Prophylactic platelet transfusion prior to central venous catheter placement in patients with thrombocytopenia: study protocol for a randomised controlled trial

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Abstract

Background

Severe thrombocytopenia should be corrected by prophylactic platelet transfusion prior to central venous catheter (CVC) insertion, according to national and international guidelines. Even though correction is thought to prevent bleeding complications, evidence supporting the routine administration of prophylactic platelets is absent. Furthermore, platelet transfusion bears inherent risk. Since the introduction of ultrasound-guided CVC placement, bleeding complication rates have decreased. The objective of the current trial is, therefore, to demonstrate that omitting prophylactic platelet transfusion prior to CVC placement in severely thrombocytopenic patients is non-inferior compared to prophylactic platelet transfusion.

Methods/design

The PACER trial is an investigator-initiated, national, multicentre, single-blinded, randomised controlled, non-inferior, two-arm trial in haematologic and/or intensive care patients with a platelet count of between 10 and 50 × 10 ⁹/L and an indication for CVC placement. Consecutive patients are randomly assigned to either receive 1 unit of platelet concentrate, or receive no prophylactic platelet transfusion prior to CVC insertion. The primary endpoint is WHO grades 2–4 bleeding. Secondary endpoints are any bleeding complication, costs, length of intensive care and hospital stay and transfusion requirements.

Discussion

This is the first prospective, randomised controlled trial powered to test the hypothesis of whether omitting forgoing platelet transfusion prior to central venous cannulation leads to an equal occurrence of clinical relevant bleeding complications in critically ill and haematologic patients with thrombocytopenia.

Trial registration

Nederlands Trial Registry, ID: NTR5653 ( http://www.trialregister.nl/trialreg/index.asp). Registered on 27 January 2016. Currently recruiting. Randomisation commenced on 23 February 2016.

Electronic supplementary material

The online version of this article (10.1186/s13063-018-2480-3) contains supplementary material, which is available to authorized users.

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Most cited references 41

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Preventing complications of central venous catheterization.

David C. McGee, Michael Gould (2003)

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Ultrasonic locating devices for central venous cannulation: meta-analysis.

Daniel Hind, Neill W Calvert, Richard McWilliams … (2003)

To assess the evidence for the clinical effectiveness of ultrasound guided central venous cannulation. 15 electronic bibliographic databases, covering biomedical, science, social science, health economics, and grey literature. Systematic review and meta-analysis of randomised controlled trials. Populations Patients scheduled for central venous access. INTERVENTION REVIEWED: Guidance using real time two dimensional ultrasonography or Doppler needles and probes compared with the anatomical landmark method of cannulation. Risk of failed catheter placement (primary outcome), risk of complications from placement, risk of failure on first attempt at placement, number of attempts to successful catheterisation, and time (seconds) to successful catheterisation. 18 trials (1646 participants) were identified. Compared with the landmark method, real time two dimensional ultrasound guidance for cannulating the internal jugular vein in adults was associated with a significantly lower failure rate both overall (relative risk 0.14, 95% confidence interval 0.06 to 0.33) and on the first attempt (0.59, 0.39 to 0.88). Limited evidence favoured two dimensional ultrasound guidance for subclavian vein and femoral vein procedures in adults (0.14, 0.04 to 0.57 and 0.29, 0.07 to 1.21, respectively). Three studies in infants confirmed a higher success rate with two dimensional ultrasonography for internal jugular procedures (0.15, 0.03 to 0.64). Doppler guided cannulation of the internal jugular vein in adults was more successful than the landmark method (0.39, 0.17 to 0.92), but the landmark method was more successful for subclavian vein procedures (1.48, 1.03 to 2.14). No significant difference was found between these techniques for cannulation of the internal jugular vein in infants. An indirect comparison of relative risks suggested that two dimensional ultrasonography would be more successful than Doppler guidance for subclavian vein procedures in adults (0.09, 0.02 to 0.38). Evidence supports the use of two dimensional ultrasonography for central venous cannulation.

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Risk of venous thromboembolism associated with peripherally inserted central catheters: a systematic review and meta-analysis.

Vineet Chopra, Sarah Anand, Andy Hickner … (2013)

Peripherally inserted central catheters (PICCs) are associated with an increased risk of venous thromboembolism. However, the size of this risk relative to that associated with other central venous catheters (CVCs) is unknown. We did a systematic review and meta-analysis to compare the risk of venous thromboembolism associated with PICCs versus that associated with other CVCs. We searched several databases, including Medline, Embase, Biosis, Cochrane Central Register of Controlled Trials, Conference Papers Index, and Scopus. Additional studies were identified through hand searches of bibliographies and internet searches, and we contacted study authors to obtain unpublished data. All human studies published in full text, abstract, or poster form were eligible for inclusion. All studies were of adult patients aged at least 18 years who underwent insertion of a PICC. Studies were assessed with the Newcastle-Ottawa risk of bias scale. In studies without a comparison group, the pooled frequency of venous thromboembolism was calculated for patients receiving PICCs. In studies comparing PICCs with other CVCs, summary odds ratios (ORs) were calculated with a random effects meta-analysis. Of the 533 citations identified, 64 studies (12 with a comparison group and 52 without) including 29 503 patients met the eligibility criteria. In the non-comparison studies, the weighted frequency of PICC-related deep vein thrombosis was highest in patients who were critically ill (13·91%, 95% CI 7·68-20·14) and those with cancer (6·67%, 4·69-8·64). Our meta-analysis of 11 studies comparing the risk of deep vein thrombosis related to PICCs with that related to CVCs showed that PICCs were associated with an increased risk of deep vein thrombosis (OR 2·55, 1·54-4·23, p<0·0001) but not pulmonary embolism (no events). With the baseline PICC-related deep vein thrombosis rate of 2·7% and pooled OR of 2·55, the number needed to harm relative to CVCs was 26 (95% CI 13-71). PICCs are associated with a higher risk of deep vein thrombosis than are CVCs, especially in patients who are critically ill or those with a malignancy. The decision to insert PICCs should be guided by weighing of the risk of thrombosis against the benefit provided by these devices. None. Copyright © 2013 Elsevier Ltd. All rights reserved.

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Author and article information

Contributors

Emma K. van de Weerdt:

ORCID: http://orcid.org/0000-0001-9406-976X

+3120-566 6345 , e.k.vandeweerdt@amc.uva.nl

Bart J. Biemond: b.j.biemond@amc.uva.nl

Sacha S. Zeerleder: s.s.zeerleder@amc.uva.nl

Krijn P. van Lienden: k.p.vanlienden@amc.uva.nl

Jan M. Binnekade: j.m.binnekade@amc.uva.nl

Alexander P. J. Vlaar: a.p.vlaar@amc.uva.nl

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 20 February 2018

Publication date PMC-release: 20 February 2018

Publication date Collection: 2018

Volume: 19

Electronic Location Identifier: 127

Affiliations

[1 ]ISNI 0000000404654431, GRID grid.5650.6, Department of Intensive Care Medicine, , Academic Medical Centre, ; Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands

[2 ]ISNI 0000000404654431, GRID grid.5650.6, Laboratory of Experimental Intensive Care and Anaesthesiology (L.E.I.C.A.), Academic Medical Centre, ; Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands

[3 ]ISNI 0000000404654431, GRID grid.5650.6, Department of Radiology, , Academic Medical Centre, ; Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands

[4 ]ISNI 0000000404654431, GRID grid.5650.6, Department of Haematology, , Academic Medical Centre, ; Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands

[5 ]ISNI 0000000404654431, GRID grid.5650.6, G3–228; Department of Intensive Care, , Academic Medical Centre, ; Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands

Author information

Emma K. van de Weerdt http://orcid.org/0000-0001-9406-976X

Article

Publisher ID: 2480

DOI: 10.1186/s13063-018-2480-3

PMC ID: 5819660

PubMed ID: 29463280

SO-VID: 63fe8e03-3a8e-443d-91aa-fec0d4bc0a79

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 27 June 2017

Date accepted : 19 January 2018

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100001826, ZonMw;

Award ID: 843002625

Award Recipient : Alexander P. J. Vlaar

Custom metadata

ScienceOpen disciplines: Medicine

Keywords: central venous catheter,thrombocytopenia,platelet count,bleeding complication

Data availability:

ScienceOpen disciplines: Medicine

Keywords: central venous catheter, thrombocytopenia, platelet count, bleeding complication

Prophylactic platelet transfusion prior to central venous catheter placement in patients with thrombocytopenia: study protocol for a randomised controlled trial

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Trial registration

Electronic supplementary material

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Herbal Medicines Journal (Herb Med J)

Most cited references 41

Preventing complications of central venous catheterization.

Ultrasonic locating devices for central venous cannulation: meta-analysis.

Risk of venous thromboembolism associated with peripherally inserted central catheters: a systematic review and meta-analysis.

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