CoSeal for Hemostasis of Aortic Anastamoses

NCT01653769 | Completed DMC

• 3 other identifiers: Pro00007251IRB(2)0312-0064BS11-000639
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Bleeding; Aneurysms; Aortic Dissection

Keywords

CoSeal; Surgical bleeding; hemostasis; Aortic anastamoses; bleeding; Cardiac surgery; Aneurysms; Aortic Dissection

Outcome Measures

Primary Outcomes (1)

• reduction in intra- and post-operative bleeding for procedures using CoSeal for hemostasis

  estimated blood loss/chest drain output; blood product requirement during surgery; re-operation for bleeding

  from day of surgery to 15-30 days after discharge

Secondary Outcomes (1)

• decrease length of stay

  participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• The study will include all patients undergoing cardio-thoracic surgery requiring a large aortic anastomosis.

You may not qualify if:

• Patients with severe preoperative coagulopathy, connective tissue disorders and disseminated intravascular coagulopathy (DIC) will be excluded.

Sponsors & Collaborators

• Michael Reardon, MD: lead
• The Methodist Hospital Research Institute: collaborator

Study Sites (1)

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: NONE RETAINED

Time perspective is both retrospective and prospective.

MeSH Terms

Conditions

Aneurysm; Aortic Dissection; Hemorrhage

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Aortic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Reardon, MD

  The Methodist Hospital Department of Cardiovascular Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator/Principal Investigator

Study Record Dates

• First Submitted: July 2, 2012
• First Posted: July 31, 2012
• Study Start: June 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 18, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)