Chest
Clinical Investigations: Pulmonary EmbolismReduced Dose Bolus Alteplase vs Conventional Alteplase Infusion for Pulmonary Embolism Thrombolysis: An International Multicenter Randomized Trial
Section snippets
Methods
The protocol was approved by the human subjects committees of the 28 participating hospitals in the United States, Italy, and Canada, and by the FDA. Participating institutions were predesignated as angiography or echocardiography centers. Written informed consent was obtained from all patients. The trial ran between August 29, 1991, and December 14, 1992. Nineteen centers enrolled 48 patients in a coagulation laboratory ancillary study that began on February 10, 1992.
Patients 18 years of age
Results
The 90 patients who were enrolled, 61 to bolus rt-PA and 29 to 2-h rt-PA, had similar clinical baseline characteristics (Table 1). One patient randomized to bolus rt-PA at an echocardiogram center had an increasingly large pericardial effusion on echocardiogram, and the treating physicians decided not to proceed with thrombolytic therapy. Two patients at angiogram centers assigned to 2-h rt-PA had their randomization kits opened before completion of pulmonary angiography. The angiogram of one
Discussion
The principal hypothesis in our trial was that 0.6 mg/kg of bolus rt-PA (maximum of 50 mg) would be associated with fewer major and other important bleeding events than a fixed dose of 100 mg of 2-h rt-PA. However, we did not detect a significant difference between the two treatment groups with respect to bleeding complications. If a difference does exist in favor of bolus rt-PA, it is much smaller than we would have anticipated from previous bolus rt-PA studies5 and would have required
ACKNOWLEDGMENTS
The Bolus Alteplase Pulmonary Embolism (BAPE) Group is an international research group consisting of the following individuals, committees, and institutions represented as follows: Principal Investigator: Samuel Z. Goldhaber, MD, FCCP; National Coordinators: Samuel Z. Goldhaber, MD, FCCP, (United States), Giancarlo Agnelli, MD (Italy), Mark N. Levine, MD (Canada); Data Monitoring and Safety Committee: Eugene Braunwald, MD, FCCP, (Chairman) (Boston), Yiannis Bassiakos, PhD (Brookline), Michael
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Supported in part by grants from Genentech, Inc and Boehringer Ingelheim Italia.
Dr. Samuel Z. Goldhaber receives support from the National Heart, Lung, and Blood Institute Academic Award in Systemic and Pulmonary Vascular Medicine (HL 02663).
A list of the BAPE Group members appears in the Acknowledgment.
Revision accepted April 25.