Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation

Extracorporeal Membrane Oxygenation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06275555
• Other study ID #: 2023-101
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Beijing Anzhen Hospital
• Contact: Xiaotong Hou, MD
• Phone: 010-64456631
• Email: xt.hou[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 154
• Est. completion date: December 31, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Extracorporeal Membrane Oxygenation Complication

Intervention

Drug:
• bivalirudin
bivalirudin as an anticoagulant
• unfractionated heparin
unfractionated heparin as an anticoagulant

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xiaotong Hou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thrombotic complications	main end point of efficacy	Within seven days after starting anticoagulant therapy
Primary	bleeding complications	main safety endpoint	Within seven days after starting anticoagulant therapy
Secondary	Hospitalization mortality	All-cause death	28 days
Secondary	Loop replacement		Within seven days after starting anticoagulant therapy
Secondary	Infusion volume of blood products	Plasma, platelets and red blood cells	Within seven days after starting anticoagulant therapy
Secondary	Acute renal failure	Incidence rate	Within seven days after starting anticoagulant therapy
Secondary	Heparin-induced thrombocytopenia	Incidence rate	Within seven days after starting anticoagulant therapy
Secondary	the time of reaching the target anticoagulant level for the first time		Within seven days after starting anticoagulant therapy
Secondary	Percentage of time during ECMO within the target anticoagulant level	APTT maintained at 50-70s	Within seven days after starting anticoagulant therapy