Last updated: 11/07/2018 16:16:25
A multicenter, multinational, randomized double-blind comparison study of subcutaneous Org31540/SR90107A versus enoxaparin 40 mg o.d. in the prevention of deep vein thrombosis and symptomatic pulmonary embolism in hip fracture surgery. (PENTHIFRA)
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 comparison study of subcutaneous Org31540/SR90107A versus enoxaparin 40 mg o.d. in the prevention of deep vein thrombosis and symptomatic pulmonary embolism in hip fracture surgery. (PENTHIFRA)
Trial description: A multicenter, multinational, randomized double-blind comparison study of subcutaneous Org31540/SR90107A versus enoxaparin 40 mg o.d. in the prevention of deep vein thrombosis and symptomatic pulmonary embolism in hip fracture surgery. (PENTHIFRA)
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:
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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. 19th Congress of the International Society on Thrombosis and Haemostasis and 49th Annual Scientific and Standardisation Committee Meeting 7/12/2003 Birmingham; UK
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,
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, A. G. G., 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
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
Eriksson BI. Fondaparinux compared with enoxaparin for the prevention of venous thromboembolism after hip-fracture surgery. N Engl J Med 2001; 345: 298-1304.
Improvements in the prevention of postoperative venous thromboembolism in hip fracture patients. Eriksson, B. I. Orthopedics 2003; 26(8 Suppl):s851-8
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
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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