Frequency of Vascular Events With Short-term Thromboprophylaxis in Fast-track Hip and Knee-arthroplasty. (FETA)
|ClinicalTrials.gov Identifier: NCT01557725|
Recruitment Status : Completed
First Posted : March 19, 2012
Last Update Posted : December 15, 2015
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|
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|
|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|
Any patients receiving fast-track THR or TKR in departments participating in the Lundbeck Foundation Centre for fast-track THR and TKR
- 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
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01557725
|Aarhus University hospital|
|Aarhus, Judland, Denmark, 8000|
|Farsoe, Judland, Denmark, 9640|
|Grindsted, Judland, Denmark, 7200|
|Holstebro, Judland, Denmark, 7500|
|Vejle, Judland, Denmark, Vejle|
|Hvidovre University hospital|
|Hvidovre, Seeland, Denmark, 2650|
|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|