CoSeal for Hemostasis of Aortic Anastamoses

Aortic Dissection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01653769
• Other study ID #: Pro00007251
• Secondary ID: IRB(2)0312-0064B
• Status: Completed
• Phase: N/A
• First received: July 2, 2012
• Last updated: January 16, 2018
• Start date: June 2012
• Est. completion date: December 2015

Study information

• Verified date: January 2018
• Source: The Methodist Hospital System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aneurysms
• Aortic Dissection
• Hemorrhage
• Surgical Bleeding

Locations

Country	Name	City	State
United States	The Methodist Hospital	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Michael Reardon, MD	The Methodist Hospital System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction in intra- and post-operative bleeding for procedures using CoSeal for hemostasis	estimated blood loss/chest drain output; blood product requirement during surgery; re-operation for bleeding	from day of surgery to 15-30 days after discharge
Secondary	decrease length of stay	length of stay (LOS) in ICU, LOS in-hospital (admission to discharge); day of surgery to discharge	participants will be followed for the duration of hospital stay, an expected average of 2 weeks