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A Journal on Phlebology
Acta Phlebologica 2000 December;1(2):63-7
Safety and feasibility of an individually tailored prophylaxis against venous thromboembolism in a Rehabilitation Unit
Arpaia G. 1, Vigoreli P. 1, Gussoni C. 1, D'Agostino B. 1, Cimminiello C. 2
1 Rehabilitation Unit, San Carlo Borromeo General Hospital, Milan;
2 2nd Medical Department, Vimercate General Hospital, Milan, Italy
BACKGROUND: Non-surgical patients—“medical” cases—often suffer venous thromboembolism (VTE) and a fair proportion require prophylaxis. However, there are no solid figures on the frequency of VTE in medical patients undergoing rehabilitation programs, or on the efficacy and safety of prophylactic regimens, which have obviously to be long-term in these patients. To assess prospectively the efficacy and safety, as regards bleeding, of prophylactic regimens adapted to take account of each patient's risk, in a population admitted to a Rehabilitation Unit after a “medical” disease.
METHODS: Ninety-five consecutive patients (50 women and 45 men, mean age 76.2±12 years), following a rehabilitation program after a medical disease, were stratified in relation to the risk of VTE using the 1992 TFR Consensus Group criteria, modified. Patients able to walk were not given prophylaxis; those at medium risk were given low-molecular weight (LMW) heparin, enoxaparin 2000 anti-Xa units/day s.c., and wore elastic support hose; high-risk patients received 4000 anti-Xa units/day of enoxaparin. Patients at high risk also of hemorrhagic complications used support stockings only. Patients were ineligible for the study if a Doppler ultrasound examination of the leg veins, with compression, had shown deep venous thrombosis (DVT) at admission. Patients scheduled for treatment received it throughout their hospital stay. The study endpoints were symptoms of VTE and any hemorrhagic complications.
RESULTS: The risk assessment was done for all the study patients so that 19 of them were considered at medium thrombotic risk and 76 at high risk. Of the whole initial cohort 20 subjects were walking and received no treatment. Sixteen patients resulted affected by DVT at the entry Doppler-ultrasound screening and were treated with therapeutic anticoagulation. The remaining 59 subjects were given a prophylactic regimen: 12 at medium risk with 2000 U/day enoxaparin plus support stockings; of the high risk population, 33 patients received 4000 U/day enoxaparin and 14 were given only support hose since they had contraindications to heparin. There were four major bleeds, one in a patient treated for DVT at admission, and three during high-dose enoxaparin prophylaxis. There was only one definite symptomatic episode of VTE during rehabilitation and three patients died: two suddenly, with a clinical suspicion of fatal pulmonary embolism, although this was not confirmed by autopsy, and one because of gradual deterioration of general conditions: this latter patient also showed the only case of symptomatic bilateral DVT.
CONCLUSIONS: Prophylaxis of VTE can be "personally-tailored" in relation to individual risk in patients following a rehabilitation program after a medical disease. This prevention must obviously be long-term, and is certainly safe; however, randomized controlled trials are needed to confirm its efficacy.