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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 8
- 主要终点
- To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ...
研究概览
简要总结
The Study investigates a new product, sFilm-FS, aimed to help controlling body fluid leakage in general surgery procedures, proposing its use as an adjunct to hemostasis and/or sealing.
详细描述
Many products have been developed as adjuncts to hemostasis in bleeding situations where traditional methods such as suture, clips or energy-based coagulation are ineffective or impractical.
Many products are not as effective in the presence of active and/or brisk bleeding since the lack of sufficient adhesion strength allows forceful bleeding to simply "float" the products away from the bleeding tissue, prior to the achievement of full hemostasis.
The Study investigates a new product, sFilm-FS, aimed to help the control of body fluid leakage in general surgery procedures, proposing its use as an adjunct to hemostasis and/or sealing.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (males or females) aged ≥ 18 years old.
- •Patients requiring elective open hepatic surgery.
- •Hemoglobin ≥ 8.0 g/dL within 24 hours prior to surgical procedure.
- •Patients understanding the nature of the study and providing their informed consent prior to participation.
- •Patients willing to participate in the study and able to attend the visits and procedures foreseen by study protocol.
- •Intra-operative inclusion criteria:
- •Patients with a target bleeding site (TBS) identified by the Investigator during hepatic surgery (intra-operative inclusion criteria).
排除标准
- •Patients having undergone a therapeutic surgical procedure within 30 days from the study enrolment.
- •Patients with a severe coagulopathy defined as INR > 2.
- •Patients with platelet count <50,000 x109 PLT/L at the screening.
- •Patients admitted to trauma surgery.
- •Transplant patients due to fulminant hepatic failure.
- •Patients with known or suspected allergy or hypersensitivity to blood products or to one of the components of sFilm-FS or the active-comparator.
- •Patients with anesthesia risk judged to be higher than ASA3 by the Investigator.
- •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 abusers.
- •Patients suffering from claustrophobia.
- •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.
- •Patients being treated with at least one of the following treatments: antibiotic therapy for active infection, fibrin sealants, systemic steroids, or immunosuppressive agents.
- •Patients who are participating or have participated in other clinical studies within the 30 days before the study enrolment.
- •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.
- •Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception.
- •Intra-operative exclusion criteria:
- •Patients identified with a TBS with major arterial bleeding requiring suture or mechanical ligation.
- •Patients identified by the Investigator to have intra-operative bleeding from large defects in large arteries or veins, requiring repair.
- •Patients identified by the Investigator to have intra-operative findings that may preclude conduct of study procedure.
- •Patients having an active local infection in the anatomic surgical area.
- •Patients with occurrence of major intra-operative complications that require resuscitation or deviation from the planned surgical procedure.
- •Patients with bleeding site in or near to foramina in bone.
结局指标
主要结局
To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ...
时间窗: From visit 1 to visit 9 (an average of 6.5 months)
Incidence of Treatment-Emergent Adverse Events AEs related to bleeding at TBS, thrombotic events, transfusion-related complications, post-operative adhesions (MRI assessment)
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through Physical Examinations
时间窗: From visit 1 to visit 9 (an average of 6.5 months)
Safety will be assessed from randomization of patients until the last follow-up visit by physical examination: the detection of the number of patients with at least one clinical abnormality in different body areas (abdomen, eyes, skin, cardiovascular)
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values
时间窗: From visit 1 to visit 9 (an average of 6.5 months)
Safety will be assessed from randomization of patients until the last follow-up visit by urine analysis (pH)
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Detection of Antibodies Against Fibrinogen.
时间窗: Last Follow-Up Visit (Visit 9)
Safety will be assessed from randomization of patients until the last follow-up visit by Measuring plasma levels of antibodies against human fibrinogen, by performing a screening assay using bridging ELISA based on polyclonal antibodies against human fibrinogen, which was developed with a sensitivity of 1000 ng/ml. Patients whose results were above 1000ng/ml control were considered positive.
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
时间窗: From visit 1 to visit 9 (an average of 6.5 months)
Safety will be assessed from randomization of patients until the last follow-up visit by measuring Systolic Blood Pressure (mmHg)
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
时间窗: From visit 1 to visit 9 (an average of 6.5 months)
Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Hemoglobin (g/L))
次要结局
- To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Proportion of Patients Achieving Hemostasis at TBS(Day of surgery)
- To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Incidence of Re-treatment at the TBS(Day of surgery)
- To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Percentage of Total Patients That Have Achieved Hemostasis(Day of surgery)
- To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through Incidence of Treatment Failure(Day of surgery)
- To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure.(From surgery, up to 6 months)