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NCT05555641 | Recruiting | Critical Illness

Efficacy and Safety of Nafamostat Mesylate for VV-ECMO Anticoagulation
Sponsor:

ξOboyang, MD

Information provided by (Responsible Party):

ξOboyang, MD

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.

Condition or disease

Critical Illness

Anticoagulation

Intervention/treatment

Nafamostat Mesylate

Unfractionated Heparin

Phase

Phase 2

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.}}

Study Type : Interventional
Estimated Enrollment : 40 participants
Masking : Single
Primary Purpose : Treatment
Official Title : Efficacy and Safety of Nafamostat Mesylate for VV-ECMO Anticoagulation: a Randomized, Single-blind, Multicenter Exploratory, Heparin-controlled Trial
Actual Study Start Date : December 20, 2022
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : October 1, 2024
Arm Intervention/treatment

Experimental: Nafamostat Mesylate

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.

Drug: Nafamostat Mesylate

Active Comparator: Unfractionated Heparin

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.

Drug: Unfractionated Heparin
Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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;
Efficacy and Safety of Nafamostat Mesylate for VV-ECMO Anticoagulation

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Efficacy and Safety of Nafamostat Mesylate for VV-ECMO Anticoagulation

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Locations

Recruiting

China, Hubei

Wuhan Union Hospital

Wuhan, Hubei, China, 430022