Prolonged thromboprophylaxis with Dalteparin during immobilization after ankle fracture surgery: a randomized placebo-controlled, double-blind study.
BACKGROUND
Skeletal trauma and immobilization are well-known risk factors for deep vein thrombosis (DVT) and pulmonary embolism (PE). While prophylaxis against thromboembolic complications has become routine after major orthopedic surgery, whether or not prophylaxis after minor surgery and lower limb immobilization is necessary is still under debate.


METHODS
In a double-blind, placebo-controlled study, 272 consecutive patients were randomized to receive either thromboprophylaxis with Dalteparin (n = 136) or placebo (n = 136) for 5 weeks after ankle fracture surgery. All patients received 1 week of initial treatment with Dalteparin before randomization. A unilateral phlebography was performed when the cast was removed.


RESULTS
The overall incidence of DVT was 21% (95% CI: 13-29%) in the Dalteparin group and 28% (CI: 19- 37%) in the placebo group (risk ratio = 0.8, CI: 0.6-1.1; p = 0.3). The incidence of proximal DVTs was 4% and 3%, respectively. No major bleeding occurred.


CONCLUSIONS
We found no significant difference in the incidence of DVT between the 2 treatment groups and our results do not support prolonged thromboprophylaxis. The overall incidence of DVT was high, reflecting the potential risk of PE and post-thrombotic syndrome after ankle fracture surgery. Most of the DVTs were asymptomatic, however, and were located in distal veins.
Lapidus
Lasse J
LJ
Department of Clinical Science and Education, Karolinska Institutet, Stockholm Söder Hospital, Stockholm, Sweden. lasse.lapidus@sodersjukhuset.se
Ponzer
Sari
S
Elvin
Anders
A
Levander
Catharina
C
Lärfars
Gerd
G
Rosfors
Stefan
S
de Bri
Edin
E
D000293:Adolescent; D000328:Adult; D000368:Aged; D016512:Ankle Injuries / Q000601:surgery*; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D002370:Casts, Surgical; D017985:Dalteparin / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D005592:Fracture Fixation / Q000009:adverse effects / Q000379:methods; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D009989:Orthotic Devices; D011183:Postoperative Complications / Q000175:diagnosis / Q000517:prevention & control; D011446:Prospective Studies; D012307:Risk Factors; D013997:Time Factors; D020246:Venous Thrombosis / Q000175:diagnosis / Q000517:prevention & control*
D000925:Anticoagulants; D005343:Fibrinolytic Agents; D017985:Dalteparin