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Reporting of attrition/exclusions insufficient to permit judgement: no information on number of catheters losing patency in each group Not blinded, but the outcome is categorical (blood aspiration possible or not) and is not likely to be influenced by lack of blinding Source of support: partially funded by Leuvens Kankerinstituut and by B Braun BelgiumĪllocation concealment by means of sequentially numbered participant cards, stored in a separate room Main unit of randomisation was the number of catheters accessed, but Goosens provided additional information about occlusions per participant Use of heparin IV was an exclusion criterion Secondary outcomes: catheter‐related bacteraemia within 180 days, duration of catheterįollowing contact with trialists, we obtained additional raw data, which we used in the analysis inability to aspirate blood while injection is easy) Primary outcome: withdrawal occlusion at access (i.e. Not enough information to permit judgement of other biasĨ02 participants older than 1 year with an onco‐haematological malignancy, from Belgiumġ0 mL 0.9% NaCl and after 3 mL heparin (100 IU/mL) All outcomes reported in the protocol were stated in the paper Open‐label, but outcome measurement not likely to be influenced by lack of blindingĥ% of withdrawals in 0.9% NaCl group and 2.5% in heparin group with no details providedĮudract_number: 2009‐013620‐22. Therefore allocation sequence was concealed The goal of the procedure was to ensure that the clinician was not informed a priori if patient had been assigned to normal saline group or heparin group. Quote: "A random allocation sequence was created using a computerized procedure on‐line"Īllocation was determined after the nurse/doctor entered some patient and device data into the web page of the study. Source of support: Fondo Edo Tempia of Biella Median follow‐up was 231.8 days in the saline group and 251.8 day in the heparin group Patients with implanted TIVAD requiring TPN during the course of the study were kept off the study because of increased risk of occlusion due to TPN. Patients with leukaemia or known intolerance to heparin were excluded, as were those whose device had some complications after insertion or who were planning to start parenteral nutrition with lipid. Secondary outcomes: catheter‐related infections, thrombosis, extravasation
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Main outcome: port failure for lumen occlusion Multi‐centre open‐label RCT conducted in 14 Italian oncology clinicsĤ30 adult patients with cancer with a new TIVAD from Italyĥ mL (50 IU) of normal saline via positive‐pressure technique vs "heparin" (the device was flushed as in the normal saline group, then was locked with 5 mL of heparin solution (50 UI/mL) using positive‐pressure technique)
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Study appears to be free of other sources of bias Study protocol is not available, but it is clear that published reports include all expected outcomes, including those that were prespecified
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Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups No blinding of outcome assessment but outcome measurement not likely to be influenced by lack of blinding Open‐label trial, but the outcome is not likely to be influenced by lack of blinding Method of concealment not described or not described in sufficient detail to allow a definitive judgement Information insufficient to permit judgement. Quote: "A random block design with concealment was used" No data on use of systemic anticoagulation, as stated by study authors Occlusion of PICCs, average duration of use of catheter (in days)įollow‐up until the first of the following: event (occlusion) or discharge We sent a letter to study authors regarding the protocol, but we received no responseġ02 participants with single‐lumen PICCs with luer‐activated devices, from USA Three participants in the heparin group and 1 in the 0.9% NaCl group withdrew Not blinded to outcomes but outcome measurement not likely to be influenced by lack of blinding Random sequence generation (selection bias)īlinding of participants and personnel (performance bias)īlinding of outcome assessment (detection bias) Source of support: Isfahan University of Medical Sciences Manoeuvre needed to maintain catheter patency catheter thrombosis bleeding PTT Locking with heparin (1000 IU) vs with 0.9% saline 100 adult patients from Iran with chronic kidney disease