Use of Nafamostat Mesilate for Anticoagulation in Patients With ECMO
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: nafamostat mesilate, unfractionated heparin group.
- Who it may be relevant to
- Registry conditions: Extracorporeal Membrane Oxygenation Complication. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Use of Nafamostat Mesilate for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation After Cardiac Surgery: Efficacy and Safety
Overview
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
Interventions
- Drug nafamostat mesilate
Use nafamostat mesilate as an anticoagulant - Drug unfractionated heparin group
Use unfractionated heparin as an anticoagulant
Primary outcome measures
- Incidence of thrombotic complications [Time frame: Within 7 days after starting anticoagulant therapy]
Secondary outcome measures (7)
- Incidence of severe bleeding complications [Time frame: Within 7 days after starting anticoagulant therapy]
- Infusion volume of blood products [Time frame: Within 7 days after starting anticoagulant therapy]
- ACT qualified rate [Time frame: Within 7 days after starting anticoagulant therapy]
- Hospitalization mortality [Time frame: 28 days]
- The incidence of oxygenator dysfunction [Time frame: Within 7 days after starting anticoagulant therapy]
- Heparin-induced thrombocytopenia [Time frame: Within 7 days after starting anticoagulant therapy]
- Time to reach the target anticoagulant level for the first time [Time frame: Within 7 days after starting anticoagulant therapy]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years old
- VA-ECMO or VV-ECMO was accepted after cardiac surgery.
- The ECMO treatment team believes that systemic anticoagulation is needed
- Sign the informed consent form
Exclusion criteria
- The researchers believe that there are other causes of active bleeding that are not suitable to participate in this study.
- Long-term use of anticoagulants before establishment of ECMO
- Antiplatelet drugs were used before the establishment of ECMO
- Severe liver insufficiency
- Connective tissue disease
- There is a history of allergy to heparin or nemolastat mesylate.
- Pregnant
- Previous diagnosis of heparin-induced thrombocytopenia
- Expect to die within 48 hours
- ECPR
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
China · 1 center
- Beijing Anzhen Hospital — Beijing
Identifiers
NCT: NCT06276010 · 2023-102