Sepsis-induced Coagulopathy (SIC)NCT06994312
The Impact of Nafamostat Mesylate on the Prognosis of Patients With Sepsis-Induced Coagulopathy Undergoing Hemofiltration
A study testing Nafamostat Mesylate and sodium citrate in people with Sepsis-induced Coagulopathy (SIC), run by The First Hospital of Jilin University.
Trial summary
In sepsis, the body is prone to coagulation system disorders, which may progress to sepsis-induced coagulopathy (SIC). When SIC is persistent and cannot be corrected, it often sequentially develops into disseminated intravascular coagulation (DIC) with multiple organ failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis-induced Coagulopathy (SIC)
- What is being tested?
- Nafamostat Mesylate and sodium citrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (Age ≥ 18 years);
- Patients with SIC Undergoing Hemofiltration.
Who cannot join
- Individuals under the age of 18, pregnant women, and breastfeeding mothers;
- Patients with a history of high sensitivity to nafamostat mesylate (those who have experienced significant bleeding complications from previous use of nafamostat mesylate);
- Fibrinogen < 1.5 g/L;
- Patients with bleeding or high risk of bleeding:
- Those in the acute phase of trauma or with active bleeding (e.g., flail chest, obvious contusions of the lungs, liver, spleen, retroperitoneal bleeding, pelvic fractures, etc.); Those with a history of severe head trauma, intracranial surgery, stroke, cerebral aneurysm, or arteriovenous malformation within one month prior to enrollment; Those with a history of congenital bleeding disorders: such as hemophilia; Those with underlying fulminant hepatitis, decompensated cirrhosis, or other severe liver diseases.
About this study
Official title: The Impact of Nafamostat Mesylate on the Prognosis of Patients With Sepsis-Induced Coagulopathy Undergoing Hemofiltration：A Single-Center, Prospective, Randomized Controlled Trial
In sepsis, the body is prone to coagulation system disorders, which may progress to sepsis-induced coagulopathy (SIC). When SIC is persistent and cannot be corrected, it often sequentially develops into disseminated intravascular coagulation (DIC) with multiple organ failure. Nafamostat mesylate can be used as an anticoagulant during blood purification in critically ill patients and is also used to treat SIC.Safe and effective anticoagulation is a prerequisite for the success of blood purification therapy. For patients with active bleeding or at risk of bleeding, how to achieve extracorporeal anticoagulation without affecting the body's coagulation function is a major clinical challenge. Nafamostat mesylate can reduce the risk of bleeding during blood purification, but its impact on the survival outcomes of patients with SIC undergoing blood purification therapy remains unclear.The aim of this study is to evaluate the impact of nafamostat mesylate treatment on the prognosis of patients with sepsis-induced coagulopathy undergoing hemofiltration.
- Conditions
- Sepsis-induced Coagulopathy (SIC)
- Being tested
- Nafamostat Mesylate, sodium citrate
- Keywords
- Single-Center, Prospective, Randomized Controlled Trial, sepsis-induced coagulopathy (SIC), Nafamostat Mesylate, Prognosis, Hemofiltration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nafamostat MesylateDrug
Also called Experimental Group
Anticoagulation with Nafamostat Mesylate for SIC Patients Undergoing Hemofiltration
sodium citrateDrug
Also called Control Group
Anticoagulation with Sodium Citrate for SIC Patients Undergoing Hemofiltration
| Study group | Role | What they receive |
|---|---|---|
| Nafamostat Mesylate Group | Experimental | Nafamostat mesylate (50 mg/vial, Jiangsu DuRui Pharmaceutical Co., Ltd.) is dissolved and prepared with 5% glucose injection solution. It is continuously infused through the anticoagulant injection tube at the start of hemofiltration, with an initial dose generally ranging from 20 to 50 mg/h. Monitoring is performed before treatment and within 2 to 4 hours after the start of treatment. In cases of active bleeding, moderate to high bleeding risk, hypercoagulable state, or high-dose use of nafamostat mesylate (NM), the monitoring frequency should be increased (e.g., every 4 to 6 hours). After the treatment becomes stable, the monitoring interval can be extended to 12 to 24 hours. The activated clotting time (ACT) or activated partial thromboplastin time (APTT) at the post-dialyzer or venous end should be maintained at 1.5 to 2.5 times the pre-treatment level, or the ACT should be maintained between 150 and 250 seconds, and the APTT between 50 and 70 seconds. Receives: Drug: Nafamostat Mesylate |
| Sodium Citrate Group | Active comparator | Patients were continuously infused with sodium citrate (200 ml/bag, Chengdu Qingshanlikang Pharmaceutical Co., Ltd.). The initial pump rate of 4% sodium citrate was set at 2.1% of the blood flow rate, and the initial pump rate of 10% calcium gluconate was set at 7.3% of the flow rate of 4% sodium citrate. Adjust the doses of sodium citrate and calcium gluconate based on the levels of ionized calcium in arterial and venous blood gases.The goal is to maintain arterial blood ionized calcium levels at 1.00-1.20 mmol/L and venous blood ionized calcium levels at 0.21-0.40 mmol/L. Receives: Drug: sodium citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Mortality Rates
The proportion of patients who died during the ICU stay out of the total number of patients in the group.
Measured: Through study completion, an average of 1 year
Secondary outcomes (4)
Average Filter Lifespan
The total sum of all filter usage times for each patient divided by the number of filters used.
Measured: Through study completion, an average of 1 year
ICU length of stay
Length of Stay in the ICU
Measured: Through study completion, an average of 1 year
28-day mortality
The proportion of patients who died within 28 days out of the total number of patients in the group.
Measured: Through study completion, an average of 1 year
Incidence of Bleeding
The proportion of patients experiencing bleeding events (such as cerebral hemorrhage, gastrointestinal bleeding, etc.) during the ICU stay out of the total number of patients.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis-induced Coagulopathy (SIC)Studies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994312
- Sponsor's protocol ID
- Yuting Li 20250430
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Nafamostat Mesylate on the Prognosis of Patients With Sepsis-Induced Coagulopathy Undergoing Hemofiltration：A Single-Center, Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06994312
- Acronym / sponsor ID
- Yuting Li 20250430
- Conditions
- Sepsis-induced Coagulopathy (SIC)
- Keywords
- Single-Center, Prospective, Randomized Controlled Trial, sepsis-induced coagulopathy (SIC), Nafamostat Mesylate, Prognosis, Hemofiltration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 29 May 2025 (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.
In sepsis, the body is prone to coagulation system disorders, which may progress to sepsis-induced coagulopathy (SIC). When SIC is persistent and cannot be corrected, it often sequentially develops into disseminated intravascular coagulation (DIC) with multiple organ failure. Nafamostat mesylate can be used as an anticoagulant during blood purification in critically ill patients and is also used to treat SIC.Safe and effective anticoagulation is a prerequisite for the success of blood purification therapy. For patients with active bleeding or at risk of bleeding, how to achieve extracorporeal anticoagulation without affecting the body's coagulation function is a major clinical challenge. Nafamostat mesylate can reduce the risk of bleeding during blood purification, but its impact on the survival outcomes of patients with SIC undergoing blood purification therapy remains unclear.The aim of this study is to evaluate the impact of nafamostat mesylate treatment on the prognosis of patients with sepsis-induced coagulopathy undergoing hemofiltration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nafamostat Mesylate Group | Experimental | Drug: Nafamostat MesylateNafamostat mesylate (50 mg/vial, Jiangsu DuRui Pharmaceutical Co., Ltd.) is dissolved and prepared with 5% glucose injection solution. It is continuously infused through the anticoagulant injection tube at the start of hemofiltration, with an initial dose generally ranging from 20 to 50 mg/h. Monitoring is performed before treatment and within 2 to 4 hours after the start of treatment. In cases of active bleeding, moderate to high bleeding risk, hypercoagulable state, or high-dose use of nafamostat mesylate (NM), the monitoring frequency should be increased (e.g., every 4 to 6 hours). After the treatment becomes stable, the monitoring interval can be extended to 12 to 24 hours. The activated clotting time (ACT) or activated partial thromboplastin time (APTT) at the post-dialyzer or venous end should be maintained at 1.5 to 2.5 times the pre-treatment level, or the ACT should be maintained between 150 and 250 seconds, and the APTT between 50 and 70 seconds. |
| Sodium Citrate Group | Active comparator | Drug: sodium citratePatients were continuously infused with sodium citrate (200 ml/bag, Chengdu Qingshanlikang Pharmaceutical Co., Ltd.). The initial pump rate of 4% sodium citrate was set at 2.1% of the blood flow rate, and the initial pump rate of 10% calcium gluconate was set at 7.3% of the flow rate of 4% sodium citrate. Adjust the doses of sodium citrate and calcium gluconate based on the levels of ionized calcium in arterial and venous blood gases.The goal is to maintain arterial blood ionized calcium levels at 1.00-1.20 mmol/L and venous blood ionized calcium levels at 0.21-0.40 mmol/L. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (Age ≥ 18 years);
- Patients with SIC Undergoing Hemofiltration.
Key exclusion criteria (5 listed)
- Individuals under the age of 18, pregnant women, and breastfeeding mothers;
- Patients with a history of high sensitivity to nafamostat mesylate (those who have experienced significant bleeding complications from previous use of nafamostat mesylate);
- Fibrinogen < 1.5 g/L;
- Patients with bleeding or high risk of bleeding:
- Those in the acute phase of trauma or with active bleeding (e.g., flail chest, obvious contusions of the lungs, liver, spleen, retroperitoneal bleeding, pelvic fractures, etc.); Those with a history of severe head trauma, intracranial surgery, stroke, cerebral aneurysm, or arteriovenous malformation within one month prior to enrollment; Those with a history of congenital bleeding disorders: such as hemophilia; Those with underlying fulminant hepatitis, decompensated cirrhosis, or other severe liver diseases.
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 MesylateAlso: Experimental GroupAnticoagulation with Nafamostat Mesylate for SIC Patients Undergoing Hemofiltration | Drug | Nafamostat Mesylate Group |
| sodium citrateAlso: Control GroupAnticoagulation with Sodium Citrate for SIC Patients Undergoing Hemofiltration | Drug | Sodium Citrate Group |
Primary outcome
ICU Mortality Rates
Time frame: Through study completion, an average of 1 year
The proportion of patients who died during the ICU stay out of the total number of patients in the group.
4 secondary outcomes
Average Filter Lifespan
Time frame: Through study completion, an average of 1 year
ICU length of stay
Time frame: Through study completion, an average of 1 year
28-day mortality
Time frame: Through study completion, an average of 1 year
Incidence of Bleeding
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nafamostat Mesylate and sodium citrate in people with Sepsis-induced Coagulopathy (SIC), run by The First Hospital of Jilin University.
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 5 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: opening soon, as of the sponsor's last update on 29 May 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU Mortality Rates (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2025.