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
  Purpose

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
Surgical Bleeding
Aneurysms
Aortic Dissection

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: CoSeal for Hemostasis of Aortic Anastomoses: A Propensity-Matched Cohort Study

Resource links provided by NLM:


Further study details as provided by The Methodist Hospital System:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   None Retained

Time perspective is both retrospective and prospective.


Estimated Enrollment: 150
Study Start Date: June 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
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].

  Eligibility

Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653769

Contacts
Contact: Amanda Emmons, RN 713-441-3963 aemmons@tmhs.org
Contact: Raquel Bunge, RN 713-441-6509 rbunge@tmhs.org

Locations
United States, Texas
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Emmons       aemmons@tmhs.org   
Principal Investigator: Basel Ramlawi, MD         
Sponsors and Collaborators
The Methodist Hospital System
Investigators
Principal Investigator: Basel Ramlawi, MD The Methodist Hospital Department of Cardiovascular Surgery
  More Information

No publications provided

Responsible Party: Basel Ramlawi, M.D., Attending Surgeon, Cardiac Surgery and Transplantation, The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT01653769     History of Changes
Other Study ID Numbers: BS11-000639
Study First Received: July 2, 2012
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Methodist Hospital System:
CoSeal
Surgical bleeding
hemostasis
Aortic anastamoses
bleeding
Cardiac surgery
Aneurysms
Aortic Dissection

Additional relevant MeSH terms:
Aneurysm
Cardiovascular Diseases
Vascular Diseases
Hemostatics
Coagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014