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临床试验/NCT01653769
NCT01653769已完成不适用

CoSeal for Hemostasis of Aortic Anastomoses: A Propensity-Matched Cohort Study

Michael Reardon, MD1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
reduction in intra- and post-operative bleeding for procedures using CoSeal for hemostasis

研究概览

简要总结

Surgery on the aorta can be associated with significant blood loss. Most commonly this is due to bleeding at the site of aortic anastomosis. Surgical bleeding is associated with significant morbidity.

One way to prevent bleeding is to use a special glue (sealant) after performing large connections on the aorta. The goal of this study is to compare the different methods surgeons use to stop/prevent bleeding.

The study team will collect medical information about patients before, during, and after surgery on their aortas, including the methods used to prevent bleeding. This information may help doctors improve the way that they care for these patients.

详细描述

Bleeding is a major complication of cardiac surgery, and a significant cause of morbidity and mortality [1-4]. Hemostasis can be challenging during complex cardiac surgery, particularly due to friability of the tissue, coagulopathy, poor visualization of the surgical field, and limited accessibility to bleeding sites [5]. Failure to achieve and maintain hemostasis and reinforce fragile tissue may result in additional bleeding, which can further reduce visualization, increase operative blood loss, lengthen surgery, increase the use of blood products, and contribute to postoperative complications and reoperation [1-4].

Postoperative bleeding is a significant concern in cardio-thoracic surgery. Bleeding, either intraoperative or postoperative, has been associated with extended in-hospital length of stay, reoperations, severe morbidity and death [12]. In addition to surgical technique, a variety of therapeutic agents are available to assist in hemostasis. Surgical sealants are used to prevent suture line bleeding when ligation or conventional methods are ineffective or impractical [13]. CoSeal® Surgical Sealant (CoSeal®, Baxter, Westlake Village, CA) is a synthetic polyethylene glycol (PEG) polymer [11, 13]. The polymers cross-link with proteins in the tissue and begin to gel in approximately 5 seconds and set within 60 seconds, forming a strong, flexible, clear, degradable hydrogel that adheres to both tissue and synthetic graft surfaces [11, 13-14]. A secure seal is maintained through covalent tissue bonds even under high pressures in vessels, such as the aorta [15]. The gel is completely resorbed within 30 days [14].

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • The study will include all patients undergoing cardio-thoracic surgery requiring a large aortic anastomosis.

排除标准

  • Patients with severe preoperative coagulopathy, connective tissue disorders and disseminated intravascular coagulopathy (DIC) will be excluded.

结局指标

主要结局

reduction in intra- and post-operative bleeding for procedures using CoSeal for hemostasis

时间窗: from day of surgery to 15-30 days after discharge

estimated blood loss/chest drain output; blood product requirement during surgery; re-operation for bleeding

次要结局

  • decrease length of stay(participants will be followed for the duration of hospital stay, an expected average of 2 weeks)

研究者

发起方
Michael Reardon, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michael Reardon, MD

Sponsor-Investigator/Principal Investigator

The Methodist Hospital Research Institute

研究点 (1)

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