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

    Zwischenberger, J. B., Tao, W., Deyo, D. J., Vertrees, R. A., Alpard, S. K., & Shulman, G. (2001). Safety and efficacy of a heparin removal device: A prospective randomized preclinical outcomes study. Annals of Thoracic Surgery, 71(1), 270-277. https://doi.org/10.1016/S0003-4975(00)01990-1

    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, JB, Tao, W, Deyo, DJ, Vertrees, RA, Alpard, SK & Shulman, G 2001, 'Safety and efficacy of a heparin removal device: A prospective randomized preclinical outcomes study', Annals of Thoracic Surgery, vol. 71, no. 1, pp. 270-277. https://doi.org/10.1016/S0003-4975(00)01990-1
    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.
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    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.",
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