NL-OMON51932已完成不适用
A phase I trial evaluating the safety, tolerability and pharmacokinetics of intravenously administered M6229 in critically ill sepsis patients - *HistoSeps* - HistoSeps
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male or female patients aged >= 18 year.
- •2. Signed informed consent by patient or legal representative.
- •3. Diagnosed with sepsis, defined by the Sepsis-3 criteria as a
- •life-threatening organ dysfunction caused by a dysregulated host response to an
- •4. The patients have to be included in the study within 72 hours of ICU
- •admission due to sepsis or within 72 hours after sepsis diagnosis on the ICU.
- •M6229 has to be administered within 84 hours after ICU admission due to sepsis
- •or within 84 hours after sepsis diagnosis on the ICU
排除标准
- •1. Subject has an advance directive to withhold life-sustaining treatments.
- •2. Subject is breastfeeding or intents to get pregnant within 30 days of
- •enrolling into the study.
- •3. Subject is of childbearing potential and has a positive pregnancy test.
- •a. A woman is considered to be of childbearing potential under the age of 60
- •years, unless surgically sterile.
- •4. Clinical suspicion or confirmation of a viral hemorrhagic shock syndrome
- •including, but not limited to, dengue fever.
- •5. Bleeding risk:
- •a. Clinical:
- •i. Active bleeding;
- •ii. Head trauma;
- •iii. Intracranial surgery or stroke in the past 3 months;
- •iv. History of intracerebral arteriovenous malformation, cerebral aneurysm or
- •mass lesions of the central nervous system;
- •v. Cerebral haemorrhage;
- •vi. History of a bleeding diatheses;
- •vii. Gastrointestinal bleeding in the past 6 weeks;
- •viii. Presence of an epidural or spinal catheter;
- •ix. Contraindication for IV therapeutic UFH.
- •b. Laboratory:
- •i. Platelet count <50 x109/L;
- •ii. INR >2.0;
- •iii. Baseline aPTT >=45 seconds prior to enrolment, 1.5x upper limit of normal
- •6. Use of any of the following treatments:
- •a. UFH to treat a thrombotic event within 12 hours before infusion;
- •b. LMWH within 24 hours before the infusion;
- •c. Warfarin (if used within 7 days before study entry AND if the INR
- •exceeds 2.0 at enrolment);
- •d. Direct oral anticoagulant (DOAC) use 3 days prior to enrollment.
- •e. Thrombolytic therapy within 3 previous days;
- •f. Use of IIb/IIIa inhibitors within the previous 7 days.
- •7. Confirmed antiphospholipid syndrome.
- •8. Known allergy to fish.
- •9. Cardiopulmonary resuscitation in the previous 7 days.
- •10. Liver failure defined as Child-Pugh Score Class C [19].
- •11. Abnormal liver function (ASAT and/or ALAT > 5 times upper limit of normal
- •12. Extracorporeal membrane oxygenation (ECMO) support dependent.
- •13. Pulmonary embolism or clinical suspicion of deep venous thrombosis (DVT).
- •14. Life expectancy of less than 24 hours.
- •15. Treating physician refusal.
- •16. Known adverse reaction to UFH, including heparin induced thrombocytopenia
- •17. Participation in any other investigational drug study or other
- •interventional study with interfering endpoints.
- •18. Any other clinical condition which, in the opinion of the investigator,
- •would not allow safe completion of the protocol.
研究者
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