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

Thromboembolic Events Clinical Trial

— FETA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01557725
• Other study ID #: RH7621
• Status: Completed
• Start date: February 2010
• Est. completion date: May 2013

Study information

• Verified date: January 2021
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4924
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post-operative Bleeding
• Postoperative Hemorrhage
• Thromboembolic Events
• Thromboembolism

Locations

Country	Name	City	State
Denmark	Aarhus University hospital	Aarhus	Judland
Denmark	Farsoe Hospital	Farsoe	Judland
Denmark	Sydvestjydsk Sygehus	Grindsted	Judland
Denmark	Holstebro Hospital	Holstebro	Judland
Denmark	Hvidovre University hospital	Hvidovre	Seeland
Denmark	Vejle hospital	Vejle	Judland

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (6)

Jørgensen CC, Jacobsen MK, Soeballe K, Hansen TB, Husted H, Kjærsgaard-Andersen P, Hansen LT, Laursen MB, Kehlet H. Thromboprophylaxis only during hospitalisation in fast-track hip and knee arthroplasty, a prospective cohort study. BMJ Open. 2013 Dec 10;3(12):e003965. doi: 10.1136/bmjopen-2013-003965. Erratum in: BMJ Open. 2014;4(6):e003965. — View Citation

Jørgensen CC, Kehlet H; Lundbeck Foundation Centre for Fast-track Hip and Knee replacement collaborative group. Early thromboembolic events =1week after fast-track total hip and knee arthroplasty. Thromb Res. 2016 Feb;138:37-42. doi: 10.1016/j.thromres.2015.12.025. Epub 2015 Dec 29. — View Citation

Petersen PB, Jørgensen CC, Gromov K, Kehlet H; Lundbeck Foundation Centre for Fast-track Hip and Knee Replacement Collaborative Group. Venous thromboembolism after fast-track unicompartmental knee arthroplasty - A prospective multicentre cohort study of 3927 procedures. Thromb Res. 2020 Nov;195:81-86. doi: 10.1016/j.thromres.2020.07.002. Epub 2020 Jul 4. — View Citation

Petersen PB, Jørgensen CC, Kehlet H; Lundbeck Foundation Centre for Fast-track Hip Knee Replacement Collaborative Group. Venous Thromboembolism despite Ongoing Prophylaxis after Fast-Track Hip and Knee Arthroplasty: A Prospective Multicenter Study of 34,397 Procedures. Thromb Haemost. 2019 Nov;119(11):1877-1885. doi: 10.1055/s-0039-1696686. Epub 2019 Oct 6. — View Citation

Petersen PB, Kehlet H, Jørgensen CC; Lundbeck Foundation Centre for Fast-track Hip and Knee Replacement Collaborative Group. Safety of In-Hospital Only Thromboprophylaxis after Fast-Track Total Hip and Knee Arthroplasty: A Prospective Follow-Up Study in 17,582 Procedures. Thromb Haemost. 2018 Dec;118(12):2152-2161. doi: 10.1055/s-0038-1675641. Epub 2018 Nov 19. — View Citation

Petersen PB, Lindberg-Larsen M, Jørgensen CC, Kehlet H; Lundbeck Foundation Centre for Fast-track Hip and Knee Arthroplasty collaborating group. Venous thromboembolism after fast-track elective revision hip and knee arthroplasty - A multicentre cohort study of 2814 unselected consecutive procedures. Thromb Res. 2021 Jan 18;199:101-105. doi: 10.1016/j.thromres.2021.01.003. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	bleeding events after total hip or knee arthroplasty	Assessment of any major bleeding events possibly related to thrombosis prophylaxis after surgery	2 days after last dose of prophylaxis
Primary	Frequency of Vascular events	Frequency of symptomatic deep venous thrombosis, pulmonary embolus, acute myocardial infarction, ischemic stroke and other vascular events and/or death	90 days postop
Secondary	Risk factors of vascular events	Assessment of preoperative risk factors, and their influence on risk of vascular events after hip and knee arthroplasty	90days postop