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

This study is currently recruiting participants.
Verified February 2013 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
Christoffer Joergensen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01557725
First received: March 16, 2012
Last updated: February 5, 2013
Last verified: February 2013
History of Changes

March 16, 2012
February 5, 2013
February 2010
January 2015   (final data collection date for primary outcome measure)
Frequency of Vascular events [ Time Frame: 90 days postop ] [ Designated as safety issue: No ]
Frequency of symptomatic deep venous thrombosis, pulmonary embolus, acute myocardial infarction, ischemic stroke and other vascular events and/or death
Not Provided
Complete list of historical versions of study NCT01557725 on ClinicalTrials.gov Archive Site
Risk factors of vascular events [ Time Frame: 90days postop ] [ Designated as safety issue: No ]
Assessment of preoperative risk factors, and their influence on risk of vascular events after hip and knee arthroplasty
Not Provided
bleeding events after total hip or knee arthroplasty [ Time Frame: 2 days after last dose of prophylaxis ] [ Designated as safety issue: Yes ]
Assessment of any major bleeding events possibly related to thrombosis prophylaxis after surgery
Not Provided
 
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Any patient receiving elective fast-track THR or TKR
  • Thromboembolic Events
  • Post-operative Bleeding
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15000
January 2015
January 2015   (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
Both
18 Years and older
No
Contact: Christoffer C Joergensen, MD +4535454616 christoffer.calov.joergensen@rh.regionh.dk
Denmark
 
NCT01557725
RH7621
Yes
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
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP