CoSeal for Hemostasis of Aortic Anastamoses
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/20/2018 |
| Start Date: | June 2012 |
| End Date: | December 2015 |
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.
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.
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].
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].
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.
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