Clinical trial NCT06276010: Use of Nafamostat Mesilate for Anticoagulation in Patients With ECMO
Official title: Use of Nafamostat Mesilate for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation After Cardiac Surgery: Efficacy and Safety
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Extracorporeal Membrane Oxygenation Complication
Keywords: anticoagulation
nafamostat mesilate
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the effectiveness and safety of nafamostat mesilate compared with unfractionated heparin for anticoagulation in patients with ECMO after cardiac surgery.

Detailed description: Selecting patients who require systemic anticoagulation as the study subjects from patients undergoing extracorporeal membrane oxygenation assistance after cardiac surgery. Randomly divided into the nafamostat mesilate group and unfractionated heparin group. To evaluate the efficacy and safety of nafamostat mesilate by comparing the incidence of bleeding and thrombosis within the target anticoagulant level range between two groups of patients during ECMO

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old
2. VA-ECMO or VV-ECMO was accepted after cardiac surgery.
3. The ECMO treatment team believes that systemic anticoagulation is needed
4. Sign the informed consent form

Exclusion Criteria:

1. The researchers believe that there are other causes of active bleeding that are not suitable to participate in this study.
2. Long-term use of anticoagulants before establishment of ECMO
3. Antiplatelet drugs were used before the establishment of ECMO
4. Severe liver insufficiency
5. Connective tissue disease
6. There is a history of allergy to heparin or nemolastat mesylate.
7. Pregnant
8. Previous diagnosis of heparin-induced thrombocytopenia
9. Expect to die within 48 hours
10. ECPR

Primary outcomes:
measure: Incidence of thrombotic complications
timeFrame: Within 7 days after starting anticoagulant therapy
Secondary outcomes:
measure: Incidence of severe bleeding complications
timeFrame: Within 7 days after starting anticoagulant therapy
measure: Infusion volume of blood products
timeFrame: Within 7 days after starting anticoagulant therapy
measure: ACT qualified rate
timeFrame: Within 7 days after starting anticoagulant therapy
measure: Hospitalization mortality
timeFrame: 28 days
measure: The incidence of oxygenator dysfunction
timeFrame: Within 7 days after starting anticoagulant therapy
measure: Heparin-induced thrombocytopenia
timeFrame: Within 7 days after starting anticoagulant therapy
measure: Time to reach the target anticoagulant level for the first time
timeFrame: Within 7 days after starting anticoagulant therapy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: Zhongtao Du, MD
role: STUDY_CHAIR
References: