NCT06078839尚未招募4 期
Nafamostat Mesilate in the Treatment of Severe Infection-associated Coagulopathy: a Multicenter Randomized Controlled Trial
Xu Li0 个研究点目标入组 778 人开始时间: 2023年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 778
- 主要终点
- All-cause mortality in ICU
研究概览
简要总结
The objective of this study was to evaluate the therapeutic effect of nafamostat mesilate on patients with severe infection-related coagulation。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •meets the criteria for sepsis 3.0".
- •Targeted population for SIC anticoagulant therapy（http://research-kudo-prediction.s3-website-ap-northeast-1.amazonaws.com/）
排除标准
- •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
- •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
研究组 & 干预措施
Placebo control group
Placebo Comparator
干预措施: 5% glucose (Drug)
Nafamostat mesilate treatment group (experimental group)
Experimental
干预措施: Nafamostat mesilate (Drug)
结局指标
主要结局
All-cause mortality in ICU
时间窗: 7 days
次要结局
- DIC score (JAAM/ISTH score) changes;(7 days)
- Improvement in organ function (SOFA score)(7 days)
- 28-day all-cause fatality rate(28-day)
- Adverse event rate(7 days)
研究者
Xu Li
Professor
First Hospital of China Medical University
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