Extracorporeal Membrane Oxygenation ComplicationNCT06276010
Use of Nafamostat Mesilate for Anticoagulation in Patients With ECMO
A study testing nafamostat mesilate and unfractionated heparin group in people with Extracorporeal Membrane Oxygenation Complication, run by Xiaotong Hou at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of nafamostat mesilate compared with unfractionated heparin for anticoagulation in patients with ECMO after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Membrane Oxygenation Complication
- What is being tested?
- nafamostat mesilate and unfractionated heparin group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 31 Dec 2026
- 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
- Age ≥ 18 years old
- VA-ECMO or VV-ECMO was accepted after cardiac surgery.
- The ECMO treatment team believes that systemic anticoagulation is needed
- Sign the informed consent form
Who cannot join
- The researchers believe that there are other causes of active bleeding that are not suitable to participate in this study.
- Long-term use of anticoagulants before establishment of ECMO
- Antiplatelet drugs were used before the establishment of ECMO
- Severe liver insufficiency
- Connective tissue disease
- There is a history of allergy to heparin or nemolastat mesylate.
Show all 10Show fewer
- Pregnant
- Previous diagnosis of heparin-induced thrombocytopenia
- Expect to die within 48 hours
- ECPR
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Zhongtao Du, MD, 86-18610846901, zhongtaodu@126.com
About this study
Official title: Use of Nafamostat Mesilate for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation After Cardiac Surgery: Efficacy and Safety
The purpose of this study is to evaluate the effectiveness and safety of nafamostat mesilate compared with unfractionated heparin for anticoagulation in patients with ECMO after cardiac surgery.
Read the detailed description
Selecting patients who require systemic anticoagulation as the study subjects from patients undergoing extracorporeal membrane oxygenation assistance after cardiac surgery. Randomly divided into the nafamostat mesilate group and unfractionated heparin group. To evaluate the efficacy and safety of nafamostat mesilate by comparing the incidence of bleeding and thrombosis within the target anticoagulant level range between two groups of patients during ECMO
- Being tested
- nafamostat mesilate, unfractionated heparin group
- Keywords
- anticoagulation, nafamostat mesilate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nafamostat mesilateDrug
Use nafamostat mesilate as an anticoagulant
unfractionated heparin groupDrug
Use unfractionated heparin as an anticoagulant
| Study group | Role | What they receive |
|---|---|---|
| nafamostat mesilate group | Experimental | The initial dosing of the nafamostat mesilate group is 0.5mg/kg/h. We maintain ACT at 180~220s by adjusting the dosage of nafamostat mesilate. Receives: Drug: nafamostat mesilate |
| unfractionated heparin group | Other | The initial dosing of the unfractionated heparin group is 8~12U/kg/h. We maintain ACT at 180~220s by adjusting the dosage of unfractionated heparin . Receives: Drug: unfractionated heparin group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of thrombotic complications
Thrombotic events include loop thrombosis, oxygenator thrombosis, venous thromboembolism, arterial thromboembolism, and cerebral infarction.
Measured: Within 7 days after starting anticoagulant therapy
Secondary outcomes (7)
Incidence of severe bleeding complications
The definition of bleeding event refers to ELSO Anticoagulation Guideline.
Measured: Within 7 days after starting anticoagulant therapy
Infusion volume of blood products
After randomization, suspended red blood cells, plasma, fibrinogen and platelet volume were infused per person per ECMO day.
Measured: Within 7 days after starting anticoagulant therapy
ACT qualified rate
Number of times ACT detection reached the standard / total number of tests during ECMO
Measured: Within 7 days after starting anticoagulant therapy
Hospitalization mortality
All-cause mortality
Measured: 28 days
The incidence of oxygenator dysfunction
incidence
Measured: Within 7 days after starting anticoagulant therapy
Heparin-induced thrombocytopenia
incidence
Measured: Within 7 days after starting anticoagulant therapy
Time to reach the target anticoagulant level for the first time
Measured: Within 7 days after starting anticoagulant therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start1 Jul 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Membrane Oxygenation ComplicationStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaotong Hou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaotong Hou, Beijing Anzhen Hospital
- Investigators
- Zhongtao Du, MD, Study chair, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276010
- Sponsor's protocol ID
- 2023-102
- Status last verified
- Sep 2025
- First submitted
- 16 Feb 2024
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Nafamostat Mesilate for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation After Cardiac Surgery: Efficacy and Safety
- ClinicalTrials.gov ID
- NCT06276010
- Acronym / sponsor ID
- 2023-102
- Keywords
- anticoagulation, nafamostat mesilate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Xiaotong HouUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Feb 2024 (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 purpose of this study is to evaluate the effectiveness and safety of nafamostat mesilate compared with unfractionated heparin for anticoagulation in patients with ECMO after cardiac surgery.
Detailed description
Selecting patients who require systemic anticoagulation as the study subjects from patients undergoing extracorporeal membrane oxygenation assistance after cardiac surgery. Randomly divided into the nafamostat mesilate group and unfractionated heparin group. To evaluate the efficacy and safety of nafamostat mesilate by comparing the incidence of bleeding and thrombosis within the target anticoagulant level range between two groups of patients during ECMO
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nafamostat mesilate group | Experimental | Drug: nafamostat mesilateThe initial dosing of the nafamostat mesilate group is 0.5mg/kg/h. We maintain ACT at 180~220s by adjusting the dosage of nafamostat mesilate. |
| unfractionated heparin group | Other | Drug: unfractionated heparin groupThe initial dosing of the unfractionated heparin group is 8~12U/kg/h. We maintain ACT at 180~220s by adjusting the dosage of unfractionated heparin . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- VA-ECMO or VV-ECMO was accepted after cardiac surgery.
- The ECMO treatment team believes that systemic anticoagulation is needed
- Sign the informed consent form
Key exclusion criteria (10 listed)
- The researchers believe that there are other causes of active bleeding that are not suitable to participate in this study.
- Long-term use of anticoagulants before establishment of ECMO
- Antiplatelet drugs were used before the establishment of ECMO
- Severe liver insufficiency
- Connective tissue disease
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 mesilateUse nafamostat mesilate as an anticoagulant | Drug | nafamostat mesilate group |
| unfractionated heparin groupUse unfractionated heparin as an anticoagulant | Drug | unfractionated heparin group |
Primary outcome
Incidence of thrombotic complications
Time frame: Within 7 days after starting anticoagulant therapy
Thrombotic events include loop thrombosis, oxygenator thrombosis, venous thromboembolism, arterial thromboembolism, and cerebral infarction.
7 secondary outcomes
Incidence of severe bleeding complications
Time frame: Within 7 days after starting anticoagulant therapy
Infusion volume of blood products
Time frame: Within 7 days after starting anticoagulant therapy
ACT qualified rate
Time frame: Within 7 days after starting anticoagulant therapy
Hospitalization mortality
Time frame: 28 days
The incidence of oxygenator dysfunction
Time frame: Within 7 days after starting anticoagulant therapy
Heparin-induced thrombocytopenia
Time frame: Within 7 days after starting anticoagulant therapy
Time to reach the target anticoagulant level for the first time
Time frame: Within 7 days after starting anticoagulant therapy
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 25 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Zhongtao Du, MD study chair
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nafamostat mesilate and unfractionated heparin group in people with Extracorporeal Membrane Oxygenation Complication, run by Xiaotong Hou at 1 site in China.
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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Xiaotong Hou, MD (010-64456631, xt.hou@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of thrombotic complications (time frame: Within 7 days after starting anticoagulant therapy). 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 25 Sep 2025.