Frequency of Vascular Events With Short-term Thromboprophylaxis in Fast-track Hip and Knee-arthroplasty.
NCT ID: NCT01557725
Last Updated: 2021-01-27
Study Results
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Basic Information
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COMPLETED
4924 participants
OBSERVATIONAL
2010-02-28
2013-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Christoffer Joergensen
research fellow/MD
Principal Investigators
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Christoffer C Joergensen, MD
Role: PRINCIPAL_INVESTIGATOR
Section of surgical pathophysiology, 4074, Rigshospitalet, Copenhagen University, Copenhagen.
Henrik Kehlet, Professor
Role: STUDY_CHAIR
Section of surgical pathophysiology, 4074 Rigshospitalet, Copenhagen University
Kjeld Soeballe, Professor
Role: STUDY_CHAIR
Aarhus University hospital, Orthopaedic department E
Locations
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Aarhus University hospital
Aarhus, Judland, Denmark
Farsoe Hospital
Farsø, Judland, Denmark
Sydvestjydsk Sygehus
Grindsted, Judland, Denmark
Holstebro Hospital
Holstebro, Judland, Denmark
Vejle hospital
Vejle, Judland, Denmark
Hvidovre University hospital
Hvidovre, Region Sjælland, Denmark
Countries
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References
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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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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RH7621
Identifier Type: -
Identifier Source: org_study_id
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