Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

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

Authors: Emma K. van de Weerdt, Bart J. Biemond, Sacha S. Zeerleder, Krijn P. van Lienden, Jan M. Binnekade, Alexander P. J. Vlaar, Study collaborative

Published in: Trials | Issue 1/2018

Login to get access

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 × 109/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.
Appendix
Available only for authorised users
Literature
1.
2.
Graham AS, Ozment C, Tegtmeyer K, Lai S, Braner DA. Central venous catheterization. N Engl J Med. 2007;356:e21.CrossRefPubMed
3.
Strauss R, Wehler M, Mehler K, Kreutzer D, Koebnick C, Hahn EG. Thrombocytopenia in patients in the medical intensive care unit: bleeding prevalence, transfusion requirements, and outcome*. Crit Care Med. 2002;30:1765–71.CrossRefPubMed
4.
Vanderschueren S, De Weerdt A, Malbrain M, Vankersschaever D, Frans E, Wilmer A, Bobbaers H. Thrombocytopenia and prognosis in intensive care. Crit Care Med. 2000;28:1871–6.CrossRefPubMed
5.
Sensebé L, Giraudeau B, Bardiaux L, Deconinck E, Schmidt A, Bidet M-L, LeNiger C, Hardy E, Babault C, Senecal D. The efficiency of transfusing high doses of platelets in hematologic patients with thrombocytopenia: results of a prospective, randomized, open, blinded end point (PROBE) study. Blood. 2005;105:862–4.CrossRefPubMed
6.
Chee YL, Crawford JC, Watson HG, Greaves M. Guidelines on the assessment of bleeding risk prior to surgery or invasive procedures. British Committee for Standards in Haematology. Br J Haematol. 2008;140:496–504.CrossRefPubMed
7.
Steib A, Freys G, Lehmann C, Meyer C, Mahoudeau G. Intraoperative blood losses and transfusion requirements during adult liver transplantation remain difficult to predict. Can J Anaesth. 2001;48:1075–9.CrossRefPubMed
8.
Muller MC, Arbous MS, Spoelstra-de Man AM, Vink R, Karakus A, Straat M, Binnekade JM, de Jonge E, Vroom MB, Juffermans NP. Transfusion of fresh-frozen plasma in critically ill patients with a coagulopathy before invasive procedures: a randomized clinical trial (CME). Transfusion. 2015;55:26–35. quiz 25CrossRefPubMed
9.
Segal JB, Dzik WH. Transfusion Medicine/Hemostasis Clinical Trials Network. Paucity of studies to support that abnormal coagulation test results predict bleeding in the setting of invasive procedures: an evidence-based review. Transfusion. 2005;45:1413–25.CrossRefPubMed
10.
11.
12.
Kaufman RM, Djulbegovic B, Gernsheimer T, Kleinman S, Tinmouth AT, Capocelli KE, Cipolle MD, Cohn CS, Fung MK, Grossman BJ. Platelet transfusion: a clinical practice guideline from the AABB. Ann Intern Med. 2015;162:205–13.CrossRefPubMed
13.
Estcourt LJ, Birchall J, Allard S, Bassey SJ, Hersey P, Kerr JP, Mumford AD, Stanworth SJ, Tinegate H. Guidelines for the use of platelet transfusions. Br J Haematol. 2017;176:365–94.CrossRefPubMed
14.
van de Weerdt EK, Peters AL, Goudswaard EJ, Binnekade JM, van Lienden KP, Biemond BJ, Vlaar APJ. The practice of platelet transfusion prior to central venous catheterization in presence of coagulopathy: a national survey among clinicians. Vox Sang. 2017;112:343–51.CrossRefPubMed
15.
Vlaar AP, Juffermans NP. Transfusion-related acute lung injury: a clinical review. Lancet. 2013;382:984–94.CrossRefPubMed
16.
Yazer MH, Triulzi DJ, Shaz B, Kraus T, Zimring JC. Does a febrile reaction to platelets predispose recipients to red blood cell alloimmunization? Transfusion. 2009;49:1070–5.CrossRefPubMed
17.
Savage WJ, Tobian AA, Savage JH, Hamilton RG, Ness PM. Atopic predisposition of recipients in allergic transfusion reactions to apheresis platelets. Transfusion. 2011;51:2337–42.CrossRefPubMedPubMedCentral
18.
Centers for Disease Control and Prevention. Fatal bacterial infections associated with platelet transfusions—United States, 2004. MMWR Morb Mortal Wkly Rep. 2005;54:168–70.
19.
Vassallo RR. Recognition and management of antibodies to human platelet antigens in platelet transfusion-refractory patients. Immunohematology. 2009;25:119–24.PubMed
20.
Vamvakas EC, Blajchman MA. Transfusion-related mortality: the ongoing risks of allogeneic blood transfusion and the available strategies for their prevention. Blood. 2009;113:3406–17.CrossRefPubMed
21.
Foroutan-Rad M, Majidiani H, Dalvand S, Daryani A, Kooti W, Saki J, Hedayati-Rad F, Ahmadpour E. Toxoplasmosis in blood donors: a systematic review and meta-analysis. Transfus Med Rev. 2016;30(3):116–22.CrossRefPubMed
22.
Li G, Rachmale S, Kojicic M, Shahjehan K, Malinchoc M, Kor DJ, Gajic O. Incidence and transfusion risk factors for transfusion-associated circulatory overload among medical intensive care unit patients. Transfusion. 2011;51:338–43.CrossRefPubMed
23.
De Korte D, Curvers J, De Kort WL, Hoekstra T, Van Der Poel CL, Beckers EA, Marcelis JH. Effects of skin disinfection method, deviation bag, and bacterial screening on clinical safety of platelet transfusions in the Netherlands. Transfusion. 2006;46:476–85.CrossRefPubMed
24.
Engele LJ, Straat M, van Rooijen IHM, de Vooght KMK, Cremer OL, Schultz MJ, Bos LDJ, Juffermans NP, Consortium M. Transfusion of platelets, but not of red blood cells, is independently associated with nosocomial infections in the critically ill. Ann Intensive Care. 2016;6:67.CrossRefPubMedPubMedCentral
25.
Silliman CC, Boshkov LK, Mehdizadehkashi Z, Elzi DJ, Dickey WO, Podlosky L, Clarke G, Ambruso DR. Transfusion-related acute lung injury: epidemiology and a prospective analysis of etiologic factors. Blood. 2003;101:454–62.CrossRefPubMed
26.
Foster PF, Moore LR, Sankary HN, Hart ME, Ashmann MK, Williams JW. Central venous catheterization in patients with coagulopathy. Arch Surg. 1992;127:273–5.CrossRefPubMed
27.
Napolitano M, Malato A, Raffaele F, Palazzolo M, Lo Iacono G, Pinna R, Geraci G, Modica G, Saccullo G, Siragusa S. Ultrasonography-guided central venous catheterisation in haematological patients with severe thrombocytopenia. Blood Transfus. 2013;11:506–9.PubMedPubMedCentral
28.
Zeidler K, Arn K, Senn O, Schanz U, Stussi G. Optimal preprocedural platelet transfusion threshold for central venous catheter insertions in patients with thrombocytopenia. Transfusion. 2011;51:2269–76.CrossRefPubMed
29.
Hind D, Calvert N, McWilliams R, Davidson A, Paisley S, Beverley C, Thomas S. Ultrasonic locating devices for central venous cannulation: meta-analysis. BMJ. 2003;327:361.CrossRefPubMedPubMedCentral
30.
Fragou M, Gravvanis A, Dimitriou V, Papalois A, Kouraklis G, Karabinis A, Saranteas T, Poularas J, Papanikolaou J, Davlouros P, et al. Real-time ultrasound-guided subclavian vein cannulation versus the landmark method in critical care patients: a prospective randomized study. Crit Care Med. 2011;39:1607–12.CrossRefPubMed
31.
Wu S-y, Ling Q, Cao L-H, Wang J, Xu M-X, Zeng W-A. Real-time two-dimensional ultrasound guidance for central venous cannulation: a meta-analysis. J Am Soc Anesthesiol. 2013;118:361–75.CrossRef
32.
Singh SA, Sharma S, Singh A, Singh AK, Sharma U, Bhadoria AS. The safety of ultrasound guided central venous cannulation in patients with liver disease. Saudi J Anaesth. 2015;9:155–60.CrossRefPubMedPubMedCentral
33.
Vinson DR, Ballard DW, Hance LG, Hung Y, Rauchwerger AS, Reed ME, Kene MV, Chettipally UK, Elms AR, Mark DG. Bleeding complications of central venous catheterization in septic patients with abnormal hemostasis. Am J Emerg Med. 2014;32:737–42.CrossRefPubMed
34.
World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310:2191–4.CrossRef
35.
Bishop L, Dougherty L, Bodenham A, Mansi J, Crowe P, Kibbler C, Shannon M, Treleaven J. Guidelines on the insertion and management of central venous access devices in adults. Int J Lab Hematol. 2007;29:261–78.CrossRefPubMed
36.
Jansen T, Kompanje E, Druml C, Menon D, Wiedermann C, Bakker J. Deferred consent in emergency intensive care research: what if the patient dies early? Use the data or not? Intensive Care Med. 2007;33:894–900.CrossRefPubMedPubMedCentral
37.
Polderman KH, Girbes AJ. Central venous catheter use. Part 1: mechanical complications. Intensive Care Med. 2002;28:1–17.CrossRefPubMed
38.
Moureau N, Lamperti M, Kelly LJ, Dawson R, Elbarbary M, van Boxtel AJ, Pittiruti M. Evidence-based consensus on the insertion of central venous access devices: definition of minimal requirements for training. Br J Anaesth. 2013;110:347–56.CrossRefPubMed
39.
Slichter SJ, Kaufman RM, Assmann SF, McCullough J, Triulzi DJ, Strauss RG, Gernsheimer TB, Ness PM, Brecher ME, Josephson CD. Dose of prophylactic platelet transfusions and prevention of hemorrhage. N Engl J Med. 2010;362:600–13.CrossRefPubMedPubMedCentral
40.
Arnold DM, Donahoe L, Clarke FJ, Tkaczyk AJ, Heels-Ansdell D, Zytaruk N, Cook R, Webert KE, McDonald E, Cook DJ. Bleeding during critical illness: a prospective cohort study using a new measurement tool. Clin Invest Med. 2007;30:E93–102.CrossRefPubMed
41.
Oguzkurt L, Tercan F, Kara G, Torun D, Kizilkilic O, Yildirim T. US-guided placement of temporary internal jugular vein catheters: immediate technical success and complications in normal and high-risk patients. Eur J Radiol. 2005;55:125–9.CrossRefPubMed
42.
Fisher N, Mutimer D. Central venous cannulation in patients with liver disease and coagulopathy—a prospective audit. Intensive Care Med. 1999;25:481–5.CrossRefPubMed
43.
Haas B, Chittams JL, Trerotola SO. Large-bore tunneled central venous catheter insertion in patients with coagulopathy. J Vasc Interv Radiol. 2010;21:212–7.CrossRefPubMed
44.
45.
Ruesch S, Walder B, Tramer MR. Complications of central venous catheters: internal jugular versus subclavian access—a systematic review. Crit Care Med. 2002;30:454–60.CrossRefPubMed
46.
McGee DC, Gould MK. Preventing complications of central venous catheterization. N Engl J Med. 2003;348:1123–33.CrossRefPubMed
47.
Chopra V, Anand S, Hickner A, Buist M, Rogers MA, Saint S, Flanders SA. Risk of venous thromboembolism associated with peripherally inserted central catheters: a systematic review and meta-analysis. Lancet. 2013;382:311–25.CrossRefPubMed
48.
Gualtieri E, Deppe SA, Sipperly ME, Thompson DR. Subclavian venous catheterization: greater success rate for less experienced operators using ultrasound guidance. Crit Care Med. 1995;23:692–7.CrossRefPubMed
49.
Sznajder JI, Zveibil FR, Bitterman H, Weiner P, Bursztein S. Central vein catheterization. Failure and complication rates by three percutaneous approaches. Arch Intern Med. 1986;146:259–61.CrossRefPubMed
50.
Mey U, Glasmacher A, Hahn C, Gorschluter M, Ziske C, Mergelsberg M, Sauerbruch T, Schmidt-Wolf IG. Evaluation of an ultrasound-guided technique for central venous access via the internal jugular vein in 493 patients. Support Care Cancer. 2003;11:148–55.PubMed
51.
Mumtaz H, Williams V, Hauer-Jensen M, Rowe M, Henry-Tillman RS, Heaton K, Mancino AT, Muldoon RL, Klimberg VS, Broadwater JR. Central venous catheter placement in patients with disorders of hemostasis. Am J Surg. 2000;180:503–6.CrossRefPubMed
Metadata
Title
Prophylactic platelet transfusion prior to central venous catheter placement in patients with thrombocytopenia: study protocol for a randomised controlled trial
Authors
Emma K. van de Weerdt
Bart J. Biemond
Sacha S. Zeerleder
Krijn P. van Lienden
Jan M. Binnekade
Alexander P. J. Vlaar
Study collaborative
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2480-3

Other articles of this Issue 1/2018

Trials 1/2018 Go to the issue

Commentary

Multiple-level stakeholder engagement in malaria clinical trials: addressing the challenges of conducting clinical research in resource-limited settings

Study protocol

Controlled Education of patients after Stroke (CEOPS)- nurse-led multimodal and long-term interventional program involving a patient’s caregiver to optimize secondary prevention of stroke: study protocol for a randomized controlled trial

Study protocol

Mindfulness as a complementary intervention in the treatment of overweight and obesity in primary health care: study protocol for a randomised controlled trial

Research

Description of complex interventions: analysis of changes in reporting in randomised trials since 2002

Study protocol

The impact of manual rotation of the occiput posterior position on spontaneous vaginal delivery rate: study protocol for a randomized clinical trial (RMOS)

Study protocol

Erythropoietin as an add-on treatment for cognitive side effects of electroconvulsive therapy: a study protocol for a randomized controlled trial