CoSeal for Hemostasis of Aortic Anastamoses
|ClinicalTrials.gov Identifier: NCT01653769|
Recruitment Status : Completed
First Posted : July 31, 2012
Last Update Posted : January 18, 2018
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.
|Condition or disease|
|Surgical Bleeding Aneurysms Aortic Dissection|
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 . 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 . 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 . 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 . The gel is completely resorbed within 30 days .
|Study Type :||Observational|
|Actual Enrollment :||150 participants|
|Official Title:||CoSeal for Hemostasis of Aortic Anastomoses: A Propensity-Matched Cohort Study|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||December 2015|
- reduction in intra- and post-operative bleeding for procedures using CoSeal for hemostasis [ Time Frame: 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
- decrease length of stay [ Time Frame: 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
Biospecimen Retention: None Retained
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01653769
|United States, Texas|
|The Methodist Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michael Reardon, MD||The Methodist Hospital Department of Cardiovascular Surgery|