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Abstract
A prospective, randomized, assessor-blind trial has been undertaken to compare the
thromboprophylactic effect and safety of the heparinoid Org 10172 (a mixture of low
molecular-weight sulfated glycosaminoglycuronides) and dextran 70 in patients operated
on for hip fracture. Prestudy biostatistical calculations led to the need for 260
patients. Three hundred eight patients were randomized and 19 were excluded after
randomization, the majority because of postponed surgery. Analyses were made on the
289 patients on an intention-to-treat basis, as well as on the 247 patients given
correct prophylaxis. Diagnosis of deep vein thrombosis was based on bilateral ascending
phlebography on postoperative days 10 through 12. The frequency of deep vein thrombosis
on an intention-to-treat basis was 10% in the Org 10172 group and 30% in the dextran
70 group and, on the basis of correct prophylaxis, 12% and 31%, respectively, both
differences being significant (p < 0.001). Two-month mortality rates were equal in
the groups. Three fatal pulmonary emboli were seen in the dextran group. Significantly
more patients in the dextran group received postoperative transfusions; no other differences
in various hemorrhagic parameters were seen. Thus it can be concluded that Org 10172
has a significantly better thromboprophylactic effect than does dextran in patients
with hip fractures without significant side effects.
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Article info
Publication history
Accepted:
August 21,
1990
Footnotes
☆Supported by Swedish Medical Research Council grant 00759.
☆☆Presented at the Second Annual American Venous Forum Meeting, Coronado, Calif., Feb. 21–23, 1990.
Identification
Copyright
© 1991 Published by Elsevier Inc.
