Safety and efficacy of a heparin removal device: A prospective randomized preclinical outcomes study

Joseph B. Zwischenberger, Weike Tao, Donald J. Deyo, Roger A. Vertrees, Scott K. Alpard, Gerald Shulman

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Background. Systemic protamine sulfate for heparin reversal after cardiopulmonary bypass (CPB) is associated with uncommon, but life-threatening adverse reactions. Methods. In a prospective randomized 3-day outcomes study, a heparin removal device (HRD) group (n = 12; 60-, 80-, 100-kg subgroups) was compared with a matched systemic Protamine group (Protamine; n = 6) for safety and efficacy using an adult swine model of CPB (60 minutes, 28°C). Results. HRD run time was 25 to 38 minutes depending on weight without complications. After HRD, heparin concentration decreased from 4.77 ± 0.17 to 0.45 ± 0.06 U/mL (activated clotting time [ACT] 776 ± 83 to 180 ± 12 seconds), and in Protamine, 3.94 ± 0.63 to 0.13 ± 0.02 U/mL (ACT 694 ± 132 to 101 ± 5 seconds) (p = 0.01 between groups, but no significant differences 60 minutes later). No significant difference between HRD and Protamine to 72 hours was seen in plasma-free hemoglobin C3a, heparin concentration, thromboelastogram index, platelet count, activated partial thromboplastin time, anti-thrombin III, fibrinogen, ACT, and tissue histology. Conclusions. In a prospective randomized outcomes study, HRD achieved predictable, reversal of systemic heparinization after CPB with no difference in safety or outcomes compared with protamine.

Original languageEnglish (US)
Pages (from-to)270-277
Number of pages8
JournalAnnals of Thoracic Surgery
Volume71
Issue number1
DOIs
StatePublished - 2001

Fingerprint

Device Removal
Protamines
Heparin
Outcome Assessment (Health Care)
Safety
Cardiopulmonary Bypass
Partial Thromboplastin Time
Platelet Count
Thrombin
Fibrinogen
Histology
Hemoglobins
Swine
Weights and Measures

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Surgery

Cite this

Safety and efficacy of a heparin removal device : A prospective randomized preclinical outcomes study. / Zwischenberger, Joseph B.; Tao, Weike; Deyo, Donald J.; Vertrees, Roger A.; Alpard, Scott K.; Shulman, Gerald.

In: Annals of Thoracic Surgery, Vol. 71, No. 1, 2001, p. 270-277.

Research output: Contribution to journalArticle

Zwischenberger, Joseph B. ; Tao, Weike ; Deyo, Donald J. ; Vertrees, Roger A. ; Alpard, Scott K. ; Shulman, Gerald. / Safety and efficacy of a heparin removal device : A prospective randomized preclinical outcomes study. In: Annals of Thoracic Surgery. 2001 ; Vol. 71, No. 1. pp. 270-277.
@article{a3e4f4d169b24a10b39aa68098e0980e,
title = "Safety and efficacy of a heparin removal device: A prospective randomized preclinical outcomes study",
abstract = "Background. Systemic protamine sulfate for heparin reversal after cardiopulmonary bypass (CPB) is associated with uncommon, but life-threatening adverse reactions. Methods. In a prospective randomized 3-day outcomes study, a heparin removal device (HRD) group (n = 12; 60-, 80-, 100-kg subgroups) was compared with a matched systemic Protamine group (Protamine; n = 6) for safety and efficacy using an adult swine model of CPB (60 minutes, 28°C). Results. HRD run time was 25 to 38 minutes depending on weight without complications. After HRD, heparin concentration decreased from 4.77 ± 0.17 to 0.45 ± 0.06 U/mL (activated clotting time [ACT] 776 ± 83 to 180 ± 12 seconds), and in Protamine, 3.94 ± 0.63 to 0.13 ± 0.02 U/mL (ACT 694 ± 132 to 101 ± 5 seconds) (p = 0.01 between groups, but no significant differences 60 minutes later). No significant difference between HRD and Protamine to 72 hours was seen in plasma-free hemoglobin C3a, heparin concentration, thromboelastogram index, platelet count, activated partial thromboplastin time, anti-thrombin III, fibrinogen, ACT, and tissue histology. Conclusions. In a prospective randomized outcomes study, HRD achieved predictable, reversal of systemic heparinization after CPB with no difference in safety or outcomes compared with protamine.",
author = "Zwischenberger, {Joseph B.} and Weike Tao and Deyo, {Donald J.} and Vertrees, {Roger A.} and Alpard, {Scott K.} and Gerald Shulman",
year = "2001",
doi = "10.1016/S0003-4975(00)01990-1",
language = "English (US)",
volume = "71",
pages = "270--277",
journal = "Annals of Thoracic Surgery",
issn = "0003-4975",
publisher = "Elsevier USA",
number = "1",

}

TY - JOUR

T1 - Safety and efficacy of a heparin removal device

T2 - A prospective randomized preclinical outcomes study

AU - Zwischenberger, Joseph B.

AU - Tao, Weike

AU - Deyo, Donald J.

AU - Vertrees, Roger A.

AU - Alpard, Scott K.

AU - Shulman, Gerald

PY - 2001

Y1 - 2001

N2 - Background. Systemic protamine sulfate for heparin reversal after cardiopulmonary bypass (CPB) is associated with uncommon, but life-threatening adverse reactions. Methods. In a prospective randomized 3-day outcomes study, a heparin removal device (HRD) group (n = 12; 60-, 80-, 100-kg subgroups) was compared with a matched systemic Protamine group (Protamine; n = 6) for safety and efficacy using an adult swine model of CPB (60 minutes, 28°C). Results. HRD run time was 25 to 38 minutes depending on weight without complications. After HRD, heparin concentration decreased from 4.77 ± 0.17 to 0.45 ± 0.06 U/mL (activated clotting time [ACT] 776 ± 83 to 180 ± 12 seconds), and in Protamine, 3.94 ± 0.63 to 0.13 ± 0.02 U/mL (ACT 694 ± 132 to 101 ± 5 seconds) (p = 0.01 between groups, but no significant differences 60 minutes later). No significant difference between HRD and Protamine to 72 hours was seen in plasma-free hemoglobin C3a, heparin concentration, thromboelastogram index, platelet count, activated partial thromboplastin time, anti-thrombin III, fibrinogen, ACT, and tissue histology. Conclusions. In a prospective randomized outcomes study, HRD achieved predictable, reversal of systemic heparinization after CPB with no difference in safety or outcomes compared with protamine.

AB - Background. Systemic protamine sulfate for heparin reversal after cardiopulmonary bypass (CPB) is associated with uncommon, but life-threatening adverse reactions. Methods. In a prospective randomized 3-day outcomes study, a heparin removal device (HRD) group (n = 12; 60-, 80-, 100-kg subgroups) was compared with a matched systemic Protamine group (Protamine; n = 6) for safety and efficacy using an adult swine model of CPB (60 minutes, 28°C). Results. HRD run time was 25 to 38 minutes depending on weight without complications. After HRD, heparin concentration decreased from 4.77 ± 0.17 to 0.45 ± 0.06 U/mL (activated clotting time [ACT] 776 ± 83 to 180 ± 12 seconds), and in Protamine, 3.94 ± 0.63 to 0.13 ± 0.02 U/mL (ACT 694 ± 132 to 101 ± 5 seconds) (p = 0.01 between groups, but no significant differences 60 minutes later). No significant difference between HRD and Protamine to 72 hours was seen in plasma-free hemoglobin C3a, heparin concentration, thromboelastogram index, platelet count, activated partial thromboplastin time, anti-thrombin III, fibrinogen, ACT, and tissue histology. Conclusions. In a prospective randomized outcomes study, HRD achieved predictable, reversal of systemic heparinization after CPB with no difference in safety or outcomes compared with protamine.

UR - http://www.scopus.com/inward/record.url?scp=0035136342&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0035136342&partnerID=8YFLogxK

U2 - 10.1016/S0003-4975(00)01990-1

DO - 10.1016/S0003-4975(00)01990-1

M3 - Article

C2 - 11216760

AN - SCOPUS:0035136342

VL - 71

SP - 270

EP - 277

JO - Annals of Thoracic Surgery

JF - Annals of Thoracic Surgery

SN - 0003-4975

IS - 1

ER -