DRUG
bivalirudin
bivalirudin as an anticoagulant
Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation
Status
Recruiting
Phase
Not applicable
Enrollment
154
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
DRUG
unfractionated heparin
unfractionated heparin as an anticoagulant
Timeline
From registration to results.
First posted
Feb 23, 2024
Study start
Jun 3, 2024
Primary completion
Dec 31, 2026
Study completion
Mar 1, 2027
Results posted
Not reported
Registry updated
Apr 6, 2026
Outcomes
What the study measures.
Primary outcomes
thrombotic complications
Time frame · Within seven days after starting anticoagulant therapy
main end point of efficacy
bleeding complications
Time frame · Within seven days after starting anticoagulant therapy
main safety endpoint
Secondary outcomes
Hospitalization mortality
Time frame · 28 days
All-cause death
Loop replacement
Time frame · Within seven days after starting anticoagulant therapy
Infusion volume of blood products
Time frame · Within seven days after starting anticoagulant therapy
Plasma, platelets and red blood cells
Acute renal failure
Time frame · Within seven days after starting anticoagulant therapy
Incidence rate
Heparin-induced thrombocytopenia
Time frame · Within seven days after starting anticoagulant therapy
Incidence rate
the time of reaching the target anticoagulant level for the first time
Time frame · Within seven days after starting anticoagulant therapy
Percentage of time during ECMO within the target anticoagulant level
Time frame · Within seven days after starting anticoagulant therapy
APTT maintained at 40-60s
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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 40-60s. 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 locations
1 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Bivalirudin.
NCT IDStudyPhase / statusEnrollmentUpdated
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Duke University · Coronavirus Infection (COVID-19) · Pulmonary Arterial Hypertension
Not applicable
Recruiting
5,000
2026-07
BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation
Sydney Local Health District · Extracorporeal Membrane Oxygenation Complication
Phase 2
Recruiting
80
2026-05
Bivalirudin Versus Heparin During PCI in High Bleeding Risk Patients With Acute Coronary Syndromes
Shenyang Northern Hospital · Percutaneous Coronary Intervention · High Bleeding Risk
Phase 4
Not yet recruiting
5,270
2026-02
Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System
Stanford University · Heart Failure · Cardiogenic Shock
Phase 2
Recruiting
50
2026-01
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
NYU Langone Health · Coronary Microvascular Disease · Ischemic Heart Disease
Not applicable
Active, not recruiting
206
2025-11
Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During Emergency PCI
Shenyang Northern Hospital · ST Elevation Myocardial Infarction
Not applicable
Completed
6,016
2025-08
A Study on the Impact of Bivalirudin Usage During PCI for High-risk Plaques on Post-PCI Coronary Microcirculation.
Peking University First Hospital · Coronary Microvascular Dysfunction
Phase 4
Recruiting
70
2025-08
Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation
Boston Children's Hospital · Drug Effect
Not applicable
Recruiting
30
2025-07
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.