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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christoffer Joergensen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01557725
First received: March 16, 2012
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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
Thromboembolic Events
Post-operative Bleeding

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Frequency of Vascular Events With Short-term Thromboprophylaxis in Fast-track Hip and Knee-arthroplasty

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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


Enrollment: 4924
Study Start Date: February 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any patient receiving elective fast-track THR or TKR

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01557725

Locations
Denmark
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
Investigators
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
  More Information

No publications provided

Responsible Party: Christoffer Joergensen, research fellow/MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01557725     History of Changes
Other Study ID Numbers: RH7621
Study First Received: March 16, 2012
Last Updated: December 16, 2013
Health Authority: Denmark: Danish Dataprotection Agency

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

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

ClinicalTrials.gov processed this record on September 18, 2014