Prolonged use of Dalteparin for thromboprophylaxis not effective in reducing DVT incidence .
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(11):130 Acta Orthop. 2007 Aug;78(4):528-35272 patients undergoing surgery for ankle fractures were included in this study. All patients received 5,000 U Dalteparin subcutaneously (once per day for 7 days) starting the day after surgery. Then, patients randomized to the intervention group received 5,000 U Dalteparin, and patients randomized to the control group received placebo, for 5 weeks. Patients received treatment drugs after surgery while their lower limb was either immobilized in a plaster cast or orthosis. The results following the immobilization period indicated no differences between the two groups with respect to the incidence of deep vein thrombosis (DVT). Prolonged use of Dalteparin as a method to prevent venous thromboembolism should be considered with caution.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Sì = 1
Incerto = 0,5
Non rilevante = 0
No = 0
La valutazione dei criteri di segnalazione valuta la trasparenza con cui gli autori riportano le caratteristiche metodologiche e sperimentali dello studio all'interno della pubblicazione. La valutazione è suddivisa in cinque categorie che vengono presentate di seguito.
2/4
Randomization
4/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
L'Indice di Fragilità è uno strumento che aiuta l'interpretazione dei risultati significativi, fornendo una misura della forza di un risultato. L'Indice di Fragilità rappresenta il numero di eventi consecutivi che devono essere aggiunti a un risultato dicotomico per rendere il risultato non più significativo. Un numero piccolo rappresenta un risultato più debole, mentre un numero grande rappresenta un risultato più forte.
Perché questo studio era necessario ora?
The trauma, surgical procedure, and immobilization that results from orthopaedic injuries increases an individual's risk for developing deep vein thrombosis (DVT's). The incidence of ankle fractures is more than 100 per 100,00 person years. There are a few different treatments available for displaced ankle fractures including immobilization using a plaster cast, and surgery followed by immobilization in plaster cast or orthosis. No agreement has been made regarding thomboprophylaxis when the lower limb is immobilized. This study was needed to determine the effectiveness of Dalteparin as a method of thromboprophylaxis in patients with ankle fractures and subsequent immobilization.
Qual era la domanda di ricerca principale?
Does Dalteparin safely and effectively manage the risk of DVT in patients undergoing ankle fracture fixation, as evaluated against a placebo over 6 weeks?
- The overall incidence of venous thromboembolism (identified by phlebography) was 21% (CI 13-29%) in the Dalteparin group and 28% (CI 19-37%) in the placebo group (p=0.25), odds ratio 0.7 (0.4-1.3).
- 4% (CI 0-8%) of patients in the Dalteparin group, and 3% (CI 0-6%) in the placebo group had a proximal DVT. No patients had PE.
- No major bleeding occurred in either of the groups.
Che cosa devo ricordare di più?
The results from this study indicated that immobilization after ankle surgery often resulted in distal deep vein thrombosis (DVT). There was no significant difference in the incidence of deep vein thrombosis between both groups.
Come influenzerà l'assistenza ai miei pazienti?
Futher studies are required to determine the effects of thromboprophylaxis for longer time periods. Prolonged use of Dalteparin as a method to prevent venous thromboembolism should be considered with caution.
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