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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01557725
Acronym
FETA
Enrollment
4924
Registered
2012-03-19
Start date
2010-02-28
Completion date
2013-05-31
Last updated
2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative Bleeding, Thromboembolic Events

Keywords

Knee Replacement, Total, Hip Replacement, Total, Thromboembolism, Venous, prophylaxis, Enhanced recovery

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.

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.

Interventions

None listed

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Frequency of Vascular events90 days postopFrequency of symptomatic deep venous thrombosis, pulmonary embolus, acute myocardial infarction, ischemic stroke and other vascular events and/or death

Secondary

MeasureTime frameDescription
Risk factors of vascular events90days postopAssessment of preoperative risk factors, and their influence on risk of vascular events after hip and knee arthroplasty

Other

MeasureTime frameDescription
bleeding events after total hip or knee arthroplasty2 days after last dose of prophylaxisAssessment of any major bleeding events possibly related to thrombosis prophylaxis after surgery

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026