Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation

Not Applicable

Not yet recruiting

• Conditions: Extracorporeal Membrane Oxygenation Complication
• Interventions: Drug: bivalirudin; Drug: unfractionated heparin

• Registration Number: NCT06275555
• Lead Sponsor: Xiaotong Hou

Brief 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.

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 Timeline

• Study First Submitted: 2024-02-17
• Study First Submitted QC: 2024-02-17
• Study First Posted: 2024-02-23
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-19
• Study Start: 2024-08-01
• Primary Completion: 2025-03-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 154

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bivalirudin group	bivalirudin	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 40-60s. 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.
unfractionated heparin group	unfractionated heparin	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 40-60s, and APTT was reexamined every 4 hours.

Primary Outcome Measures

Name	Time	Method
thrombotic complications	Within seven days after starting anticoagulant therapy	main end point of efficacy
bleeding complications	Within seven days after starting anticoagulant therapy	main safety endpoint

Secondary Outcome Measures

Name	Time	Method
Acute renal failure	Within seven days after starting anticoagulant therapy	Incidence rate
Percentage of time during ECMO within the target anticoagulant level	Within seven days after starting anticoagulant therapy	APTT maintained at 40-60s
Infusion volume of blood products	Within seven days after starting anticoagulant therapy	Plasma, platelets and red blood cells
Heparin-induced thrombocytopenia	Within seven days after starting anticoagulant therapy	Incidence rate
the time of reaching the target anticoagulant level for the first time	Within seven days after starting anticoagulant therapy
Hospitalization mortality	28 days	All-cause death
Loop replacement	Within seven days after starting anticoagulant therapy

Trial Locations

Locations (1)

Beijing Anzhen Hospital; 🇨🇳 Beijing, Beijing, China