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

Completed

• Conditions: Post-operative Bleeding; Thromboembolic Events

• Registration Number: NCT01557725
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-02
• Study First Submitted: 2012-03-16
• Study First Submitted QC: 2012-03-16
• Study First Posted: 2012-03-19
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4924

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of Vascular events	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

Name	Time	Method
Risk factors of vascular events	90days postop	Assessment of preoperative risk factors, and their influence on risk of vascular events after hip and knee arthroplasty

Trial Locations

Locations (6)

Sydvestjydsk Sygehus; 🇩🇰 Grindsted, Judland, Denmark

Farsoe Hospital; 🇩🇰 Farsoe, Judland, Denmark

Hvidovre University hospital; 🇩🇰 Hvidovre, Seeland, Denmark

Holstebro Hospital; 🇩🇰 Holstebro, Judland, Denmark

Vejle hospital; 🇩🇰 Vejle, Judland, Denmark

Aarhus University hospital; 🇩🇰 Aarhus, Judland, Denmark