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

NCT01557725 | Completed DMC

• 1 other identifier: RH7621
• Study Type: observational
• Target: 4,924
• Locations: 1 country
• Sites: 6

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.

Conditions

Thromboembolic Events; Post-operative Bleeding

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Risk factors of vascular events

  90days postop

Other Outcomes (1)

• bleeding events after total hip or knee arthroplasty

  2 days after last dose of prophylaxis

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient receiving elective fast-track THR or TKR

You may qualify if:

• primary Uni/bilateral THR/TKR, revision THR/TKR or uni-KR in fast-track setup, Discharged in 3 +-2 days.

You may not qualify if:

• not a danish citizen

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (6)

Aarhus University hospital

Aarhus, Judland, 8000, Denmark

Location

Farsoe Hospital

Farsø, Judland, 9640, Denmark

Location

Sydvestjydsk Sygehus

Grindsted, Judland, 7200, Denmark

Location

Holstebro Hospital

Holstebro, Judland, 7500, Denmark

Location

Vejle hospital

Vejle, Judland, Vejle, Denmark

Location

Hvidovre University hospital

Hvidovre, Region Sjælland, 2650, Denmark

Location

Related Publications (6)

• Petersen PB, Lindberg-Larsen M, Jorgensen 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 Mar;199:101-105. doi: 10.1016/j.thromres.2021.01.003. Epub 2021 Jan 18.

  PMID: 33485092 BACKGROUND

• Petersen PB, Jorgensen 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.

  PMID: 32673960 BACKGROUND

• Petersen PB, Jorgensen 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.

  PMID: 31587249 BACKGROUND

• Petersen PB, Kehlet H, Jorgensen 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.

  PMID: 30453352 BACKGROUND

• Jorgensen 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.

  PMID: 26826506 BACKGROUND

• Jorgensen CC, Jacobsen MK, Soeballe K, Hansen TB, Husted H, Kjaersgaard-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.

  PMID: 24334158 BACKGROUND

MeSH Terms

Conditions

Thromboembolism; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Christoffer C Joergensen, MD

  Section of surgical pathophysiology, 4074, Rigshospitalet, Copenhagen University, Copenhagen.

  PRINCIPAL INVESTIGATOR

• Henrik Kehlet, Professor

  Section of surgical pathophysiology, 4074 Rigshospitalet, Copenhagen University

  STUDY CHAIR

• Kjeld Soeballe, Professor

  Aarhus University hospital, Orthopaedic department E

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research fellow/MD

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 19, 2012
• Study Start: February 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

DK (6)