Swedish - Norwegian multicenter trial: A randomized double blind study on the prevention of postoperative deep vein thrombosis (DVT) - heparin fragment (fragmin) from the evening before surgery vs conventional low-dose heparin

1987 ◽  
Vol 45 ◽  
pp. 20 ◽  
Author(s):  
D Berqqvist ◽  
J Frisell ◽  
T Hallböök ◽  
A Horn ◽  
A Lindhagen ◽  
...  
1987 ◽  
Author(s):  
D Bergqvist ◽  
J Frisel ◽  
T Hallböök ◽  
A Horn ◽  
A Lindhagen ◽  
...  

Bergen, Halmstad, Goteborg and KabiVitrum AB Stockholm, Sweden and Norway. At the Xth Int. Congress on Thrombosis and Haemostasis in San Diego results from a multicenter trial on 432 patients were presented, comparing a low molecular weight heparin (LMWH) fragment (Fragmin, Kabi) once daily with low dose heparin twice daily. Prophylaxis started 2 hours preoperatively. The frequency of postoperative DVT did notdiffer (6.4 % v. 4.3 %) but the onset of thrombosis was delayed in the LMWH group. Haemorrhagic complications occurred significantly more often in the LMWH group (11.6 % v. 4.6 ?o). The results were similar independent whether the analysis was made according to the intention to treat principle or based on patients with correct prophylaxis. On the basis of these data and newer knowledge regarding the pharmacokinetics of LMWH a second prospective randomized double-blind multicenter trial on patients.older than 40 years undergoing elective abdominal surgery was started. The only difference was that the first dose of 5000 ariti-factor Xa units of LMWH was given on the evening before surgery. Only conventional low dose heparin was given 2 h before surgery. The study is designed to include 1000patients, a number which will be obtained during the spring 1987. At the time of abstract deadline 799 patients have been included. The over-all frequency of DVT (fibrinogen uptake test) is 6.8 %, the frequency of haemorrhagic complications 3.6 % and mortality 1.8 % (one fatal pulmonary embolism). These frequencies remained unaltered after inclusion of 336, 576, 655 and 799 patients. Although the code has not been broken yet, it can be concluded that the new regimen with start of prophylaxis the evening before surgery has not altered the frequency of DVT or mortality whereas the frequency of haemorrhagic side effects has decreased considerably.


1976 ◽  
Vol 36 (01) ◽  
pp. 157-164 ◽  
Author(s):  
P. M Mannucci ◽  
Luisa E. Citterio ◽  
N Panajotopoulos

SummaryThe effect of subcutaneous low-dose heparin on postoperative deep-vein thrombosis (D. V. T.) (diagnosed by the 125I-labelled fibrinogen test) has been investigated in a trial of 143 patients undergoing the operation of total hip replacement. Two randomized studies were carried out: in one the scanning for D.V.T. was carried out daily for 7 days post operatively and in the other for 15 days. In both, the incidence of D.V.T. was significantly lower in the heparin-treated patients (P<0.005). Bilateral D.V.T. was also prevented (P<0.05), through the extension of D.V.T. to the distal veins of the thigh was not significantly reduced. Heparin treatment was, however, followed by a higher incidence of severe postoperative bleeding (P< 0.02) and wound haematoma formation (P< 0.005), and the postoperative haemoglobin was significantly lower than in the control group (P<0.005). A higher number of transfused blood units was also needed by the heparin treated patients (P<0.001).


1987 ◽  

The efficacy and safety of a low molecular weight heparin (Kabi 2165) in preventing postoperative deep vein thrombosis (D.V.T.), was assessed in a double blind randomly allocated multicenter trial. 385 patients were included and analysed on a intention to treat basis. Kabi 2165 was given S.C. 24 hourly in 2 500 anti-factor Xa units and compared with standard low dose calcium heparin 5 000 i.u. S.C. 12 hourly in patients undergoing major abdominal or gynaecological surgery. The first dose was administered two hours before operation in both groups. The relevant characteristics of the patients in the two treatment groups were similar. The two groups were well matched for risk factors which could predispose to D.V.T.DVT was detected by the radioactive fibrinogen test. Venography was performed whenever a positive scan developed in a patient. Six (3,1 96) of 195 patients receiving Kabi 2165 and seven (3,7 96) of 190 patients in the standard heparin group developed D.V.T. No pulmonary embolism we re detected during the prophylactic regimens. There was no significant difference between the two groups in terms of blood loss during surgery, postoperative drainage, blood transfusion, wound haematoma. Mean hemoglobin levels and mean hematocrit values preoperatively and postoperatively (day 1 and 6) were :There were no statistically significant differences in both groups. No thrombocytopenia was reported in this study. The antifactor Xa activity was significantly higher in the Kabi 2165 group.In conclusion, Kabi 2165 once daily is as effective and safe as standard heparin twice daily in preventing postoperative D.V.T. in general surgery.


1974 ◽  
Vol 44 (3) ◽  
pp. 289-291 ◽  
Author(s):  
J. Propsting ◽  
O. Williams ◽  
M. Stathis ◽  
J. F. Mccaffrey

The Lancet ◽  
1978 ◽  
Vol 311 (8056) ◽  
pp. 160-161
Author(s):  
O.J.S. Buruma ◽  
A.R. Wintzen ◽  
E. Briët

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