Multicenter pilot study of the efficacy and safety of systemic rt-PA administration in the treatment of deep vein thrombosis of the lower extremities and/or pelvis.
Patients with symptoms of deep vein thrombosis for less than 10 days were treated with a standard dose of heparin. In the open label phase of the trial, 11 patients received 100 mg rt-PA on the first day and 50 mg on the subsequent day in an 8 hour infusion. In the double-blind phase, 8 patients were randomized to the same rt-PA regimen, 6 patients to an infusion of 50 mg rt-PA over 8 hours on days 1 and 2, and 7 patients to placebo infusions. The mean change in venographic score in all patients treated with rt-PA plus heparin is -3.8 units compared to -0.6 units in patients treated with heparin alone (p = 0.06). Bleeding complications classified as major were noted in 8/25 patients receiving the combined treatment.
Verhaeghe
R
R
University Hospital Gasthuisberg, Leuven, Belgium.
Besse
P
P
Bounameaux
H
H
Marbet
G A
GA
D000293:Adolescent; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006493:Heparin / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D010388:Pelvis; D010865:Pilot Projects; D011897:Random Allocation; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D013924:Thrombophlebitis / Q000188:drug therapy*; D010959:Tissue Plasminogen Activator / Q000009:adverse effects / Q000627:therapeutic use*
D011994:Recombinant Proteins; D006493:Heparin; D010959:Tissue Plasminogen Activator