Clinical trial NCT01557725: Frequency of Vascular Events With Short-term Thromboprophylaxis in Fast-track Hip and Knee-arthroplasty.
Official title: Frequency of Vascular Events With Short-term Thromboprophylaxis in Fast-track Hip and Knee-arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thromboembolic Events
Post-operative Bleeding
Keywords: Knee Replacement, Total
Hip Replacement, Total
Thromboembolism, Venous
prophylaxis
Enhanced recovery
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2012-03-19
Enrollment: 4924
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient receiving elective fast-track THR or TKR

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of Vascular events
timeFrame: 90 days postop
Secondary outcomes:
measure: Risk factors of vascular events
timeFrame: 90days postop
Other outcomes:
measure: bleeding events after total hip or knee arthroplasty
timeFrame: 2 days after last dose of prophylaxis
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University hospital
state: Judland
city: Farsoe
country: Denmark
facility: Farsoe Hospital
state: Judland
city: Grindsted
country: Denmark
facility: Sydvestjydsk Sygehus
state: Judland
city: Holstebro
country: Denmark
facility: Holstebro Hospital
state: Judland
city: Vejle
country: Denmark
facility: Vejle hospital
state: Judland
city: Hvidovre
country: Denmark
facility: Hvidovre University hospital
state: Seeland
Study officials:
affiliation: Section of surgical pathophysiology, 4074, Rigshospitalet, Copenhagen University, Copenhagen.
name: Christoffer C Joergensen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Section of surgical pathophysiology, 4074 Rigshospitalet, Copenhagen University
name: Henrik Kehlet, Professor
role: STUDY_CHAIR
affiliation: Aarhus University hospital, Orthopaedic department E
name: Kjeld Soeballe, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.