Faculty Opinions recommendation of Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial.

SummaryTB-402 is a long-acting monoclonal antibody that partially inhibits factor VIII. A single administration of TB-402 was effective and well-tolerated for the prevention of venous thromboembolism (VTE) after total knee replacement. In this study, the efficacy and safety of a single administration of TB-402 for the extended prophylaxis of VTE after total hip replacement (THR) was investigated. This was a phase II, randomised, active-controlled, double-blind study that included patients undergoing elective THR surgery. Patients were randomised to TB-402 25 mg or TB-402 50 mg, administered as a single intravenous administration 2–4 hours postoperatively, or to rivaroxaban 10 mg once daily for 35 days. The primary efficacy outcome was total VTE defined as symptomatic VTE and asymptomatic deep-vein thrombosis (DVT) detected by bilateral venography at day 35. The principal safety outcome was the incidence of major bleeding and clinically relevant non-major bleeding until day 35. Total VTE was similar in all groups: 5.3% (95%CI 2.9–9.6), 5.2% (95%CI 2.8–9.3) and 4.7% (95%CI 2.5–8.7) for TB-402 25 mg, TB-402 50 mg and rivaroxaban, respectively. All were asymptomatic DVTs. Major or clinically relevant non-major bleedings were observed in 5.8% (95%CI 3.3–9.9), 7.2% (95%CI 4.4–11.6) and 1.4% (95%CI 0.5–4.2) for TB-402 25 mg, TB-402 50 mg and rivaroxaban, respectively. In conclusion, TB-402, administered as a single postoperative dose, had a similar efficacy compared to rivaroxaban for the prevention of VTE after THR. The incidence of major and clinically relevant non-major bleeding was higher in the TB-402 groups than in the rivaroxaban group.

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Effects on Coagulation and Fibrinolysis of Desmopressin in Patients Undergoing Total Hip Replacement

Thrombosis and Haemostasis ◽

10.1055/s-0038-1646480 ◽

1991 ◽

Vol 66 (06) ◽

pp. 652-656 ◽

Cited By ~ 7

Author(s):

Per Anders Flordal ◽

Karl-Gösta Ljungström ◽

Jan Svensson ◽

Brenda Ekman ◽

Gustaf Neander

Keyword(s):

Total Hip Replacement ◽

Hip Replacement ◽

Bleeding Time ◽

Antithrombin Iii ◽

Postoperative Bleeding ◽

Double Blind ◽

Total Hip ◽

Von Willebrand ◽

Willebrand Factor ◽

Coagulation And Fibrinolysis

SummaryTwelve patients undergoing total hip replacement, with regional anaesthesia and with dextran infusion for plasma expansion and thromboprophylaxis, were given the vasopressin analogue desmopressin (DDAVP) or placebo in a randomized, double-blind prospective study. In controls (n = 6) we found a prolongation of the bleeding time, low factor VIII (FVIII) and von Willebrand factor (vWF) and a decrease in antithrombin III to levels known to be at risk for venous thrombosis. Desmopressin shortened postoperative bleeding time, gave an early FVIII/vWF complex increase, prevented antithrombin III from falling to critically low values and appeared to activate the fibrinolytic system, both by tPA increase and PAI-1 decrease.Thus in the controls we found changes in both coagulation and fibrinolysis indicating a haemorrhagic diathesis as well as a risk for thromboembolism. Desmopressin induced factor changes that possibly reduce both risks.

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