CoSeal for Hemostasis of Aortic Anastamoses

Completed

• Conditions: Surgical Bleeding; Aneurysms; Aortic Dissection

• Registration Number: NCT01653769
• Lead Sponsor: Michael Reardon, MD

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 \[14\].

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-02
• Study First Submitted QC: 2012-07-27
• Study First Posted: 2012-07-31
• Primary Completion: 2015-08
• Study Completion: 2015-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-16
• Last Update Posted: 2018-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
decrease length of stay	participants will be followed for the duration of hospital stay, an expected average of 2 weeks	length of stay (LOS) in ICU, LOS in-hospital (admission to discharge); day of surgery to discharge

Trial Locations

Locations (1)

The Methodist Hospital; 🇺🇸 Houston, Texas, United States