An observational study in Surgical Bleeding, Aneurysms and Aortic Dissection, sponsored by Michael Reardon, MD. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2018-01-18.
Sponsored by Michael Reardon, MD · Observational
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].
960 studies on the registry are indexed under Aneurysm; 174 are open to participants now.
This study's enrollment of 150 is close to the median of 151 across 443 observational studies indexed under Aneurysm.
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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.
Exclusion Criteria:
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
Time frame: from day of surgery to 15-30 days after discharge
decrease length of stay
length of stay (LOS) in ICU, LOS in-hospital (admission to discharge); day of surgery to discharge
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Plan to share: No — No plan to share available data.
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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