Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation

Efficacy and Safety of Bivalirudin Versus Heparin in Anticoagulant Therapy of ECMO: a Randomized Controlled Trial

The purpose of this study was to evaluate the efficacy and safety of bivalirudin in anticoagulation therapy in patients with extracorporeal membrane oxygenation (ECMO) compared with unfractionated heparin.

Study Overview

• Status: Not yet recruiting
• Conditions: Extracorporeal Membrane Oxygenation Complication
• Intervention / Treatment: Drug: bivalirudin; Drug: unfractionated heparin

Detailed Description

Patients with ECMO who needed systemic anticoagulation were randomly divided into bivalirudin group and unfractionated heparin group;the efficacy of bivalirudin in ECMO anticoagulation was evaluated by comparing the percentage of time within the target anticoagulation level and the incidence of thrombotic complications between the two groups during ECMO; and the safety of bivalirudin in ECMO anticoagulation was evaluated by comparing bleeding complications, blood product infusion and the incidence of acute renal failure between the two groups.

• Study Type: Interventional
• Enrollment (Estimated): 154
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaotong Hou, MD; Phone Number: 010-64456631; Email: xt.hou@ccmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Beijing Anzhen Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years old
2. Accept VA-ECMO or VV-ECMO
3. the ECMO team believes that systemic anticoagulation is necessary and that APTT should be maintained at 50-70s.
4. sign the informed consent form

Exclusion Criteria:

1. previous history of allergy to heparin or bivalirudin
2. previous diagnosis of heparin-induced thrombocytopenia.
3. the pre-random ECMO assistance time is more than 48 hours.
4. pregnant female
5. have participated in this study before.
6. the researchers believe that there are other factors that are not suitable to participate in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: bivalirudin group; If the creatinine clearance rate > 30ml/min, the initial dose of bivalirudin is 0.04mg/kg/h. If the creatinine clearance rate<30ml/min or the patients who have received renal replacement therapy (CRRT), the initial dose of bivalirudin is 0.02mg/kg/h, and the dose is adjusted according to APPT to maintain APTT at 50-70s. After bivalirudin started, APTT was checked every 4 hours. If APTT was in the target range twice in a row, it was re-examined every 12 hours.	Drug: bivalirudin; bivalirudin as an anticoagulant
Other: unfractionated heparin group; The initial dose of heparin was 8-12U/kg/h, and the dosage of heparin was adjusted according to the value of APTT. APTT was maintained at 50-70s, and APTT was reexamined every 4 hours.	Drug: unfractionated heparin; unfractionated heparin as an anticoagulant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
thrombotic complications	main end point of efficacy	Within seven days after starting anticoagulant therapy
bleeding complications	main safety endpoint	Within seven days after starting anticoagulant therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization mortality	All-cause death	28 days
Loop replacement		Within seven days after starting anticoagulant therapy
Infusion volume of blood products	Plasma, platelets and red blood cells	Within seven days after starting anticoagulant therapy
Acute renal failure	Incidence rate	Within seven days after starting anticoagulant therapy
Heparin-induced thrombocytopenia	Incidence rate	Within seven days after starting anticoagulant therapy
the time of reaching the target anticoagulant level for the first time		Within seven days after starting anticoagulant therapy
Percentage of time during ECMO within the target anticoagulant level	APTT maintained at 50-70s	Within seven days after starting anticoagulant therapy

Collaborators and Investigators

• Sponsor: Xiaotong Hou
• Investigators: Study Chair: Liangshan Wang, MD, Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 17, 2024
• First Submitted That Met QC Criteria: February 17, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Heparin; Bivalirudin; Calcium heparin
• Other Study ID Numbers: 2023-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No