Frequency of Vascular Events With Short-term Thromboprophylaxis in Fast-track Hip and Knee-arthroplasty. (FETA)
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Purpose
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.
| Condition |
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Thromboembolic Events Post-operative Bleeding |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Frequency of Vascular Events With Short-term Thromboprophylaxis in Fast-track Hip and Knee-arthroplasty |
- Frequency of Vascular events [ Time Frame: 90 days postop ] [ Designated as safety issue: No ]Frequency of symptomatic deep venous thrombosis, pulmonary embolus, acute myocardial infarction, ischemic stroke and other vascular events and/or death
- Risk factors of vascular events [ Time Frame: 90days postop ] [ Designated as safety issue: No ]Assessment of preoperative risk factors, and their influence on risk of vascular events after hip and knee arthroplasty
- bleeding events after total hip or knee arthroplasty [ Time Frame: 2 days after last dose of prophylaxis ] [ Designated as safety issue: Yes ]Assessment of any major bleeding events possibly related to thrombosis prophylaxis after surgery
| Estimated Enrollment: | 15000 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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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
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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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Any patient receiving elective fast-track THR or TKR
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
Contacts and Locations| Contact: Christoffer C Joergensen, MD | +4535454616 | christoffer.calov.joergensen@rh.regionh.dk |
| Denmark | |
| Aarhus University hospital | Recruiting |
| Aarhus, Judland, Denmark, 8000 | |
| Contact: Kjeld Soeballe, Proff, MD. soeballe@gmail.com | |
| Principal Investigator: Kjeld Soeballe, MD. | |
| Farsoe Hospital | Recruiting |
| Farsoe, Judland, Denmark, 9640 | |
| Principal Investigator: Mogens B Laursen, M.D. | |
| Sydvestjydsk Sygehus | Recruiting |
| Grindsted, Judland, Denmark, 7200 | |
| Principal Investigator: Lars T Hansen, MD. | |
| Holstebro Hospital | Recruiting |
| Holstebro, Judland, Denmark, 7500 | |
| Principal Investigator: Torben B Hansen, M.D. | |
| Vejle hospital | Recruiting |
| Vejle, Judland, Denmark, Vejle | |
| Principal Investigator: Per Kjærsgaard-Andersen, M.D | |
| Hvidovre University hospital | Recruiting |
| Hvidovre, Seeland, Denmark, 2650 | |
| Principal Investigator: Henrik Husted, M.D | |
| Principal Investigator: | Christoffer C Joergensen, MD | Section of surgical pathophysiology, 4074, Rigshospitalet, Copenhagen University, Copenhagen. |
| Study Chair: | Henrik Kehlet, Professor | Section of surgical pathophysiology, 4074 Rigshospitalet, Copenhagen University |
| Study Chair: | Kjeld Soeballe, Professor | Aarhus University hospital, Orthopaedic department E |
More Information
No publications provided
| Responsible Party: | Christoffer Joergensen, research fellow/MD, Rigshospitalet, Denmark |
| ClinicalTrials.gov Identifier: | NCT01557725 History of Changes |
| Other Study ID Numbers: | RH7621 |
| Study First Received: | March 16, 2012 |
| Last Updated: | February 5, 2013 |
| Health Authority: | Denmark: Danish Dataprotection Agency |
Keywords provided by Rigshospitalet, Denmark:
|
Knee Replacement, Total Hip Replacement, Total Thromboembolism, Venous prophylaxis Enhanced recovery |
Additional relevant MeSH terms:
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Hemorrhage Postoperative Hemorrhage Thromboembolism Embolism Pathologic Processes |
Postoperative Complications Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thrombosis |
ClinicalTrials.gov processed this record on June 18, 2013