Single-dose TB-402 or rivaroxaban for the prevention of venous thromboembolism after total hip replacement

2013 ◽  
Vol 109 (06) ◽  
pp. 1091-1098 ◽  
Author(s):  
Sophie Gunn ◽  
Elisabeth Sonesson ◽  
Kathelijne Peerlinck ◽  
Thomas Vanassche ◽  
Christophe Vandenbriele ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Total Hip Replacement ◽  
Major Bleeding ◽  
Hip Replacement ◽  
Similar Efficacy ◽  
Double Blind Study ◽  
Single Administration ◽  
Double Blind ◽  
Total Hip ◽  
Safety Outcome

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.

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

The Lancet ◽  
2007 ◽  
Vol 370 (9591) ◽  
pp. 949-956 ◽  
Author(s):  
Bengt I Eriksson ◽  
Ola E Dahl ◽  
Nadia Rosencher ◽  
Andreas A Kurth ◽  
C Niek van Dijk ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Total Hip Replacement ◽  
Hip Replacement ◽  
Dabigatran Etexilate ◽  
Double Blind ◽  
Total Hip

scholarly journals Safety of apixaban in Indian patients undergoing elective total knee replacement or total hip replacement surgery: A multi-center, phase-IV study

2021 ◽  
Vol 9 ◽  
pp. 205031212110499
Author(s):  
Himanshu Panchal ◽  
Abhijit Agashe ◽  
Parag K Sancheti ◽  
Namrata B Kulkarni ◽  
Santosh R Taur
Keyword(s):  
Venous Thromboembolism ◽  
Total Knee Replacement ◽  
Total Hip Replacement ◽  
Knee Replacement ◽  
Major Bleeding ◽  
Hip Replacement ◽  
Total Hip ◽  
Indian Patients ◽  
Total Knee ◽  
Phase Iv

Background: Venous thromboembolism is a significant source of morbidity and mortality following total hip replacement and total knee replacement. Apixaban has been proven to be efficacious without increased risk of bleeding in phase-III trials in patients undergoing total knee replacement and total hip replacement. Due to paucity of data on safety of apixaban in Indian patients, this phase-IV study was conducted to evaluate safety of apixaban in patients undergoing total knee replacement and total hip replacement. Methods: In this non-comparative phase-IV clinical trial, patients undergoing elective total knee replacement or total hip replacement surgery, or a revision of at least one component of total knee replacement or total hip replacement, were enrolled. The eligible patients were given the approved dosage of apixaban 12 to 24 h after completing the skin wound closure. The primary safety outcome was the composite of the International Society on Thrombosis and Haemostasis–defined major bleeding and clinically relevant non-major bleeding events at the end of the treatment. The secondary efficacy endpoint was the composite of venous thromboembolism/all-cause death at the end of the treatment. Results: A total of 498 patients received apixaban prophylaxis therapy. Six (1.2%) bleeding adverse events were observed during the treatment period. Only one bleeding event was adjudicated as an International Society on Thrombosis and Haemostasis–defined clinically relevant non-major bleeding event (moderate severity). There were no fatal bleeding events and no deaths following the treatment. One venous thromboembolism event, that is, symptomatic distal left leg DVT, was reported in a total knee replacement patient and was adjudicated during the treatment period. Conclusion: Apixaban demonstrated a favorable safety profile for venous thromboembolism prevention in Indian patients undergoing total knee replacement or total hip replacement.

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

1991 ◽  
Vol 66 (06) ◽  
pp. 652-656 ◽  
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.

Direct thrombin inhibitor melagatran followed by oral ximelagatran in comparison with enoxaparin for prevention of venous thromboembolism after total hip or knee replacement

2003 ◽  
Vol 89 (02) ◽  
pp. 288-296 ◽  
Author(s):  
Giancarlo Agnelli ◽  
Alexander Cohen ◽  
Ola Dahl ◽  
Patrick Mouret ◽  
Nadia Rosencher ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Knee Replacement ◽  
Thrombin Inhibitors ◽  
Thrombin Inhibitor ◽  
Direct Thrombin Inhibitors ◽  
Double Blind Study ◽  
Double Blind ◽  
Total Hip ◽  
Vein Thrombosis ◽  
Major Orthopaedic Surgery

SummaryWe evaluated whether a postoperative regimen with melagatran followed by oral ximelagatran, two new direct thrombin inhibitors, was an optimal regimen for thromboprophylaxis in major orthopaedic surgery. In a double-blind study, 2788 patients undergoing total hip or knee replacement were randomly assigned to receive for 8 to 11 days either 3 mg of subcutaneous melagatran started 4-12 h postoperatively, followed by 24 mg of oral ximelagatran twice-daily or 40 mg of subcutaneous enoxaparin once-daily, started 12 h preoperatively. Ximelagatran was to be initiated within the first two postoperative days. The primary efficacy endpoint was venous thromboembolism (deep-vein thrombosis detected by mandatory venography, pulmonary embolism or unexplained death). The main safety endpoint was bleeding. Venous thromboembolism occurred in 355/1146 (31.0%) and 306/1122 (27.3%) patients in the ximelagatran and enoxaparin group, respectively, a difference in risk of 3.7% in favour of enoxaparin (p = 0.053). Bleeding was comparable between the two groups.

Sign in / Sign up

Export Citation Format

Share Document