Superficial Thrombophlebitis Clinical Trial
Official title:
Prospective, Randomized, Double-blinded Trial of the Efficacy and Safety of Different Doses and Duration of Low Molecular Weight Heparin (Dalteparin) in Superficial Vein Thrombosis
The aim of the study is to establish whether treatment of superficial vein thrombosis (SVT) with low-molecular-weight heparin in preventive or therapeutic doses prevents disease progression and thromboembolic events (deep vein thrombosis and pulmonary embolism), whether efficacy of low-molecular-weight heparin differs with regard to the dosage used (prevention, treatment), and to recognize groups of patients in which treatment with heparin is most efficient, as well as to determine factors that influence the efficacy of SVT treatment with heparin.
Until recently thrombophlebitis was regarded as a benign and self-limiting disease. Recent
studies have shown that various complications, especially vein thrombosis and pulmonary
thromboembolism, often accompany SVT. An observational study (Prospective Observational
Superficial Thrombophlebitis - POST) showed that three months after onset of the disease
thromboembolic events occurred in 10% of patients: pulmonary embolism in 0.4%, disease
progression in 3.1% and disease recurrence in 1.9% of patients. Therefore, SVT is now
frequently regarded as a part of the thromboembolic syndrome. On the basis of the evidence
referred to above anticoagulants, especially heparin, are used more and more often for
treatment of SVT instead of anti-inflammatory drugs and non-steroidal antirheumatics. Several
studies performed so far have examined the efficacy of standard and low-molecular-weight
heparin in various doses, but no final conclusion on the efficacy of treatment of SVT with
heparin has been established yet.
A study by Marchiori and colleagues showed that 8-12-day treatment of SVT with preventive and
therapeutic doses of low-molecular-weight heparin significantly reduces progression and
relapse of the disease, but not its thromboembolic complications. Another study demonstrated
that low-molecular-weight heparin in combination with elastic compression was not
significantly more effective than compression alone. Comparison of preventive and therapeutic
doses of low-molecular-weight heparin given to patients over the period of one month after
disease onset showed no differences in the efficacy in prevention of disease progression and
thromboembolic complications. The standard (unfractionated) heparin was also shown to be
effective in preventing disease progression, however, but not in preventing thromboembolic
complications. It is also not clear how long the treatment with heparin should last. So far
only one study compared the efficacy of treatment with various doses of low-molecular-weight
heparin from one month to three months' duration; it demonstrated that 1-month treatment with
lower doses of heparin was as effective as 3-month treatment with therapeutic doses of
heparin. A recent study (CALISTO) compared the efficacy of preventive doses of fondaparinux
(2.5 mg) with placebo in more than 3,000 patients with SVT and concluded that anticoagulant
treatment of SVT probably does not significantly influence prevention of thromboembolic
complications (Abstract presented at the 5th Annual Meeting of the American Society of
Hematology).
Results of recent studies show that heparin (standard or low-molecular-weight heparin) in
various doses prevents SVT progression, but no final agreement has emerged as to whether they
prevent the occurrence of thromboembolic complications. Interpretation of the results is
difficult because of the heterogeneity of the patients included in certain studies and
especially because of unavailability of subgroup analyses, which would help to establish
whether treatment with heparin is more effective in certain groups of patients with SVT than
in those with presenting forms of the disease. Latest (2008) guidelines for prevention of
venous thromboembolic events adopted by the American College of Chest Physicians (ACCP)
recommend treatment with at least preventive or median doses of low-molecular-weight heparin
or standard heparin for the duration of not less than 4 weeks. This recommendation was based
on a very low evidence level (level 2B).
In this study, we aim to investigate whether the extensiveness of thrombophlebitis and the
proximal distance of the end of a blood clot from saphenofemoral and saphenopopliteal
junction influence the efficacy of SVT treatment with heparin. The investigators shall also
monitor the expression of systemic inflammatory parameters that might be related to the
efficacy of the treatment and progression of the disease.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00264381 -
Management of Superficial Thrombophlebitis
|
Phase 4 |