Randomized controlled trial of tissue plasminogen activator in proximal deep venous thrombosis

Samuel Z. Goldhaber, Michael F. Meyerovitz, Eugene Braunwald, David Green, Robert L. Vogelzang, Paul Citrin, John Heit, Michael Sobel, H. Brownell Wheeler, Dennis Plante, Hugh Kim, Alan Hopkins, Margaret Tufte, David Stump

Research output: Contribution to journalArticlepeer-review

136 Scopus citations

Abstract

purpose: To compare the efficacy and safety of recombinant human tissue-type plasminogen activator (rt-PA, supplied as Activase®) with heparin alone or rt-PA plus heparin in the treatment of venographiacally documented proximal deep venous thrombosis (DVT) of the leg. patients and methods: Sixty-four patients underwent 65 randomizations to rt-PA alone (n = 36), rt-PA plus heparin (n = 17), or heparin alone (n = 12) in a prospective, multicenter, randomized, open-label trial, with efficacy assessed by a radiology panel unaware of treatment assignment. Patients randomly assigned to rt-PA received 0.05 mg/kg/hour for 24 hours via a peripheral vein, with a maximum dose of 150 mg. All patients then received heparin and warfarin for the remainder of the hospitalization. Follow-up venography was performed 24 to 36 hours after initiation of therapy. results: Complete or more than 50 % lysis occurred in 10 (28%) patients treated with rt-PA, five (29%) patients with rt-PA plus heparin, and no patient treated with heparin. No lysis occurred in 16 (44%) patients treated with rt-PA plus heparin, and 10 (83%) patients who received heparin alone (p = 0.04). There was one major complication, a nonfatal intracranial hemorrhage in a patient who received rt-PA alone. At 7 to 10 days after initiation of treatment, the level of serum glutamic oxaloacetic transaminase nearly doubled among all patients, including those assigned to received heparin alone. conclusion: (1) rt-PA and rt-PA plus heparin cause more clot lysis than heparin alone; (2) the addition of heparin to rt-PA does not improve the lysis rate; (3) DVT treated with heparin is commonly associated with a rise in the transaminase level; (4) heparin does not increase the risk of bleeding from rt-PA therapy; and (5) alternative dosing regimens and modes of administration of rt-PA should be investigated to improve further its efficacy and safety in the treatment of acute DVT.

Original languageEnglish (US)
Pages (from-to)235-240
Number of pages6
JournalThe American Journal of Medicine
Volume88
Issue number3
DOIs
StatePublished - Mar 1990

ASJC Scopus subject areas

  • Medicine(all)

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