Thromosis thromboembolism hardvard 2018 download pdf

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Abstract International and national guidelines recommend low-molecular-weight heparin for the treatment of venous thromboembolism VTE in patients with cancer. The study is an investigator-initiated, multi-national, prospective, randomized, open-label with blind end-point evaluation PROBE , non- inferiority clinical trial NCT Consecutive patients are randomized to receive oral apixaban or subcutaneous dalteparin for 6 months.

The Caravaggio study has the potential, along with other recently performed or on-going studies, to make less cumbersome the management of VTE in patients with cancer by replacing parenteral with oral anticoagulation.

Introduction treatment in the majority of patients with VTE. Furthermore, patients with time of the presentation of VTE or in the year thereafter. In cancer patients have recently been published or are currently the CLOT study, dalteparin was associated with a statistically on-going.

These include the inconvenience of subcutaneous injections We report here the design of the Caravaggio study, a trial for at least 6 months in patients who are already receiving comparing the direct factor Xa inhibitor apixaban with the complex anti-cancer treatment and the risk for heparin- LMWH dalteparin for the treatment of acute VTE in patients induced thrombocytopaenia.

Furthermore, treatment with with cancer NCT LMWH is associated with the same risk for major bleeding as conventional treatment. Aim of the Study Direct oral anticoagulants DOACs were tested in six phase III studies on the treatment of acute VTE and were The aim of this study is to assess whether oral apixaban is shown by meta-analyses to be at least as effective as and non-inferior to subcutaneous LMWH dalteparin for the safer than the conventional treatment.

Thrombosis and Haemostasis Vol. The national, prospective, randomized, open-label with blind study has been planned to be conducted in centres in 10 end-point evaluation PROBE , non-inferiority clinical trial. European countries and in the United States. The assessment of the study outcomes those undergoing imaging for purposes of cancer diagnosis, made by a central independent adjudication committee una- staging, re-staging or surveillance and not be clinically ware of study treatment allocation is a reasonable guarantee of suspected at the time of detection.

Patients with incidental the appropriateness as well as the consistency of the assess- VTE may not necessarily be asymptomatic, as they often ment of study outcome events in the two treatment groups.

In cohort studies, the risks of recurrence, anticoagulation-related Study Population and Eligibility This document was downloaded for personal use only. To be included in the study, patients with incidental DVT need to have thrombosis Study Treatments and Treatment Allocation located in the popliteal or a more proximal vein and inci- dental PE emboli involving a segmental or more proximal All patients included in the Caravaggio study receive antic- pulmonary artery.

Administration of therapeutic doses of in the online version. The study treatments are For the purpose of this study, patients with active cancer given for 6 months. The maximum Group stage and life expectancy , issues related to antic- daily dose allowed for dalteparin is 18, IU.

The regimen oagulant treatment, issues related to bleeding risk and chosen for dalteparin is the same as validated in the CLOT standard exclusion criteria for clinical trials with anticoagu- study. PE is to be of the overall study population for each of the strata as only a adjudicated as the cause of death based on objective diag- limited proportion of these patients were included in rando- nostic testing made before death or autopsy or when PE is the mized clinical trials on VTE treatment in cancer patients.

Among patients with a cate all suspected study outcomes and all deaths occurring history of cancer, recurrent VTE occurred in 1. Clinical examination, laboratory and diagnostic apixaban is non-inferior to the subcutaneous LMWH dalte- imaging are performed if the patient develops symptoms or parin for the treatment of VTE in patients with cancer.

The signs suggestive of recurrent VTE. These objectives deal with unmet clinical needs in The study hypothesis is that apixaban is non-inferior to the setting of the VTE treatment in cancer patients. The values total patient-years. Moreover, the non-inferiority margins set for the Thrombosis and Haemostasis Vol. Caravaggio study are of the same order of magnitude to those Meier over-estimates the cumulative incidence of VTE. The safety dataset test to assess differences between two study groups when as-treated will consist of all treated subjects randomized competing risks are present.

Comparisons between treat- complete the study fully compliant with the protocol and ment groups in the CATCH study accounted for deaths not without any major violation or deviation. The evaluation of the primary objective The study is performed in accordance with the provisions of will be done by considering the time from randomization to the Declaration of Helsinki and local regulations.

The study to recurrence is limited when death is considered a censored was designed by the Steering Committee members. The event. As the analyses of all the study data.

All the members of the Steering risk of VTE recurrent is zero in a dead patient, by ignoring the Committee have access to the study data, vouch for their effect of death as a competitive risk, the method of Kaplan— accuracy and completeness; they will contribute to the Thrombosis and Haemostasis Vol.

The writing committee, composed by members of the Steering Committee, will write the manuscript and Adverse Event Reporting vouch for the accuracy and completeness of the reported data. The Central the electronic case report from.

Adjudication Committee is composed of medical specialists AEs are described using the Medical Dictionary for Reg- This document was downloaded for personal use only. A DSMB charter was provided to the board members before the start of the study.

The DSMB is com- Several trials aimed at improving the anticoagulant treat- posed of three expert clinicians with experience in the ment in patients with cancer-associated VTE by comparing conduction and monitoring of clinical trials. The risk for the occurrence of NCT On the other hand, if an increase in bleeding in these designed to evaluate the treatment satisfaction in patients is not seen, this observation will be of remarkable patients with VTE and cancer treated with rivaroxaban or clinical importance and patients with gastrointestinal cancer dalteparin.

The regimens has remarkable implications. It is possible that, in Caravaggio study has the potential, along with other studies cancer patients who have high risk of early recurrence, this with similar objective and design, to improve the treatment approach may not be as effective as some period of LMWH of VTE in patients with cancer by making VTE management treatment, either because the dose of apixaban is not high This document was downloaded for personal use only.

On the other hand, a more balanced regimen could reduce the An additional potential advantage associated with the oral risk of bleeding seen in Hokusai VTE cancer study.

A time- administration of apixaban, as of other DOAC, could be the course analysis of the thromboembolic and bleeding events improvement of treatment adherence and persistence.

Most patients are disconti- design of further studies and updating current practice nuing LMWH after 2 to 3 months and either continuing with guidelines. Patients with gastrointestinal cancer treatment for VTE, but limited data are currently including the upper gastrointestinal tract are not excluded available with these agents in patients with concomi- from Caravaggio and are expected to account for approxi- tant cancer.

The type of gastrointestinal malignancy, location and stage of cancer What does this paper add? To ensure patient safety, the DSMB received a aban is non-inferior to subcutaneous LMWH dalte- mandate to monitor bleeding and its severity in patients parin for the treatment of newly diagnosed proximal with gastrointestinal cancer. This is the only DOAC regimen which was not asso- management of VTE less cumbersome in patients with ciated with an increase in gastrointestinal bleeding in the cancer by replacing parenteral with oral anticoagulation.

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