A Dose-Determining Trial of Heparinase-I (Neutralase™) for Heparin Neutralization in Coronary Artery Surgery
| Autor: | Barbara E. Tardiff, Jay Horrow, Glenn P. Gravlee, Thomas Barragry, John Luber, Joel Schneider, Richard Broughton, Edward K. Heres |
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| Rok vydání: | 2001 |
| Předmět: |
Adult
Male Coronary artery surgery Whole Blood Coagulation Time medicine.drug_class Blood Pressure law.invention law medicine Cardiopulmonary bypass Humans Protamines Cardiac Output Coronary Artery Bypass Blood Coagulation Aged Heparinase biology Heparin business.industry Anticoagulant Anticoagulants Heparin Antagonists Middle Aged Protamine Heparin lyase Anesthesiology and Pain Medicine Heparin Lyase Chest Tubes Anesthesia biology.protein Female business Heparin neutralization medicine.drug |
| Zdroj: | Anesthesia & Analgesia. 93:1446-1452 |
| ISSN: | 0003-2999 |
| Popis: | Heparinase-I, a specific heparin-degrading enzyme, may represent an alternative to protamine. We explored the dose of heparinase-I for efficacy and safety in patients undergoing coronary artery surgery. At the conclusion of cardiopulmonary bypass, subjects received 5, 7, or 10 microg/kg of open-label heparinase-I instead of protamine. Activated clotting time (ACT) and its difference from a contemporaneous heparin-free sample (DeltaACT) at 3 min before and 3, 6, and 9 min after heparinase-I determined reversal efficacy. After surgery, we recorded hourly chest tube drainage. Systemic and pulmonary arterial blood pressure and cardiac output measurements before and immediately after heparinase-I were used to evaluate hemodynamic safety. Coagulation measurements included anti-factor Xa and anti-factor IIa activities. Forty-nine patients from seven institutions participated: 12 received 5 microg/kg, 21 received 7 microg/kg, 4 received two doses of 7 microg/kg, 8 received 10 microg/kg, and 4 received two doses of 10 microg/kg. Treatment groups did not differ demographically. Median DeltaACT 9 min later was 11, 7, and 4 s for the 5, 7, and 10 microg/kg groups, respectively. No adverse hemodynamic changes occurred with heparinase-I administration. The authors conclude that heparinase-I effectively restored the ACT after cardiopulmonary bypass. This effect appeared to be dose dependent.Heparinase-I (Neutralase(TM)) successfully restored activated coagulation time with no adverse hemodynamic events in patients undergoing coronary artery surgery with cardiopulmonary bypass in an open-label dose-determining trial. |
| Databáze: | OpenAIRE |
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