Last updated: 11/07/2018 16:16:49
A multicenter, multinational, randomized, double-blind study of fondaparinux sodium (Org31540/SR90107A) versus placebo for the prolonged prevention of VTE in hip fracture surgery. (PENTIHFRA PLUS)
Clinicaltrials.gov ID
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EudraCT ID
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EU CT Number
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Trial status
Study complete
Study complete
Trial overview
Official title: A multicenter, multinational, randomized, double-blind study of fondaparinux sodium (Org31540/SR90107A) versus placebo for the prolonged prevention of VTE in hip fracture surgery. (PENTIHFRA PLUS)
Trial description: A multicenter, multinational, randomized, double-blind study of fondaparinux sodium (Org31540/SR90107A) versus placebo for the prolonged prevention of VTE in hip fracture surgery. (PENTIHFRA PLUS)
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Abstract: Absence of transaminase increase after 4-week administration of fondaparinux (arixtra), a new synthetic and selective inhibitor of factor xa, in the penthifra-plus study. Lassen, M. , Bauer, K. A. , Eriksson, B. I. , and Turpie, A. G. G. 1 19th Congress of the International Society on Thrombosis and Haemostasis and 49th Annual Scientific and Standardisation Committee Meeting 7/12/2003 Birmingham; UK
Abstract: Consistency of efficacy of extended thromboprophylaxis with fondaparinux (arixtra) in prevention of venous thromboembolism (vte) after hip fracture surgery according to different composite efficacy endpoints: the penthifra- plus study. Eriksson B. I., Lassent M. R. 19th Congress of the International Society on Thrombosis and Haemostasis and 49th Annual Scientific and Standardisation Committee Meeting 7/12/2003 Birmingham; UK
Abstract: Efficacy of extended thromboprophylaxis with fondaparinux on secondary measures of thromboembolism. Louis M Kwong, Bengt Eriksson Michael Rud Lassen Moderators Daniel J Berry MD William J Hozack 71st Annual Meeting of the American Academy of Orthopaedic Surgeons 3/10/2004 San Francisco, CA; USA
Abstract: Efficacy of fondaparinux (arixtra) in extended thromboprophylaxis in hip fracture surgery is irrespective of
Abstract: Fondaparinux reduces long-term risk of venous thromboembolism after surgery for hip fracture. Alexander G. Turpie, Chffod w. Colwell, MD, Kenneth Bauer, MD, Bengt . Eriksson, MD, and Michael R. Lassen, MD. 69th Annual Meeting of the American College of Chest Physicians 10/25/2003 Orlando, FL, USA
Abstract: Influence of the duration of fondaparinux prophylaxis in preventing venous thromboembolism (vte) following major orthopedic surgery. Eriksson B., Bauert K. A. Lassen M. R. Turpie A. G. G. 19th Congress of the International Society on Thrombosis and Haemostasis and 49th Annual Scientific and Standardisation Committee Meeting 7/12/2003
Abstract: Influence of the duration of fondaparinux prophylaxis in preventing venous thromboembolism following hip fracture surgery. B.. Eriksson, ' K. A. Bauer M. R. Lassen A. G. Turpie D. A. Smithe. Annual Meeting of the American Geriatrics Society 5/14/2003 Orlando, FL, USA
Abstract: No episode of thrombocytopenia after four-week administration of fondaparinux, a new synthetic and selective inhibitor of factor xa, in the penthifra-plus study. Bauer, K. A., Lassen, M. R., Turpie,
Abstract: No episode of thrombocytopenia after four-week administration of fondaparinux, a new synthetic and selective inhibitor of factor xa, in the penthifra-plus study. M.R. Lassen, B. l. Eriksson 9th Congress of the European Haematology Association 6/10/2004 Geneva, Switzerland
Abstract: Persistence of the risk of venous thromboembolism (vte) for at least four weeks after hip fracture surgery: evidence from the fondaparinux hip fracture surgery database. Eriksson, B. I. and Lassen, M. R. 19th Congress of the International Society on Thrombosis and Haemostasis and 49th Annual Scientific and Standardisation Committee Meeting 7/12/2003 Birmingham; UK
Abstract: Serum transaminases do not increase after four-week administration of fondaparinux. NI.R. Lassen', B. l. Eriksson 2 21st World Congress of the International Union of Angiology 5/22/2004 Rome, Italy
Abstract: no episode of thrombocytopenia after four-week fonda-parinux in major orthopedic surgery. Lassen, M. R. and Eriksson, B. I. 21st World Congress of the International Union of Angiology 5/22/2004 Rome; Italy
Eriksson B. Duration of prophylaxis against venous thromboembolism with fondaparinux after hip fracture surgery. A multicenter, randomized, PBO-controlled, double-blind study. The Penthifra Plus Study. Arch Int Med 2003;163: 1337-42.
Extending prophylaxis with fondaparinux in preventing venous thromboembolism following hip fracture is cost-effective, Van Hout, European Association of Hospital Pharmacists, Sevilla, Spain, March 17-19, 2004.
Improvements in the prevention of postoperative venous thromboembolism in hip fracture patients. Eriksson, B. I. Orthopedics 2003; 26(8 Suppl):s851-8
Influence of the duration of fondaparinux prophylaxis in preventing venous thromboembolism (VTE) following major orthopaedic surgery (MOS), Eriksson, World Congress of Anaesthesiologists, Paris, France, April 18-23, 2004.
No episode of thrombocytopenia after four-week administration of fondaparinux, a new synthetic and selective inhibitor of factor Xa, in the PENTHIFRA-PLUS study, Lassen, European Hematology Association, Geneva, Switzerland, June 10-13, 2004.
No episode of thrombocytopenia after four-week fondaparinux (Arixtra), a synthetic and selective inhibitor of factor Xa, in major orthopaedic surgery, Lassen, European Association of Hospital Pharmacists, Sevilla, Spain, March 17-19, 2004.
No episode of thrombocytopenia after four-week fondaparinux in major orthopaedic surgery, Lassen, International Union of Angiology, Rome, Italy, May 22-26, 2004. ( oral)
Serum transaminases do not increase after four-week administration of fondaparinux, a synthetic and selective inhibitor of factor Xa, in major orthopaedic surgery, Lassen, European Association of Hospital Pharmacists, Sevilla, Spain, March 17-19, 2004.
patient and surgical characteristics: subgroup analyses of the penthifra-plus study. Lassen, M. R. and Eriksson, B. I. 19th Congress of the International Society on Thrombosis and Haemostasis and 49th Annual Scientific and Standardisation Committee Meeting 7/12/2003 Birmingham; UK
Medical condition
Thrombosis, Venous
Product
fondaparinux sodium
Collaborators
Not applicable
Study date(s)
N/A to Invalid Date
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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