SepsisPhase 4NMSICRCTNCT06078839
Nafamostat Mesilate in the Treatment of Severe Infection-associated Coagulopathy
A Phase 4 study testing Nafamostat mesilate and 5% glucose in people with Sepsis and Sepsis-induced Coagulopathy, run by Xu Li.
Trial summary
The objective of this study was to evaluate the therapeutic effect of nafamostat mesilate on patients with severe infection-related coagulation。 Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sepsis, Sepsis-induced Coagulopathy, Nafamostat Mesilate
- What is being tested?
- Nafamostat mesilate and 5% glucose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 778 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Oct 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meets the criteria for sepsis 3.0".
- Targeted population for SIC anticoagulant therapy（http://research-kudo-prediction.s3-website-ap-northeast-1.amazonaws.com/）
Who cannot join
- Age less than 18, pregnant women, and lactating women
- Patients with a history of hypersensitivity to nafamostat mesilate (previous use of nafamostat mesilate resulted in significant bleeding complications)
- Fibrinogen < 1.5g/L
- Patients with bleeding or high bleeding risk Patients in the acute phase of trauma or with active bleeding (such as flail chest, significant contusions of the lungs, liver, kidneys, spleen, retroperitoneal bleeding, pelvic fractures, etc.) History of severe traumatic brain injury, intracranial surgery, stroke, cerebral aneurysm, or arteriovenous malformation within the past month prior to enrollment Patients with a history of congenital bleeding disorders (such as hemophilia) Patients with underlying fulminant hepatitis, decompensated cirrhosis, or other severe liver diseases
- Patients receiving the following medications Patients who have received heparin and heparin analogs (including low molecular weight heparin, dalteparin, etc.) within the past 12 hours prior to treatment Patients who have received warfarin within the past 7 days prior to the study and have an INR level above normal Patients who have undergone thrombolytic therapy within the past 3 days prior to the study Patients who have received platelet inhibitors (such as aspirin, clopidogrel, ticlopidine, dipyridamole, etc.) within the past 7 days prior to the study Patients currently receiving other novel anticoagulant medications (such as Xa factor inhibitors like apixaban, rivaroxaban, edoxaban, etc., direct thrombin inhibitors like dabigatran
- ICU treatment time is expected to be no more than 24h
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- Patients who have undergone cardiopulmonary resuscitation within the past 7 days prior to the study
- Patients who have participated in other studies within the 30 days prior to enrollment
- Due to irreversible disease states, such as advanced malignant tumors or other end-stage diseases; or patients in a terminal state deemed by the physician to be approaching death
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Nafamostat Mesilate in the Treatment of Severe Infection-associated Coagulopathy: a Multicenter Randomized Controlled Trial
The objective of this study was to evaluate the therapeutic effect of nafamostat mesilate on patients with severe infection-related coagulation。
- Conditions
- Sepsis, Sepsis-induced Coagulopathy, Nafamostat Mesilate
- Being tested
- Nafamostat mesilate, 5% glucose
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nafamostat mesilateDrug
Nafamostat mesilate treatment group was dissolved with 5% glucose at the dosage of 2.0mg/kg/ day to a total of 50ml(Maximum concentration 10mg/ml)
5% glucoseDrug
Add 50ml of 5% glucose into a 50ml syringe
| Study group | Role | What they receive |
|---|---|---|
| Placebo control group | Placebo comparator | Not described Receives: Drug: 5% glucose |
| Nafamostat mesilate treatment group (experimental group) | Experimental | Not described Receives: Drug: Nafamostat mesilate |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality in ICU
Measured: 7 days
Secondary outcomes (4)
Improvement in organ function (SOFA score)
Measured: 7 days
DIC score (JAAM/ISTH score) changes;
Measured: 7 days
28-day all-cause fatality rate
Measured: 28-day
Adverse event rate
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Nafamostat mesilate treatment group (experimental group) : Basic treatment + Nafamostat mesilate 2.0 mg/kg/d Placebo control group: Basic treatment + 5% glucose with Nafamostat mesilate equal volume
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 778 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xu Li
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Third Central Hospital, Tianjin Medical University General Hospital, Shanxi Provincial People's Hospital, Shanxi Bethune Hospital, Hohhot First Hospital, Jilin University, Northern Jiangsu People's Hospital, Affiliated Hospital of Nantong University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Suzhou Medical, Anhui Provincial Hospital, Zhejiang Hospital, Zhejiang Provincial People's Hospital, The First Affiliated Hospital of Ningbo, The First Affiliated Hospital of Wenzhou, Jiangxi Provincial People's Hopital, First Affiliated Hospital of Gannan Medical University, Second Affiliated Hospital of Xi'an Jiaotong University, LanZhou University, The First Affiliated Hospital of Xinjiang, First Affiliated Hospital of Xinjiang Medical University, Tongji Medical College of Huazhong University, The Second Hospital University of South China, The Fourth Affiliated Hospital of China Medical, The First Affiliated Hospital of Liaoning, Genertec Liaoyou Gem Flower Hospital, The Tenth People's Hospital of Shenyang, Shenyang Sixth People's Hospital, Dalian NO.3 People's Hospital, Benxi Cental Hospital, Liaoyang City Central Hospital, Huludao central hospital
- Responsible party
- Sponsor-investigator, Xu Li, First Hospital of China Medical University
- Investigators
- Xu Li, Phd, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078839
- Sponsor's protocol ID
- AF-0G-03-1.1-02
- Acronym
- NMSICRCT
- Status last verified
- Oct 2023
- First submitted
- 20 Sep 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang H, Feng J, Ma Y, Ma X, Li X; EASNMS investigators. Efficacy and safety of nafamostat mesilate for sepsis (EASNMS): study protocol for a multicenter randomized controlled trial. Trials. 2025 Jul 29;26(1):262. doi: 10.1186/s13063-025-08979-4.
PubMed 40731293
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nafamostat Mesilate in the Treatment of Severe Infection-associated Coagulopathy: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06078839
- Acronym / sponsor ID
- NMSICRCT / AF-0G-03-1.1-02
- Conditions
- Sepsis, Sepsis-induced Coagulopathy, Nafamostat Mesilate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 778 participants (estimated)
- Lead sponsor
- Xu LiUniversity, hospital or other
- Collaborators
- Tianjin Third Central Hospital, Tianjin Medical University General Hospital, Shanxi Provincial People's Hospital, Shanxi Bethune Hospital, Hohhot First Hospital, Jilin University, Northern Jiangsu People's Hospital, Affiliated Hospital of Nantong University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Suzhou Medical, Anhui Provincial Hospital, Zhejiang Hospital, Zhejiang Provincial People's Hospital, The First Affiliated Hospital of Ningbo, The First Affiliated Hospital of Wenzhou, Jiangxi Provincial People's Hopital, First Affiliated Hospital of Gannan Medical University, Second Affiliated Hospital of Xi'an Jiaotong University, LanZhou University, The First Affiliated Hospital of Xinjiang, First Affiliated Hospital of Xinjiang Medical University, Tongji Medical College of Huazhong University, The Second Hospital University of South China, The Fourth Affiliated Hospital of China Medical, The First Affiliated Hospital of Liaoning, Genertec Liaoyou Gem Flower Hospital, The Tenth People's Hospital of Shenyang, Shenyang Sixth People's Hospital, Dalian NO.3 People's Hospital, Benxi Cental Hospital, Liaoyang City Central Hospital, Huludao central hospital
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study was to evaluate the therapeutic effect of nafamostat mesilate on patients with severe infection-related coagulation。
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Nafamostat mesilate treatment group (experimental group) : Basic treatment + Nafamostat mesilate 2.0 mg/kg/d Placebo control group: Basic treatment + 5% glucose with Nafamostat mesilate equal volume
| Arm | Type | Receives |
|---|---|---|
| Placebo control group | Placebo comparator | Drug: 5% glucose |
| Nafamostat mesilate treatment group (experimental group) | Experimental | Drug: Nafamostat mesilate |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- meets the criteria for sepsis 3.0".
- Targeted population for SIC anticoagulant therapy（http://research-kudo-prediction.s3-website-ap-northeast-1.amazonaws.com/）
Key exclusion criteria (9 listed)
- Age less than 18, pregnant women, and lactating women
- Patients with a history of hypersensitivity to nafamostat mesilate (previous use of nafamostat mesilate resulted in significant bleeding complications)
- Fibrinogen < 1.5g/L
- Patients with bleeding or high bleeding risk Patients in the acute phase of trauma or with active bleeding (such as flail chest, significant contusions of the lungs, liver, kidneys, spleen, retroperitoneal bleeding, pelvic fractures, etc.) History of severe traumatic brain injury, intracranial surgery, stroke, cerebral aneurysm, or arteriovenous malformation within the past month prior to enrollment Patients with a history of congenital bleeding disorders (such as hemophilia) Patients with underlying fulminant hepatitis, decompensated cirrhosis, or other severe liver diseases
- Patients receiving the following medications Patients who have received heparin and heparin analogs (including low molecular weight heparin, dalteparin, etc.) within the past 12 hours prior to treatment Patients who have received warfarin within the past 7 days prior to the study and have an INR level above normal Patients who have undergone thrombolytic therapy within the past 3 days prior to the study Patients who have received platelet inhibitors (such as aspirin, clopidogrel, ticlopidine, dipyridamole, etc.) within the past 7 days prior to the study Patients currently receiving other novel anticoagulant medications (such as Xa factor inhibitors like apixaban, rivaroxaban, edoxaban, etc., direct thrombin inhibitors like dabigatran
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nafamostat mesilateNafamostat mesilate treatment group was dissolved with 5% glucose at the dosage of 2.0mg/kg/ day to a total of 50ml(Maximum concentration 10mg/ml) | Drug | Nafamostat mesilate treatment group (experimental group) |
| 5% glucoseAdd 50ml of 5% glucose into a 50ml syringe | Drug | Placebo control group |
Primary outcome
All-cause mortality in ICU
Time frame: 7 days
4 secondary outcomes
Improvement in organ function (SOFA score)
Time frame: 7 days
DIC score (JAAM/ISTH score) changes;
Time frame: 7 days
28-day all-cause fatality rate
Time frame: 28-day
Adverse event rate
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Derived from this study: PubMed 40731293Yang H, Feng J, Ma Y, Ma X, Li X; EASNMS investigators. Efficacy and safety of nafamostat mesilate for sepsis (EASNMS): study protocol for a multicenter randomized controlled trial. Trials. 2025 Jul 29;26(1):262. doi: 10.1186/s13063-025-08979-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xu Li, Phd principal investigator
First Hospital of China Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nafamostat mesilate and 5% glucose in people with Sepsis and Sepsis-induced Coagulopathy, run by Xu Li.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xu Li, Phd (+8613604059359, vincentzh002@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality in ICU (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06078839, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.