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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemopatch | Experimental | Use of Hemopatch on bleeding spot |
|
| Control | Sham Comparator | Traditional techniques hemostasis (dry or wet gauze compression or similar) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemopatch | Device | Baxter Hemopatch |
| |
| Traditional Hemostasis Techniques (dry or wet gauze compression or similar) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Successful Hemostasis in under 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 | 3 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Blood Loss | Blood loss in the first 7 hours postoperatively | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Allogeneic Blood Transfusion | Allogeneic Blood Transfusion in the first 4 days after surgery | 4 days |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Hospital | Rome | 00151 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19853105 | Background | Nasso G, Piancone F, Bonifazi R, Romano V, Visicchio G, De Filippo CM, Impiombato B, Fiore F, Bartolomucci F, Alessandrini F, Speziale G. Prospective, randomized clinical trial of the FloSeal matrix sealant in cardiac surgery. Ann Thorac Surg. 2009 Nov;88(5):1520-6. doi: 10.1016/j.athoracsur.2009.07.014. |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003890 | Desiccation |
| ID | Term |
|---|---|
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D055598 | Chemical Phenomena |
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| Behavioral |
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