Prospective Clinical Trial of the Hemopatch Topic Hemostatic in Cardiac Surgery
A new topical hemostatic agent composed of a specifically-formulated porous collagen matrix, coated on one side with a thin protein bonding layer (known as NHS-PEG) has been reported to be extremely effective, in addition to traditional means, in terminating bleeding during cardiac operations with control rates as high as 97,5%. The investigators compared such hemostatic agent (Hemopatch; Baxter Inc, Deerfield, IL) with traditional optimized hemostasis routine.
Following sample size calculation, in a prospective randomized study design, 100 patients will be treated with Hemopatch and 100 patients will receive traditional optimized hemostasis routine (comparison group).
To make the two cohorts as comparable as possible enrollment will be restricted to moderately bleeding vascular anastomosis of Dacron grafts to ascending aorta or moderately bleeding transversal aortotomy.
Study endpoints are the following: rate of successful intraoperative hemostasis (identified by cessation of bleeding in less than 3 minutes from application) and time required for hemostasis; overall postoperative bleeding; rate of transfusion of blood products; rate of surgical revision for bleeding; postoperative morbidity; and intensive care unit stay.
|Bleeding||Device: Hemopatch Behavioral: Traditional Hemostasis Techniques (dry or wet gauze compression or similar)|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Prospective, Randomized Clinical Trial of the Hemopatch Topic Hemostatic in Cardiac Surgery.|
- Percentage of Successful Hemostasis in under 3 minutes [ Time Frame: 3 minutes ]Application of Hemopatch or traditional techniques (compression with dry or wet gauze or similar) are considered successful if hemostasis is reached in under 3 minutes
- Post Operative Blood Loss [ Time Frame: 6 hours ]Blood loss in the first 7 hours postoperatively
- Allogeneic Blood Transfusion [ Time Frame: 4 days ]Allogeneic Blood Transfusion in the first 4 days after surgery
|Study Start Date:||March 2014|
|Study Completion Date:||March 2015|
|Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Use of Hemopatch on bleeding spot
Sham Comparator: Control
Traditional techniques hemostasis (dry or wet gauze compression or similar)
|Behavioral: Traditional Hemostasis Techniques (dry or wet gauze compression or similar)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02133378
|Rome, Italy, 00151|