Summary
Dermatan sulphate (MF 701) is a natural glycosaminoglycan that catalyses thrombin
inhibition by heparin cofactor II. The aim of the study was to evaluate the efficacy
and safety of MF 701 for prevention of deep vein thrombosis (DVT) in patients with
hip fracture. A randomised, double-blind, placebo-controlled design was used to assess
two dose regimens of MF 701 in two consecutive study phases. Treatment was started
within 48 h from the trauma and continued for 14 days for non-operated patients or
until the 10th postoperative day. Bilateral mandatory venography was used to assess
the end-point. Eighty patients were included in the first phase (40 MF 701, 40 placebo).
MF 701, 100 mg IM b. i. d., did not reduce incidence of DVT from that on placebo and
did not induce any bleeding. In the second phase 126 patients were included, with
a randomisation ratio of 2:1 (84 MF 701, 300 mg IM b.i.d., 42 placebo). Bilateral
venography was obtained for 110 patients. The incidence of DVT was 64% (23/36) in
the placebo group and 38% (28/74) in the MF 701 group (p = 0.01; odds ratio [OR] = 0.34, 95% confidence limits [CL] = 0.15-0.80); proximal
DVTs were 42% (15/36) and 20% (15/74), respectively (p = 0.02; OR = 0.36, CL = 0.15-0.89). No significant differences were found in haemorrhagic
complications (2.4% in each group), blood loss from drains, blood transfusions, haemoglobin
and haematocrit values. This study is the first demonstration that dermatan sulphate
is a clinically effective antithrombotic agent without bleeding effects. It also provides
evidence of the biological role of heparin cofactor II.
