bleeding classification, where bleeding type 2 or higher will be considered as clinically significant bleeding; outcome measures will be the incidence of clinically significant bleeding per ECMO day and time to first bleeding; thrombosis is defined as any occurence of thromboembolism including membrane lung exchange due to suspected thrombosis, pulmonary embolism or deep vein thrombosis; outcome measures will be the incidence of thromboembolism per ECMO day and the time to first thromboembolism	From date of randomization until the date of ECMO discontinuation, or death, whichever came first, assessed up to 120 days
Secondary	study enrollment, study completion and ability to achieve target values of Argatroban as anticoagulant in ECMO	ratio of screened to included patients, proportion of patients who completed the study according to the protocol, proportion of coagulation tests within range and total number of dose adjustments	From date of randomization until the date of ECMO discontinuation, or death, whichever came first, assessed up to 120 days