The AutoloGel™ Post-Market Surveillance (TAPS) Program
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Cytomedix
- 入组人数
- 131
- 试验地点
- 4
- 主要终点
- Assess the incidence of hematological immunologic other ae's association with the application of AutoloGel on exuding wounds such as leg ulcers pressure ulcers and diabetics ulcers and during the management of mechanically or surgically debrided wounds
研究概览
简要总结
AutoloGel™ Post-Market Surveillance Program
Purpose:Evaluate the incidence of hematologic and immunologic adverse events, including coagulopathies in patients with wounds to which AutoloGel™ was applied.
Design:Prospective, open label, patient registry. Investigator Sites: 3 Enrollment Size: 300
Subject Population: Patients with exuding wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and for the management of mechanically or surgically-debrided wounds.
Primary Objective Safety: Assess the incidence of hematologic (coagulopathies), immunologic (including anaphylaxis) and other adverse events associated with the application of AutoloGel on exuding wounds, such as leg ulcers, pressure ulcers and diabetic ulcers and during the management of mechanically or surgically-debrided wounds.
Primary Safety Endpoint: Absence of coagulopathies caused by inhibitors to coagulation Factor V as determined by a significant prolongation of the prothrombin (PT) time and confirmed by severe depletion of Factor V activity with a positive Bethesda Assay for anti-Factor V functional inhibitors.
详细描述
Device Name.
The device subject to the Post-Market Surveillance (PMS) Program is the AutoloGel™ System which has been cleared for marketing by the Food and Drug Administration (FDA) in the application BK060007.
The AutoloGel™ System includes.
AutoloGel™ Centrifuge II AutoloGel™ System Wound Dressing and Reagent Kits including single-use, disposable components for performing a patient phlebotomy, centrifuging blood to derive PRP and activating and applying the AutoloGel.
The Instructions for Use include a detailed description and procedures for making AutoloGel and a list of the Kit components which is provided at the end of the Instructions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A patient who meets all the following criteria will be enrolled in the postmarket surveillance program:
- •Presents with exuding wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and mechanically or surgically-debrided wounds.
- •Male or female subject of any race, and 18 to 95 years old.
排除标准
- •Study investigator(s) shall follow the Contraindications, Precautions, and Warnings relevant to subjects enrolled for treatment of wounds;
- •Subjects will be excluded from the trial if any of the following criteria are met:
- •If the Subject is on Coumadin medication (or another medication that is known to affect a potential coagulopathy) and has an elevated PT (prothrombin time) at the alert level at baseline, he/she will NOT be enrolled in the surveillance program.
- •Ensure the patient does not have any Contraindications as noted in the AutoloGel System Instructions for use, specifically:
- •Patients known to be sensitive to components and / or materials of bovine origin
- •Patients on chemotherapeutic agents
- •Patients with the following abnormal laboratory test levels
- •hemoglobin <10.5 g/dL
- •platelet count <100 x 109/L
- •serum albumin level < 2.5 g/dL
- •Wounds due to malignancy
- •Wounds with active clinically diagnosed infection
结局指标
主要结局
Assess the incidence of hematological immunologic other ae's association with the application of AutoloGel on exuding wounds such as leg ulcers pressure ulcers and diabetics ulcers and during the management of mechanically or surgically debrided wounds
时间窗: 3 years
次要结局
- Absence of coagulopathies caused by inhibitors to coagulation Factor V as determined by a significant prolongation of the (PT) time. Depletion of Factor V activity with a positive Bethesda Assay(3 years)