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Major joint replace...
Major joint replacement. A model for antithrombotic drug development: from proof-of-concept to clinical use
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Dahl, O. E. (författare)
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Borris, L. C. (författare)
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Bergqvist, D. (författare)
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visa fler...
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Schnack Rasmussen, M. (författare)
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- Eriksson, Bengt I., 1946 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper,Institute of Clinical Sciences
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Kakkar, A. K. (författare)
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Colwell, C. W. (författare)
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Caprini, J. A. (författare)
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Fletcher, J. (författare)
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Friedman, R. J. (författare)
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Lassen, M. R. (författare)
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Frostick, S. P. (författare)
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Sakon, M. (författare)
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Kwong, L. M. (författare)
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Kakkar, V. V. (författare)
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visa färre...
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(creator_code:org_t)
- 2008
- 2008
- Engelska.
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Ingår i: International angiology. - 0392-9590. ; 27:1, s. 60-7
- Relaterad länk:
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https://gup.ub.gu.se...
Abstract
Ämnesord
Stäng
- AIM: Development of antithrombotic compounds has traditionally been performed in patients undergoing total hip and knee replacement surgery. A high number of asymptomatic deep-vein thromboses are radiologically detectable, and bleeding and other adverse events (AE) are easy to observe. However, standardization of study procedures and endpoints in early proof-of-concept studies and late pure clinical endpoint studies has been lacking. This has made comparison between studies difficult, economic analyses speculative and potential benefits of applying the drug regimen in non-selected patients uncertain. In this paper, the International Surgical Thrombosis Forum proposes a strategy for the clinical investigation of new pharmacological agents for the prophylaxis of postoperative thrombotic events. METHODS: First, dose titration safety studies of short duration, in highly selected patients using objective venographic endpoints are recommended. Bleeding should be divided into the quantified volume of surgical bleeding and other adjudicated clinical bleeding events. The number of AE should be described for each dose step and classified according to International Coding of Diagnoses (ICD). Second, a dose confirmatory study of moderate exposure period and sufficient follow-up time is recommended. The exclusion criteria should be restricted to contraindications of the compared drugs and technical procedure. RESULTS: The efficacy, bleeding and AE should be similar to those used in dose-titration studies. In addition, the failure rate of the drug to exert its effect and the net clinical benefit should be calculated. CONCLUSION: Finally, trials with simple clinical endpoints and long follow-up should be conducted to evaluate the potential benefits of the drug-regimen in non-selected populations.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kirurgi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Surgery (hsv//eng)
Nyckelord
- *Arthroplasty
- Replacement
- Clinical Protocols
- Dose-Response Relationship
- Drug
- Drug Evaluation/*methods
- Fibrinolytic Agents/*administration & dosage
- Humans
- Postoperative Complications/*prevention & control
- Thromboembolism/prevention & control
- Venous Thrombosis/*prevention & control
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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Dahl, O. E.
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Borris, L. C.
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Bergqvist, D.
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Schnack Rasmusse ...
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Eriksson, Bengt ...
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Kakkar, A. K.
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visa fler...
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Colwell, C. W.
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Caprini, J. A.
-
Fletcher, J.
-
Friedman, R. J.
-
Lassen, M. R.
-
Frostick, S. P.
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Sakon, M.
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Kwong, L. M.
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Kakkar, V. V.
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visa färre...
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Kirurgi
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International an ...
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Göteborgs universitet