CoSeal for Hemostasis of Aortic Anastamoses

NCT ID: NCT01653769

Last Updated: 2018-01-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-12-31

Brief Summary

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.

Detailed Description

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].

Conditions

Surgical Bleeding; Aneurysms; Aortic Dissection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Methodist Hospital Research Institute

OTHER

Sponsor Role: collaborator

Michael Reardon, MD

OTHER

Sponsor Role: lead

Responsible Party

Michael Reardon, MD

Sponsor-Investigator/Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael Reardon, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Department of Cardiovascular Surgery

Locations

The Methodist Hospital

Houston, Texas, United States

Countries

United States

Other Identifiers

IRB(2)0312-0064

Identifier Type: OTHER

Identifier Source: secondary_id

BS11-000639

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00007251

Identifier Type: -

Identifier Source: org_study_id