Critical IllnessPhase 2NCT05555641
Efficacy and Safety of Nafamostat Mesylate for VV-ECMO Anticoagulation
A Phase 2 study testing Nafamostat Mesylate and Unfractionated Heparin in people with Critical Illness and Anticoagulation, run by Xiaobo Yang, MD at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critical Illness, Anticoagulation
- What is being tested?
- Nafamostat Mesylate and Unfractionated Heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2022to 1 Oct 2024
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wuhan Union Hospital
Wuhan, Hubei, 430022
Xuehui Gao, 13681540930, 2542907921@qq.com
About this study
Official title: Efficacy and Safety of Nafamostat Mesylate for VV-ECMO Anticoagulation: a Randomized, Single-blind, Multicenter Exploratory, Heparin-controlled Trial
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.
Read the 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.
- Conditions
- Critical Illness, Anticoagulation
- Being tested
- Nafamostat Mesylate, Unfractionated Heparin
- Keywords
- Extracorporeal Membrane Oxygenation, Nafamostat mesylate, Unfractionated heparin, Anticoagulation
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nafamostat MesylateDrug
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.
Unfractionated HeparinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Nafamostat Mesylate | Experimental | 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. Receives: Drug: Nafamostat Mesylate |
| Unfractionated Heparin | Active comparator | 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. Receives: Drug: Unfractionated Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 14 days.
Secondary outcomes (10)
Incidence of thrombosis during ECMO
The ratio of the number of patients with thrombosis complication to the number of cases in each group.
Measured: Up to 14 days.
Bleeding-free days during ECMO
Days without bleeding complications
Measured: Up to 14 days.
Oxygenator replacement frequency
Oxygenator replacement frequency and average number of replacements per patient;
Measured: Up to 14 days.
The incidence of ECMO dysfunction
The ratio of the number of cases with ECMO dysfunction in each group to the total number of cases.
Measured: Up to 14 days.
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.
Measured: Up to 14 days.
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.
Measured: Up to 14 days.
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.
Measured: Up to 28 days.
In-hospital mortality
The fatality rates of all enrolled patients in each group during hospitalization.
Measured: Through study completion, an average of 2 months.
Average length of ICU stay.
Average number of days in ICU for each group of patients.
Measured: Through study completion, an average of 2 months.
Average length of hospital stay
The mean of the total hospitalization days for each group of patients
Measured: Through study completion, an average of 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start20 Dec 2022
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaobo Yang, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaobo Yang, MD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555641
- Sponsor's protocol ID
- NMST20211022
- Status last verified
- Feb 2023
- First submitted
- 16 Sep 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided