253 outpatients were included in a prospective randomized study. All patients had incidences of injuries of the lower limb immobilized by a plaster cast. 126 patients (group I) received a subcutaneous injection of Fraxiparin daily, and 127 patients (group II) received no thromboprophylaxis. Without prophylaxis 21 (16.5%) cases developed a thrombosis, and with prophylaxis a thrombosis could be proven in 6 (4.8%) patients only (p < 0.01). Thus, for all patients with an injury of the lower limb being immobilized by a plaster cast, a thromboprophylaxis with a low-molecular-weight heparin is recommended.
The peri- and postsurgical thromboembolic prophylaxis with low molecular weight heparins is a well established therapy regimen, but the optimum duration of prophylaxis after surgery still remains uncertain. A few studies have pointed to the fact that the thromboembolic risk of high-risk patients persists longer than the in-hospital period correlating with respective hypercoagulatory conditions. The aim of the present study was to test if a prolongation of thromboprophylaxis with the low molecular weight heparin Certoparin further reduces the rate of thromboembolism in high-risk patients after orthopedic surgery. The "Long-term Thromboprophylaxis"-Study was a multicenter, randomized, double-blind, placebo-controlled trial. 360 patients who underwent endoprothetic joint replacement or osteosynthesis of the lower limb were initially enrolled, all of them received prophylactically 3000 U anti-Xa of Certoparin once daily for 14 days followed by randomization to prolonged Certoparin application or to placebo up to day 42. Patients were screened for deep vein thrombosis by sonography every week. Coagulation markers (fibrin monomers and D-dimers) were determined during the course of the study. Venous thromboembolism during the prolongation period was observed in 18 patients receiving placebo versus 8 patients of the prolonged Certoparin group (12.1% versus 5.0%, intention-to-treat sample). The analysis revealed a statistically significant difference in favor of Certoparin (p=0.020), which was confirmed by per-protocol analysis (14.2% versus 5.5%, p=0.012). The differences remained significant, if analyses considered only clinically symptomatic thromboembolic events (p=0.040). Patients who developed a thrombosis showed a strong increase of coagulation markers as compared to patients without subsequent thrombosis. The respective differentiation started around 18 days before diagnosis of thrombosis. Only one minor bleeding complication was observed during prolonged Certoparin prophylaxis. The present study shows that patients after joint replacement or osteosynthesis of the lower extremities have a persisting risk to develop thromboembolic complications beyond the routine duration of thromboprophylaxis. Extended prophylaxis with Certoparin resulted in a significantly lower rate of thromboembolism and should be strongly recommended.
The antithrombotic effect of a low molecular weight heparin was examined in a prospective randomized trial of 204 outpatients (121 men, 83 women, mean age 34.7 [16-76] years) who required immobilization with a plaster cast because of injury to the lower limb. Subjects in group I (n = 99) received a daily subcutaneous injection (36 mg) of heparin fragment calcium throughout their period in plaster (mean of 15.6 [7-66] days), while group II subjects (n = 105, mean period in plaster 15.7 [7-41] days) acted as untreated controls. Thrombosis was diagnosed by compression sonography, and positive findings were confirmed by phlebography. Thrombosis occurred in 24 patients altogether, 6 in group I (6.1%) and 18 in group II (17.1%) (P less than 0.05). While patients with thromboses had a mean of 1.96 risk factors overall, those in group I had a mean of 2.6 risk factors. Patients without thrombosis had a mean of 1.24 risk factors. The rate of thrombosis was higher in patients with fractures (4 out of 27 in group I; 10 out of 35 in group II) than in those with ligament and soft-tissue injuries (2 out of 72 in group I; 8 out of 70 in group II). The severity of trauma is apparently an important thrombogenic factor.--General thrombo-prophylaxis seems advisable for surgical outpatients requiring immobilisation treatment with a plaster cast.
In the last decade the performance of an adequate perioperative prophylaxis for venous thromboembolism (VTE) has become an established in-hospital measure. Although new antithrombotic drugs (oral thrombin inhibitors, fondaparinux) could reduce the incidence of perioperative VTE the absolute number remains high. In contrast to the widely accepted in-hospital perioperative prophylaxis, it is still unclear whether prophylaxis has to be prolonged after the hospital stay ("out-of-hospital prophylaxis"). In this review we will demonstrate by evaluation of recent studies and recommendations that a prolonged out-of-hospital prophylaxis for venous thromboembolism can further reduce the incidence of VTE after surgery, mainly orthopaedic surgery, e.g. endoprothetic joint replacement. At present low molecular weight heparins (LMWH) may be most effective and exhibit a low risk for major bleeding. Similar studies with other antithrombotics and other types of surgery are still missing. Finally the medico-legal aspects concerning postoperative in-hospital and extended prophylaxis are discussed.
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