Point Of Care Coagulation For Standardized Monitoring And Dose Adjustment During A Clinical Trial Of A Low Molecular Weight Heparin

The study examined the use of a new low molecular weight heparin versus unfractionated heparin (UFH) among patients with ST-elevation myocardial infarction (STEMI) who had received fibrinolytic therapy and subsequently underwent percutaneous coronary intervention (PCI). This randomised, double-blind, double-dummy, parallel group, clinical study conducted in more than 20,000 patients in 48 countries required standardized coagulation monitoring so that the dosage could be adjusted during the procedure.

Unfractionated heparin (or matching placebo) was to be administered beginning with an intravenous bolus of 60 U per kilogram of body weight (maximum, 4000 U). The intravenous bolus was to be omitted for patients who received open-label unfractionated heparin (at least 4000 U) within three hours before randomization. Within 15 minutes after the intravenous bolus, an infusion of 12 U per kilogram per hour (initial maximum, 1000 U per hour) was begun. All monitoring of anticoagulation to adjust the dose of unfractionated heparin to maintain an activated partial-thromboplastin time of 1.5 to 2.0 times the control value was performed in a blinded fashion by personnel caring for the patient or in an unblinded fashion by a designated medical professional not involved in the patient's care. All aPTTs were measured locally with trial-supplied encrypted Hemochron Jr. Signature MicroCoagulation Point of Care Systems.

Published results reported that in patients receiving fibrinolysis for STEMI, treatment with LMWH throughout the index hospitalization is superior to treatment with UFH for 48 hours, but is associated with an increase in major bleeding episodes.