Facilitating Hemostasis After Proximal Aortic Surgery: Results of The PROTECT Trial

PROTECT Investigators

Research output: Contribution to journalArticle

Abstract

Background: This study intended to evaluate the safety and hemostatic efficacy of a novel vascular sealant (Tridyne; Neomend, Inc, Irvine, CA) compared with an accepted adjunctive hemostatic agent applied to aortotomy and sutures lines in cardiovascular operations. Methods: Patients undergoing aortic valve replacement, ascending aortic replacement, or aortic root replacement were randomly assigned 2:1 to Tridyne (n = 107) or Gelfoam Plus (Baxter Healthcare Corp, Hayward, CA) (n = 51). These groups were similar with regard to age, sex, race, medical history, duration of bypass and cross-clamping, and number of suture lines treated. Suture lines were treated after confirmation of some leakage but before formal removal of the clamp. Results: The median bleeding time was significantly lower for Tridyne versus Gelfoam Plus (0 versus 10.0 minutes, p < 0.0001). Immediate hemostasis was achieved in 59.4% of the Tridyne group versus 16.0% of Gelfoam Plus group (p < 0.0001). A significantly greater proportion of patients in the Tridyne group achieved successful hemostasis at the aortic suture line than patients in the Gelfoam Plus group (85.7% versus 40.0%, p < 0.0001). The Clinical Events Committee adjudicated 7 patients with possible device-related serious adverse events: 3 patients (2.9%) in the Tridyne group and 4 patients (8.2%) in the Gelfoam Plus group (p = 0.2097). Conclusions: Tridyne was safe and effective when used as an adjunct to conventional hemostasis to treat high-pressure vessels in patients who receive anticoagulation agents, in reducing time to hemostasis, and in promoting both immediate and persistent hemostasis.

Original languageEnglish (US)
Pages (from-to)1357-1364
Number of pages8
JournalAnnals of Thoracic Surgery
Volume105
Issue number5
DOIs
StatePublished - May 1 2018

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Hemostasis
Absorbable Gelatin Sponge
Sutures
Hemostatics
Bleeding Time
Aortic Valve
Constriction
Anticoagulants
Blood Vessels
Delivery of Health Care
Safety
Pressure
Equipment and Supplies

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine

Cite this

@article{9aa0a862ad704d3791f679960cb692d0,
title = "Facilitating Hemostasis After Proximal Aortic Surgery: Results of The PROTECT Trial",
abstract = "Background: This study intended to evaluate the safety and hemostatic efficacy of a novel vascular sealant (Tridyne; Neomend, Inc, Irvine, CA) compared with an accepted adjunctive hemostatic agent applied to aortotomy and sutures lines in cardiovascular operations. Methods: Patients undergoing aortic valve replacement, ascending aortic replacement, or aortic root replacement were randomly assigned 2:1 to Tridyne (n = 107) or Gelfoam Plus (Baxter Healthcare Corp, Hayward, CA) (n = 51). These groups were similar with regard to age, sex, race, medical history, duration of bypass and cross-clamping, and number of suture lines treated. Suture lines were treated after confirmation of some leakage but before formal removal of the clamp. Results: The median bleeding time was significantly lower for Tridyne versus Gelfoam Plus (0 versus 10.0 minutes, p < 0.0001). Immediate hemostasis was achieved in 59.4{\%} of the Tridyne group versus 16.0{\%} of Gelfoam Plus group (p < 0.0001). A significantly greater proportion of patients in the Tridyne group achieved successful hemostasis at the aortic suture line than patients in the Gelfoam Plus group (85.7{\%} versus 40.0{\%}, p < 0.0001). The Clinical Events Committee adjudicated 7 patients with possible device-related serious adverse events: 3 patients (2.9{\%}) in the Tridyne group and 4 patients (8.2{\%}) in the Gelfoam Plus group (p = 0.2097). Conclusions: Tridyne was safe and effective when used as an adjunct to conventional hemostasis to treat high-pressure vessels in patients who receive anticoagulation agents, in reducing time to hemostasis, and in promoting both immediate and persistent hemostasis.",
author = "{PROTECT Investigators} and Ali Khoynezhad and Jacob DelaRosa and Moon, {Marc R.} and Brinkman, {William T.} and Thompson, {Richard B.} and Desai, {Nimesh D.} and Malaisrie, {S Chris} and Girardi, {Leonard N.} and Bavaria, {Joseph E.} and Reece, {T. Brett}",
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doi = "10.1016/j.athoracsur.2017.12.013",
language = "English (US)",
volume = "105",
pages = "1357--1364",
journal = "Annals of Thoracic Surgery",
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}

Facilitating Hemostasis After Proximal Aortic Surgery : Results of The PROTECT Trial. / PROTECT Investigators.

In: Annals of Thoracic Surgery, Vol. 105, No. 5, 01.05.2018, p. 1357-1364.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Facilitating Hemostasis After Proximal Aortic Surgery

T2 - Results of The PROTECT Trial

AU - PROTECT Investigators

AU - Khoynezhad, Ali

AU - DelaRosa, Jacob

AU - Moon, Marc R.

AU - Brinkman, William T.

AU - Thompson, Richard B.

AU - Desai, Nimesh D.

AU - Malaisrie, S Chris

AU - Girardi, Leonard N.

AU - Bavaria, Joseph E.

AU - Reece, T. Brett

PY - 2018/5/1

Y1 - 2018/5/1

N2 - Background: This study intended to evaluate the safety and hemostatic efficacy of a novel vascular sealant (Tridyne; Neomend, Inc, Irvine, CA) compared with an accepted adjunctive hemostatic agent applied to aortotomy and sutures lines in cardiovascular operations. Methods: Patients undergoing aortic valve replacement, ascending aortic replacement, or aortic root replacement were randomly assigned 2:1 to Tridyne (n = 107) or Gelfoam Plus (Baxter Healthcare Corp, Hayward, CA) (n = 51). These groups were similar with regard to age, sex, race, medical history, duration of bypass and cross-clamping, and number of suture lines treated. Suture lines were treated after confirmation of some leakage but before formal removal of the clamp. Results: The median bleeding time was significantly lower for Tridyne versus Gelfoam Plus (0 versus 10.0 minutes, p < 0.0001). Immediate hemostasis was achieved in 59.4% of the Tridyne group versus 16.0% of Gelfoam Plus group (p < 0.0001). A significantly greater proportion of patients in the Tridyne group achieved successful hemostasis at the aortic suture line than patients in the Gelfoam Plus group (85.7% versus 40.0%, p < 0.0001). The Clinical Events Committee adjudicated 7 patients with possible device-related serious adverse events: 3 patients (2.9%) in the Tridyne group and 4 patients (8.2%) in the Gelfoam Plus group (p = 0.2097). Conclusions: Tridyne was safe and effective when used as an adjunct to conventional hemostasis to treat high-pressure vessels in patients who receive anticoagulation agents, in reducing time to hemostasis, and in promoting both immediate and persistent hemostasis.

AB - Background: This study intended to evaluate the safety and hemostatic efficacy of a novel vascular sealant (Tridyne; Neomend, Inc, Irvine, CA) compared with an accepted adjunctive hemostatic agent applied to aortotomy and sutures lines in cardiovascular operations. Methods: Patients undergoing aortic valve replacement, ascending aortic replacement, or aortic root replacement were randomly assigned 2:1 to Tridyne (n = 107) or Gelfoam Plus (Baxter Healthcare Corp, Hayward, CA) (n = 51). These groups were similar with regard to age, sex, race, medical history, duration of bypass and cross-clamping, and number of suture lines treated. Suture lines were treated after confirmation of some leakage but before formal removal of the clamp. Results: The median bleeding time was significantly lower for Tridyne versus Gelfoam Plus (0 versus 10.0 minutes, p < 0.0001). Immediate hemostasis was achieved in 59.4% of the Tridyne group versus 16.0% of Gelfoam Plus group (p < 0.0001). A significantly greater proportion of patients in the Tridyne group achieved successful hemostasis at the aortic suture line than patients in the Gelfoam Plus group (85.7% versus 40.0%, p < 0.0001). The Clinical Events Committee adjudicated 7 patients with possible device-related serious adverse events: 3 patients (2.9%) in the Tridyne group and 4 patients (8.2%) in the Gelfoam Plus group (p = 0.2097). Conclusions: Tridyne was safe and effective when used as an adjunct to conventional hemostasis to treat high-pressure vessels in patients who receive anticoagulation agents, in reducing time to hemostasis, and in promoting both immediate and persistent hemostasis.

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