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CoSeal for Hemostasis of Aortic Anastamoses

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: July 31, 2012
Last Update Posted: July 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
The Methodist Hospital System
July 2, 2012
July 31, 2012
July 1, 2016
June 2012
August 2015   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01653769 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
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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.

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].

Observational Model: Cohort
Not Provided
Retention:   None Retained
Time perspective is both retrospective and prospective.
Non-Probability Sample

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.

  • Surgical Bleeding
  • Aneurysms
  • Aortic Dissection
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2015
August 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
United States
IRB(2)0312-0064 ( Other Identifier: TMHRI IRB )
BS11-000639 ( Other Identifier: Other ID )
Not Provided
Plan to Share IPD: No
Plan Description: No plan to share available data.
The Methodist Hospital System
The Methodist Hospital System
Not Provided
Principal Investigator: Basel Ramlawi, MD The Methodist Hospital Department of Cardiovascular Surgery
The Methodist Hospital System
June 2016