EUCTR2018-000434-34-SI进行中（未招募）1 期
A Phase I/II, randomized, prospective, controlled, multi-center, open-label, two arm study evaluating the safety and preliminary efficacy of sFilm-FS in controlling liver bleeding during elective surgery.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients (males or females) aged = 18 years old.
- •2. Patients requiring elective surgery in which liver
- •bleeding will be encountered..
- •3. Hemoglobin = 8.0 g/dL within 24 hours prior to surgical procedure.
- •4. Patients understanding the nature of the study and providing their informed consent prior to participation.
- •5. Patients willing to participate in the study and able to attend the
- •visits and procedures foreseen by study protocol.
- •Intra-operative inclusion criteria:
- •6. Patients with a target bleeding site (TBS) identified by the
- •Investigator during surgery in which liver bleeding will be
- •encountered.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Patients having undergone a therapeutic surgical procedure within 30 days from the study enrolment.
- •2. Patients with a severe coagulopathy defined as INR > 2.0.
- •3. Patients with platelet count <50,000 x109 PLT/L at the screening.
- •4. Patients admitted to trauma surgery.
- •5. Transplant patients due to fulminant hepatic failure.
- •6. Patients with known or suspected allergy or hypersensitivity to
- •blood products or to one of the components of sFilm-FS or the
- •active-comparator.
- •7. Patients with anesthesia risk judged to be higher than ASA3 by the
- •Investigator.
- •8. Patients with at least one of the following concomitant conditions:
- •severe co-morbid conditions known to pose a high risk for surgery
- •and adequate recovery (i.e. liver cirrhosis with Child-Pugh score B
- •or C, cholestasis, heart diseases), immunodeficiency diseases, blood
- •clotting disorders, any conditions known to effect wound healing
- •(i.e. collagen vascular disease), known or current alcohol or drug
- •9. Patients suffering from claustrophobia.
- •10. Patients with implanted or embedded metal objects, prostheses,
- •pacemaker, or fragments in the head or body that would present a risk
- •during the MRI scanning procedure or have worked with ferrous
- •metals either as a vocation or hobby or following trauma (i.e., sheet
- •metal workers, welders, or machinists) in such a way that might have
- •led to unknown, indwelling metal fragments that could cause injury if
- •they moved in response to placement in the magnetic field.
- •11. Patients being treated with at least one of the following treatments:
- •antibiotic therapy for active infection, fibrin sealants, systemic
- •steroids or immunosuppressive agents.
- •12. Patients who are participating or have participated in other clinical
- •studies within the 30 days before the study enrolment.
- •13. Female patients who are pregnant or breast-feeding or who wish to
- •become pregnant during the period of the clinical study and for three
- •months later.
- •14. Female patients of childbearing age (less than 24 months after the
- •last menstrual cycle) who do not use adequate contraception. *
- •Intra-operative exclusion criteria:
- •15. Patients identified with a TBS with major arterial bleeding requiring
- •suture or mechanical ligation.
- •16. Patients identified by the Investigator to have intra-operative
- •bleeding from large defects in large arteries or veins, requiring
- •17. Patients identified by the Investigator to have intra-operative
- •findings that may preclude conduct of study procedure.
- •18. Patients having an active local infection in the anatomic surgical area.
- •19. Patients with occurrence of major intra-operative complications that require resuscitation or deviation from the planned surgical
- •20. Patients with bleeding site in or near to foramina in bone.
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