Use of heparins in patients with cancer
Schunemann, Holger J. ;  Ventresca, Matthew ;  Crowther, Mark ;  Briel, Matthias ;  Zhou, Qi ;  Garcia, David ;  Lyman, Gary ;  Noble, Simon ;  Macbeth, Fergus ;  Griffiths, Gareth ;  DiNisio, Marcello ;  Iorio, Alfonso ;  Beyene, Joseph ;  Mbuagbaw, Lawrance ;  Neumann, Ignacio ;  Van Es, Nick ;  Brouwers, Melissa ;  Brozek, Jan ;  Guyatt, Gordon ;  Levine, Mark ;  Moll, Stephan ;  Santesso, Nancy ;  Streiff, Michael ;  Baldeh, Tejan ;  Florez, Ivan ;  Alma, Ozlem Gurunlu ;  Solh, Ziad ;  Ageno, Walter ;  Marcucci, Maura ;  Bozas, George ;  Zulian, Gilbert ;  Maraveyas, Anthony ;  Lebeau, Bernard ;  Buller, Harry ;  Evans, Jessica ;  McBane, Robert ;  Bleker, Suzanne ;  Pelzer, Uwe ;  Akl, Elie A.

HaupttitelUse of heparins in patients with cancer
Titelzusatzindividual participant data meta-analysis of randomised trials study protocol
AutorSchunemann, Holger J.
AutorVentresca, Matthew
AutorCrowther, Mark
AutorBriel, Matthias
AutorZhou, Qi
AutorGarcia, David
AutorLyman, Gary
AutorNoble, Simon
AutorMacbeth, Fergus
AutorGriffiths, Gareth
AutorDiNisio, Marcello
AutorIorio, Alfonso
AutorBeyene, Joseph
AutorMbuagbaw, Lawrance
AutorNeumann, Ignacio
AutorVan Es, Nick
AutorBrouwers, Melissa
AutorBrozek, Jan
AutorGuyatt, Gordon
AutorLevine, Mark
AutorMoll, Stephan
AutorSantesso, Nancy
AutorStreiff, Michael
AutorBaldeh, Tejan
AutorFlorez, Ivan
AutorAlma, Ozlem Gurunlu
AutorSolh, Ziad
AutorAgeno, Walter
AutorMarcucci, Maura
AutorBozas, George
AutorZulian, Gilbert
AutorMaraveyas, Anthony
AutorLebeau, Bernard
AutorBuller, Harry
AutorEvans, Jessica
AutorMcBane, Robert
AutorBleker, Suzanne
AutorPelzer, Uwe
AutorAkl, Elie A.
Seitenzahl11 S.
DDC610 Medizin und Gesundheit
Auch erschienen inBMJ Open. - 6 (2016), 4, Artikel Nr. e010569
ZusammenfassungIntroduction Parenteral anticoagulants may improve outcomes in patients with cancer by reducing risk of venous thromboembolic disease and through a direct antitumour effect. Study-level systematic reviews indicate a reduction in venous thromboembolism and provide moderate confidence that a small survival benefit exists. It remains unclear if any patient subgroups experience potential benefits.

Methods and analysis First, we will perform a comprehensive systematic search of MEDLINE, EMBASE and The Cochrane Library, hand search scientific conference abstracts and check clinical trials registries for randomised control trials of participants with solid cancers who are administered parenteral anticoagulants. We anticipate identifying at least 15 trials, exceeding 9000 participants. Second, we will perform an individual participant data meta-analysis to explore the magnitude of survival benefit and address whether subgroups of patients are more likely to benefit from parenteral anticoagulants. All analyses will follow the intention-to-treat principle. For our primary outcome, mortality, we will use multivariable hierarchical models with patient-level variables as fixed effects and a categorical trial variable as a random effect. We will adjust analysis for important prognostic characteristics. To investigate whether intervention effects vary by predefined subgroups of patients, we will test interaction terms in the statistical model. Furthermore, we will develop a risk-prediction model for venous thromboembolism, with a focus on control patients of randomised trials.

Ethics and dissemination Aside from maintaining participant anonymity, there are no major ethical concerns. This will be the first individual participant data meta-analysis addressing heparin use among patients with cancer and will directly influence recommendations in clinical practice guidelines. Major cancer guideline development organisations will use eventual results to inform their guideline recommendations. Several knowledge users will disseminate results through presentations at clinical rounds as well as national and international conferences. We will prepare an evidence brief and facilitate dialogue to engage policymakers and stakeholders in acting on findings.

Trial registration number PROSPERO CRD42013003526
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Fachbereich/EinrichtungMedizinische Fakultät Charité - Universitätsmedizin Berlin
Dokumententyp/-SammlungenWissenschaftlicher Artikel
RechteCreative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Anmerkungen des AutorsDer Artikel wurde in einer Open-Access-Zeitschrift publiziert.
Erstellt am07.07.2016 - 08:58:57
Letzte Änderung07.07.2016 - 09:00:36
Statische URLhttp://edocs.fu-berlin.de/docs/receive/FUDOCS_document_000000024955