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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nafamostat Mesylate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 14 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of thrombosis during ECMO | The ratio of the number of patients with thrombosis complication to the number of cases in each group. | Up to 14 days. |
| Bleeding-free days during ECMO | Days without bleeding complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| You Shang, Prof. | Contact | 008602785351607 | you_shanghust@163.com | |
| Xiaobo Yang, Prof. | Contact | 008602785351606 | want.tofly@aliyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan Union Hospital | Recruiting | Wuhan | Hubei | 430022 | China |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C032855 | nafamostat |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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|
| Unfractionated Heparin | Drug | 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. |
|
| Up to 14 days. |
| Oxygenator replacement frequency | Oxygenator replacement frequency and average number of replacements per patient; | 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. | 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. | 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. | 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. | Up to 28 days. |
| In-hospital mortality | The fatality rates of all enrolled patients in each group during hospitalization. | Through study completion, an average of 2 months. |
| Average length of ICU stay. | Average number of days in ICU for each group of patients. | 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 | Through study completion, an average of 2 months. |