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CoSeal for Hemostasis of Aortic Anastamoses

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. Identifier: NCT01653769
Recruitment Status : Completed
First Posted : July 31, 2012
Last Update Posted : January 18, 2018
The Methodist Hospital System
Information provided by (Responsible Party):
Michael Reardon, MD, The Methodist Hospital System

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.

Condition or disease
Surgical Bleeding Aneurysms Aortic Dissection

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].

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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
Time perspective is both retrospective and prospective.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01653769

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United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Michael Reardon, MD
The Methodist Hospital System
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Principal Investigator: Michael Reardon, MD The Methodist Hospital Department of Cardiovascular Surgery
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Responsible Party: Michael Reardon, MD, Sponsor-Investigator/Principal Investigator, The Methodist Hospital System Identifier: NCT01653769    
Other Study ID Numbers: Pro00007251
IRB(2)0312-0064 ( Other Identifier: TMHRI IRB )
BS11-000639 ( Other Identifier: Other ID )
First Posted: July 31, 2012    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share available data.
Keywords provided by Michael Reardon, MD, The Methodist Hospital System:
Surgical bleeding
Aortic anastamoses
Cardiac surgery
Aortic Dissection
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases