Efficacy and safety of prolonged thromboprophylaxis with a low molecular weight heparin (dalteparin) after total hip arthroplasty--the Danish Prolonged Prophylaxis (DaPP) Study.
The aim of this study was to compare the efficacy and safety of prolonged (35 days) thromboprophylaxis with a standard length (7 days) regimen of a low molecular weight heparin in patients undergoing total hip arthroplasty. The study was multicentre, randomised, double-blind, and prospective with two groups. Following seven days on a standard length regimen of dalteparin (5000 antifactor Xa units subcutaneously once daily starting 12 h before surgery), patients were randomized to continue the prophylaxis with either subcutaneous injections of dalteparin or placebo injections for a further 28 days. Efficacy was evaluated at the end of the study (day 35) in all patients with bilateral ascending phlebography to detect deep vein thrombosis. Bleeding complications and other adverse events were registered throughout the study period. Three hundred consecutive patients agreed to participate before the operation: 281 were finally randomised and 215 completed the study; two patients died before randomisation; 17 developed deep vein thrombosis; none developed pulmonary embolism; and five of 113 patients (4.4%, 95% CI 1-10%) developed deep vein thrombosis in the dalteparin group, compared with 12 of 102 (11.8%; 95% CI 6-20%) in the placebo group (p=0.039). Deep vein thrombosis in the proximal veins was diagnosed in one patient (0.9%; 95% CI 0-5%) in the dalteparin group, and in five (5.0%; 95% CI 2-11%) in the placebo group (p=0.076). Major bleeding was observed in one patient in the placebo group; minor bleeding complications and adverse events were equally distributed between the groups. We concluded that prolonged (35 days) thrombo prophylaxis with dalteparin is more effective than a standard length (7 days) regimen without increased risk of bleeding complications or other adverse events.
Lassen
M R
MR
Aalborg Hospital, Denmark. mrlassen@tele6.post.dk
Borris
L C
LC
Anderson
B S
BS
Jensen
H P
HP
Skejø Bro
H P
HP
Andersen
G
G
Petersen
A O
AO
Siem
P
P
Hørlyck
E
E
Jensen
B V
BV
Thomsen
P B
PB
Hansen
B R
BR
Erin-Madsen
J
J
Møller
J C
JC
Rotwitt
L
L
Christensen
F
F
Nielsen
J B
JB
Jørgensen
P S
PS
Paaske
B
B
Tørholm
C
C
Hvidt
P
P
Jensen
N K
NK
Nielsen
A B
AB
Appelquist
E
E
Tjalve
E
E
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D019644:Arthroplasty, Replacement, Hip / Q000009:adverse effects*; D017985:Dalteparin / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D011183:Postoperative Complications / Q000517:prevention & control; D011446:Prospective Studies; D013927:Thrombosis / Q000209:etiology / Q000517:prevention & control*; D013997:Time Factors
D000925:Anticoagulants; D017985:Dalteparin