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

Brief Summary:

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.

Condition or disease
Thromboembolic Events Post-operative Bleeding

Detailed Description:

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.

Study Type : Observational
Actual Enrollment : 4924 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Frequency of Vascular Events With Short-term Thromboprophylaxis in Fast-track Hip and Knee-arthroplasty
Study Start Date : February 2010
Primary Completion Date : May 2013
Study Completion Date : May 2013

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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

Other Outcome Measures:
  1. 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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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patient receiving elective fast-track THR or TKR

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01557725

Aarhus University hospital
Aarhus, Judland, Denmark, 8000
Farsoe Hospital
Farsoe, Judland, Denmark, 9640
Sydvestjydsk Sygehus
Grindsted, Judland, Denmark, 7200
Holstebro Hospital
Holstebro, Judland, Denmark, 7500
Vejle hospital
Vejle, Judland, Denmark, Vejle
Hvidovre University hospital
Hvidovre, Seeland, Denmark, 2650
Sponsors and Collaborators
Rigshospitalet, Denmark
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Christoffer Joergensen, research fellow/MD, Rigshospitalet, Denmark Identifier: NCT01557725     History of Changes
Other Study ID Numbers: RH7621
First Posted: March 19, 2012    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015

Keywords provided by Christoffer Joergensen, Rigshospitalet, Denmark:
Knee Replacement, Total
Hip Replacement, Total
Thromboembolism, Venous
Enhanced recovery

Additional relevant MeSH terms:
Postoperative Hemorrhage
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Postoperative Complications