Transfusing neonates based on platelet count vs. platelet mass: A randomized feasibility-pilot study

J, Zisk; Mackley, Amy; Clearly, Gerrard; Chang, Eddie L.; Christensen, Robert D.; Paul, David A.

doi:10.3109/09537104.2013.843072

Cited by 22 publications

(20 citation statements)

References 18 publications

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“…We cannot rule out the possibility that during acute thrombocytopenia changes in MPV may be more acute. Because platelet counts were not confirmed by manual count, we cannot exclude the unlikely possibility that some infants may have had pseudothrombocytopenia [82]. ”…”

Section: Discussionmentioning

confidence: 99%

“…An alternative study design for platelet transfusion study may involve enrolling a larger number of infants on admission, regardless of platelet count, with transfusion guidelines to apply only if they actually become thrombocytopenic. This approach may limit the stress on families of being approached about the need for transfusion and a transfusion related study simultaneously [82]. ”…”

Section: Discussionmentioning

confidence: 99%

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CONSORT 2010 statement: extension to randomised pilot and feasibility trials

Eldridge

Chan

Campbell

et al. 2016

Pilot Feasibility Stud

1,621

1,115

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The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply.The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist.The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number.This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials.Editor’s note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites.Electronic supplementary materialThe online version of this article (doi:10.1186/s40814-016-0105-8) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

Eldridge

Chan

Campbell

et al. 2016

Pilot Feasibility Stud

1,621

1,115

View full text Add to dashboard Cite

show abstract

“…A pilot randomized trial conducted in 30 infants concluded that such a study would be feasible, although it would likely require a very large sample size. 41 …”

Section: Current Recommendationsmentioning

confidence: 99%

Platelet Transfusions in the Neonatal Intensive Care Unit

Sparger

Deschmann

Sola‐Visner

2015

Clinics in Perinatology

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“…This approach has not been tested in a traditional prospective randomized trial where neonates are transfused using one or the other guideline, and where caregivers are masked to the guideline used. However, Zisk et al [60] showed the feasibility of this approach in a pilot randomized trial, concluding that a randomized trial would likely require perhaps 100 or more patients per group. We judge that the recommendation to use platelet mass in the transfusion decision is derived from category of evidence 2B and the strength of recommendation is graded moderate/small C (table 6).…”

Section: Prophylactic Platelet Transfusionsmentioning

confidence: 99%

Evidence-Based Advances in Transfusion Practice in Neonatal Intensive Care Units

2014

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Background: Transfusions to neonates convey both benefits and risks, and evidence is needed to guide wise use. Such evidence is accumulating, but more information is needed to generate sound evidence-based practices. Objective: We sought to analyze published information on nine aspects of transfusion practice in neonatal intensive care units. Methods: We assigned ‘categories of evidence' and ‘recommendations' using the format of the United States Preventive Services Task Force of the Agency for Healthcare Research and Quality. Results: The nine practices studied were: (1) delayed clamping or milking of the umbilical cord at preterm delivery - recommended, high/substantial A; (2) drawing the initial blood tests from cord/placental blood from very low birth weight (VLBW, <1,500 g) infants at delivery - recommended, moderate/moderate B; (3) limiting phlebotomy losses of VLBW infants - recommended, moderate/substantial B; (4) selected use of erythropoiesis-stimulating agents to prevent transfusions - recommended, moderate/moderate-moderate/small B, C; (5) using platelet mass, rather than platelet count, in platelet transfusion decisions - recommended, moderate/small C; (6) permitting the platelet count to fall to <20,000/µl in ‘stable' neonates before transfusing platelets - recommended, low/small I; (8) permitting the platelet count to fall to <50,000/µl in ‘unstable' neonates before transfusing platelets - recommended, moderate/small C, and (9) not performing routine coagulation test screening on every VLBW infant - recommended, moderate/small C. Conclusions: We view these recommendations as dynamic, to be revised as additional evidence becomes available. We predict this list will expand as new studies provide more information to guide best transfusion practices.

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Transfusing neonates based on platelet count vs. platelet mass: A randomized feasibility-pilot study

Cited by 22 publications

References 18 publications

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

Platelet Transfusions in the Neonatal Intensive Care Unit

Evidence-Based Advances in Transfusion Practice in Neonatal Intensive Care Units

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