Prolonged thromboprophylaxis with Dalteparin during immobilization after ankle fracture surgery: a randomized placebo-controlled, double-blind study.

Publisher: Medical Journals Sweden AB Country of Publication: Sweden NLM ID: 101231512 Publication Model: Print Cited Medium: Print ISSN: 1745-3674 (Print) Linking ISSN: 17453674 NLM ISO Abbreviation: Acta Orthop Subsets: MEDLINE

Publication: 2022- : Uppsala, Sweden : Medical Journals Sweden AB
Original Publication: Basingstoke, Hampshire, UK : Taylor & Francis, c2005-

Ankle Injuries/*surgery ; Anticoagulants/*administration & dosage ; Dalteparin/*administration & dosage ; Fibrinolytic Agents/*administration & dosage ; Venous Thrombosis/*prevention & control; Adolescent ; Adult ; Aged ; Anticoagulants/adverse effects ; Casts, Surgical ; Dalteparin/adverse effects ; Double-Blind Method ; Female ; Fibrinolytic Agents/adverse effects ; Fracture Fixation/adverse effects ; Fracture Fixation/methods ; Humans ; Injections, Subcutaneous ; Male ; Middle Aged ; Orthotic Devices ; Postoperative Complications/diagnosis ; Postoperative Complications/prevention & control ; Prospective Studies ; Risk Factors ; Time Factors ; Venous Thrombosis/diagnosis

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.
Interpretation: 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.

0 (Anticoagulants)
0 (Fibrinolytic Agents)
S79O08V79F (Dalteparin)

Date Created: 20071030 Date Completed: 20071119 Latest Revision: 20220318

20221213

10.1080/17453670710014185

17966008