CoSeal for Hemostasis of Aortic Anastamoses

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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Dissection; Aneurysms; Surgical Bleeding

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 Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects for this study will be selected from patients undergoing cardio-thoracic surgery requiring a large aortic anastomosis. Both the retrospective and prospective study components will review the data of all procedures requiring a large aortic anastomosis in order to compare those in which CoSeal® was used versus other materials/techniques.

For the retrospective arm of the study, pre-existing data will be collected from the patient's medical records under a HIPAA Waiver of Authorization. For the prospective arm of the study, patients will provide consent to collect their data.

Approximately 150 patients will be enrolled in this study. Specifically, consecutive potential subjects will be evaluated for participation in this study according to the inclusion and exclusion criteria.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Michael Reardon, MD
• Collaborators: The Methodist Hospital Research Institute
• Investigators: Principal Investigator: Michael Reardon, MD, The Methodist Hospital Department of Cardiovascular Surgery

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 2, 2012
• First Submitted That Met QC Criteria: July 27, 2012
• First Posted (Estimate): July 31, 2012

Study Record Updates

• Last Update Posted (Actual): January 18, 2018
• Last Update Submitted That Met QC Criteria: January 16, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: bleeding; Cardiac surgery; hemostasis; Aortic Dissection; Aneurysms; CoSeal; Surgical bleeding; Aortic anastamoses
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hemorrhage; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: Pro00007251; IRB(2)0312-0064 (Other Identifier: TMHRI IRB); BS11-000639 (Other Identifier: Other ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share available data.