Frequency of Vascular Events With Short-term Thromboprophylaxis in Fast-track Hip and Knee-arthroplasty. (FETA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01557725
Recruitment Status : Completed
First Posted : March 19, 2012
Last Update Posted : December 15, 2015
Information provided by (Responsible Party):
Christoffer Joergensen, Rigshospitalet, Denmark

March 16, 2012
March 19, 2012
December 15, 2015
February 2010
May 2013   (Final data collection date for primary outcome measure)
Frequency of Vascular events [ Time Frame: 90 days postop ]
Frequency of symptomatic deep venous thrombosis, pulmonary embolus, acute myocardial infarction, ischemic stroke and other vascular events and/or death
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Complete list of historical versions of study NCT01557725 on Archive Site
Risk factors of vascular events [ Time Frame: 90days postop ]
Assessment of preoperative risk factors, and their influence on risk of vascular events after hip and knee arthroplasty
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bleeding events after total hip or knee arthroplasty [ Time Frame: 2 days after last dose of prophylaxis ]
Assessment of any major bleeding events possibly related to thrombosis prophylaxis after surgery
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Frequency of Vascular Events With Short-term Thromboprophylaxis in Fast-track Hip and Knee-arthroplasty.
Frequency of Vascular Events With Short-term Thromboprophylaxis in Fast-track Hip and Knee-arthroplasty

There are many different views regarding ideal duration and type of thromboprophylaxis after hip or knee surgery.

An important factor in Fast-track surgery is early mobilization, which in itself is thought to prevent clotting.

The investigators hypothesize that there is no increase with regards to thrombosis in patients receiving fast-track surgery with early mobilization and chemical thrombosis prophylaxis only during hospitalization.

Major orthopaedic surgery is related to development of thrombosis. It is well known that pharmacological prophylaxis reduces the risk of thrombosis after surgery but there are still doubt about the best type of prophylaxis and duration of treatment. The American College of Chest Physicians recommend thromboprophylaxis with either Low molecular weight heparin, factor Xa-inhibitors or Vitamin-K-antagonists for up til 10 days after total knee replacement (TKR) and 35 days after total hip replacement(THR). However whether these recommendations are applicable in fast-track patients receiving early mobilisation is uncertain.

Studies on fast-track patients receiving early mobilisation and thrombosis prophylaxis only during hospitalisation showed very small incidence of symptomatic thromboembolic events. Therefore we conduct a quality-cohort-study on all patients receiving fast-track TKR/THR with short-term anti-thrombotic treatment, in order to investigate frequency of symptomatical deep vein thrombosis, pulmonary embolus, acute myocardial infarction and stroke.

Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Any patient receiving elective fast-track THR or TKR
  • Thromboembolic Events
  • Post-operative Bleeding
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THR/TKR patients
Any patients receiving fast-track THR or TKR in departments participating in the Lundbeck Foundation Centre for fast-track THR and TKR
Jørgensen CC, Jacobsen MK, Soeballe K, Hansen TB, Husted H, Kjærsgaard-Andersen P, Hansen LT, Laursen MB, Kehlet H. Thromboprophylaxis only during hospitalisation in fast-track hip and knee arthroplasty, a prospective cohort study. BMJ Open. 2013 Dec 10;3(12):e003965. doi: 10.1136/bmjopen-2013-003965. Erratum in: BMJ Open. 2014;4(6):e003965.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2013
May 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • primary Uni/bilateral THR/TKR, revision THR/TKR or uni-KR in fast-track setup, Discharged in 3 +-2 days.

Exclusion Criteria:

  • not a danish citizen
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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Christoffer Joergensen, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Not Provided
Principal Investigator: Christoffer C Joergensen, MD Section of surgical pathophysiology, 4074, Rigshospitalet, Copenhagen University, Copenhagen.
Study Chair: Henrik Kehlet, Professor Section of surgical pathophysiology, 4074 Rigshospitalet, Copenhagen University
Study Chair: Kjeld Soeballe, Professor Aarhus University hospital, Orthopaedic department E
Rigshospitalet, Denmark
December 2015