CoSeal for Hemostasis of Aortic Anastamoses

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by The Methodist Hospital System.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Basel Ramlawi, M.D., The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT01653769
First received: July 2, 2012
Last updated: July 27, 2012
Last verified: July 2012

July 2, 2012
July 27, 2012
June 2012
June 2013   (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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
length of stay (LOS) in ICU, LOS in-hospital (admission to discharge); day of surgery to discharge
Same as current
Not Provided
Not Provided
 
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
Observational Model: Cohort
Not Provided
Retention:   None Retained
Description:

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.
 
Recruiting
150
July 2013
June 2013   (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.
Both
Not Provided
No
Contact: Amanda Emmons, RN 713-441-3963 aemmons@tmhs.org
Contact: Raquel Bunge, RN 713-441-6509 rbunge@tmhs.org
United States
 
NCT01653769
BS11-000639
Yes
Basel Ramlawi, M.D., 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
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP