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CoSeal for Hemostasis of Aortic Anastamoses

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01653769
Enrollment
150
Registered
2012-07-31
Start date
2012-06-30
Completion date
2015-12-31
Last updated
2018-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysms, Aortic Dissection, Surgical Bleeding

Keywords

CoSeal, Surgical bleeding, hemostasis, Aortic anastamoses, bleeding, Cardiac surgery, Aneurysms, Aortic Dissection

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 \[14\].

Interventions

None listed

Sponsors

The Methodist Hospital Research Institute
CollaboratorOTHER
Michael Reardon, MD
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
reduction in intra- and post-operative bleeding for procedures using CoSeal for hemostasisfrom day of surgery to 15-30 days after dischargeestimated blood loss/chest drain output; blood product requirement during surgery; re-operation for bleeding

Secondary

MeasureTime frameDescription
decrease length of stayparticipants will be followed for the duration of hospital stay, an expected average of 2 weekslength of stay (LOS) in ICU, LOS in-hospital (admission to discharge); day of surgery to discharge

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026