Back to resultsEfficacy and Safety of Nafamostat Mesylate for VV-ECMO Anticoagulation
Primary Purpose
Critical Illness, Anticoagulation
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Nafamostat Mesylate
Unfractionated Heparin
Sponsored by
About this trial
This is an interventional treatment trial for Critical Illness focused on measuring Extracorporeal Membrane Oxygenation, Nafamostat mesylate, Unfractionated heparin, Anticoagulation
Eligibility Criteria
Inclusion Criteria:
- Patients aged >= 18 and <= 75 years;
- Successfully established ECMO (VA/VV) treatment by percutaneous puncture due to cardiogenic shock or respiratory failure;
- Anticoagulation required during ECMO treatment; Before the establishment of ECMO, the APTT test value was within the normal range, and the platelets were not less than 80G/L;
- Within 48 hours of ECMO establishment, APTT test results were between 1 and 1.75 times the upper limit of normal, PLT>80 G/L, and no serious bleeding and thrombosis;
- Sign the informed consent.
Exclusion Criteria:
- Pregnant;
- Bleeding risk or active bleeding;
- Pre-existing diseases requiring long-term anticoagulation before ECMO: pulmonary embolism, deep vein thrombosis, intraventricular thrombosis, atrial fibrillation, etc.;
- Long-term use of anticoagulants before ECMO;
- Antiplatelet drugs were used before ECMO;
- Allergy to heparin, nafamostat mesylate;
- Repeated puncture at the same site for more than 3 times;
- Expected ECMO treatment time < 3 days;
- Patients with an expected survival period of less than 48 hours;
- Patients undergoing extracorporeal cardiopulmonary resuscitation;
- Burn patients; Blood purification treatment using polyacrylonitrile membrane filter;
- Heterozygous ECMO mode or ECMO therapy solely for CO2 removal;
- Other reasons that the investigator considers inappropriate for inclusion;
Sites / Locations
- Wuhan Union HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nafamostat Mesylate
Unfractionated Heparin
Arm Description
VV-ECMO patients were given continuous anticoagulation with nafamostat mesylate, coagulation function was monitored every 6 hours, and APTT was maintained at 1-1.75 times the upper limit of normal detection until reaching the study endpoints, including 14 days after enrollment, 24 hours after withdrawal from ECMO, or any switch to ECMO mode during ECMO treatment.
VV-ECMO patients were given continuous anticoagulation with unfractionated heparin, coagulation function was monitored every 6 hours, and APTT was maintained at 1-1.75 times the upper limit of normal detection until reaching the study endpoints, including 14 days after enrollment, 24 hours after withdrawal from ECMO, or any switch to ECMO mode during ECMO treatment.
Outcomes
Primary Outcome Measures
Incidence of severe bleeding during ECMO
The ratio of the number of patients with severe bleeding complications to the total number of cases in each group.
Secondary Outcome Measures
Incidence of thrombosis during ECMO
The ratio of the number of patients with thrombosis complication to the number of cases in each group.
Bleeding-free days during ECMO
Days without bleeding complications
Oxygenator replacement frequency
Oxygenator replacement frequency and average number of replacements per patient;
The incidence of ECMO dysfunction
The ratio of the number of cases with ECMO dysfunction in each group to the total number of cases.
The average amount of red, plasma, cryoprecipitate, fibrinogen, and platelets per person per ECMO day
Average blood transfusion volume per ECMO day, including red blood cells, plasma, cryoprecipitate, fibrinogen, and platelets.
The compliance rate of APTT test results
The ratio of the number of APTT tests that met the requirements to the total number of APTT tests during ECMO.
Case fatality rate within 28 days
After follow-up, the fatality rates of all enrolled patients in each group within 28 days of the study began.
In-hospital mortality
The fatality rates of all enrolled patients in each group during hospitalization.
Average length of ICU stay.
Average number of days in ICU for each group of patients.
Average length of hospital stay
The mean of the total hospitalization days for each group of patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05555641
Brief Title
Efficacy and Safety of Nafamostat Mesylate for VV-ECMO Anticoagulation
Official Title
Efficacy and Safety of Nafamostat Mesylate for VV-ECMO Anticoagulation: a Randomized, Single-blind, Multicenter Exploratory, Heparin-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiaobo Yang, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study was to compare the efficacy and safety of nafamostat mesylate and unfractionated heparin during ECMO anticoagulation in critically ill patients.
Detailed Description
During ECMO treatment, nafamostat mesylate and unfractionated heparin were randomly administered for continuous anticoagulation, respectively, and the incidence of bleeding and thrombotic complications during anticoagulation was compared between the two groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Anticoagulation
Keywords
Extracorporeal Membrane Oxygenation, Nafamostat mesylate, Unfractionated heparin, Anticoagulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nafamostat Mesylate
Arm Type
Experimental
Arm Description
VV-ECMO patients were given continuous anticoagulation with nafamostat mesylate, coagulation function was monitored every 6 hours, and APTT was maintained at 1-1.75 times the upper limit of normal detection until reaching the study endpoints, including 14 days after enrollment, 24 hours after withdrawal from ECMO, or any switch to ECMO mode during ECMO treatment.
Arm Title
Unfractionated Heparin
Arm Type
Active Comparator
Arm Description
VV-ECMO patients were given continuous anticoagulation with unfractionated heparin, coagulation function was monitored every 6 hours, and APTT was maintained at 1-1.75 times the upper limit of normal detection until reaching the study endpoints, including 14 days after enrollment, 24 hours after withdrawal from ECMO, or any switch to ECMO mode during ECMO treatment.
Intervention Type
Drug
Intervention Name(s)
Nafamostat Mesylate
Intervention Description
ECMO patients were given continuous anticoagulation with nafamostat mesylate, coagulation function was monitored every 6 hours, and APTT was maintained at 1-1.75 times the upper limit of normal detection until reaching the study endpoints, including 14 days after enrollment, 24 hours after withdrawal from ECMO, or any switch to ECMO mode during ECMO treatment.
Intervention Type
Drug
Intervention Name(s)
Unfractionated Heparin
Intervention Description
ECMO patients were given continuous anticoagulation with unfractionated heparin, coagulation function was monitored every 6 hours, and APTT was maintained at 1-1.75 times the upper limit of normal detection until reaching the study endpoints, including 14 days after enrollment, 24 hours after withdrawal from ECMO, or any switch to ECMO mode during ECMO treatment.
Primary Outcome Measure Information:
Title
Incidence of severe bleeding during ECMO
Description
The ratio of the number of patients with severe bleeding complications to the total number of cases in each group.
Time Frame
Up to 14 days.
Secondary Outcome Measure Information:
Title
Incidence of thrombosis during ECMO
Description
The ratio of the number of patients with thrombosis complication to the number of cases in each group.
Time Frame
Up to 14 days.
Title
Bleeding-free days during ECMO
Description
Days without bleeding complications
Time Frame
Up to 14 days.
Title
Oxygenator replacement frequency
Description
Oxygenator replacement frequency and average number of replacements per patient;
Time Frame
Up to 14 days.
Title
The incidence of ECMO dysfunction
Description
The ratio of the number of cases with ECMO dysfunction in each group to the total number of cases.
Time Frame
Up to 14 days.
Title
The average amount of red, plasma, cryoprecipitate, fibrinogen, and platelets per person per ECMO day
Description
Average blood transfusion volume per ECMO day, including red blood cells, plasma, cryoprecipitate, fibrinogen, and platelets.
Time Frame
Up to 14 days.
Title
The compliance rate of APTT test results
Description
The ratio of the number of APTT tests that met the requirements to the total number of APTT tests during ECMO.
Time Frame
Up to 14 days.
Title
Case fatality rate within 28 days
Description
After follow-up, the fatality rates of all enrolled patients in each group within 28 days of the study began.
Time Frame
Up to 28 days.
Title
In-hospital mortality
Description
The fatality rates of all enrolled patients in each group during hospitalization.
Time Frame
Through study completion, an average of 2 months.
Title
Average length of ICU stay.
Description
Average number of days in ICU for each group of patients.
Time Frame
Through study completion, an average of 2 months.
Title
Average length of hospital stay
Description
The mean of the total hospitalization days for each group of patients
Time Frame
Through study completion, an average of 2 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged >= 18 and <= 80 years;
Successfully established ECMO (VA/VV) treatment by percutaneous puncture due to cardiogenic shock or respiratory failure;
Anticoagulation required during ECMO treatment; Before the establishment of ECMO, the APTT test value was within the normal range, and the platelets were not less than 80G/L;
Within 48 hours of ECMO establishment, APTT test results were between 1 and 1.75 times the upper limit of normal, PLT>80 G/L, and no serious bleeding and thrombosis;
Sign the informed consent.
Exclusion Criteria:
Pregnant;
Bleeding risk or active bleeding;
Pre-existing diseases requiring long-term anticoagulation before ECMO: pulmonary embolism, deep vein thrombosis, intraventricular thrombosis, atrial fibrillation, etc.;
Long-term use of anticoagulants before ECMO;
Antiplatelet drugs were used before ECMO;
Allergy to heparin, nafamostat mesylate;
Repeated puncture at the same site for more than 3 times;
Expected ECMO treatment time < 3 days;
Patients with an expected survival period of less than 48 hours;
Patients undergoing extracorporeal cardiopulmonary resuscitation;
Burn patients; Blood purification treatment using polyacrylonitrile membrane filter;
Heterozygous ECMO mode or ECMO therapy solely for CO2 removal;
Other reasons that the investigator considers inappropriate for inclusion;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
You Shang, Prof.
Phone
008602785351607
Email
you_shanghust@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaobo Yang, Prof.
Phone
008602785351606
Email
want.tofly@aliyun.com
Facility Information:
Facility Name
Wuhan Union Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuehui Gao
Phone
13681540930
Email
2542907921@qq.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy and Safety of Nafamostat Mesylate for VV-ECMO Anticoagulation
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