TY - JOUR
T1 - Platelet Transfusion before CVC Placement in Patients with Thrombocytopenia
AU - van Baarle, Floor L. F.
AU - van de Weerdt, Emma K.
AU - van der Velden, Walter J. F. M.
AU - Ruiterkamp, Roelof A.
AU - Tuinman, Pieter R.
AU - Ypma, Paula F.
AU - van den Bergh, Walter M.
AU - Demandt, Astrid M. P.
AU - Kerver, Emile D.
AU - Jansen, A. J. Gerard
AU - Westerweel, Peter E.
AU - Arbous, Sesmu M.
AU - Determann, Rogier M.
AU - van Mook, Walther N. K. A.
AU - Koeman, Mirelle
AU - Mäkelburg, Anja B. U.
AU - van Lienden, Krijn P.
AU - Binnekade, Jan M.
AU - Biemond, Bart J.
AU - Vlaar, Alexander P. J.
N1 - Funding Information:
This noninferiority trial was conducted on hematology wards and in ICUs at 10 hospitals in the Netherlands (7 academic and 3 general hospitals). The trial was funded by ZonMw, part of the Dutch Research Council. The institutional review board of the Amsterdam University Medical Center at the University of Amsterdam approved the trial , which has been published previously and is available with the full text of this article at NEJM.org. An independent data and safety monitoring board reviewed the trial conduct. The authors vouch for the accuracy and completeness of the data and for the fidelity of the trial to the protocol.
Funding Information:
Supported by ZonMw , part of the Dutch Research Council (project number, 843002625).
Publisher Copyright:
© 2023 Massachusetts Medical Society.
PY - 2023/5/25
Y1 - 2023/5/25
N2 - BACKGROUND: Transfusion guidelines regarding platelet-count thresholds before the placement of a central venous catheter (CVC) offer conflicting recommendations because of a lack of good-quality evidence. The routine use of ultrasound guidance has decreased CVC-related bleeding complications. METHODS: In a multicenter, randomized, controlled, noninferiority trial, we randomly assigned patients with severe thrombocytopenia (platelet count, 10,000 to 50,000 per cubic millimeter) who were being treated on the hematology ward or in the intensive care unit to receive either one unit of prophylactic platelet transfusion or no platelet transfusion before ultrasound-guided CVC placement. The primary outcome was catheter-related bleeding of grade 2 to 4; a key secondary outcome was grade 3 or 4 bleeding. The noninferiority margin was an upper boundary of the 90% confidence interval of 3.5 for the relative risk. RESULTS: We included 373 episodes of CVC placement involving 338 patients in the per-protocol primary analysis. Catheter-related bleeding of grade 2 to 4 occurred in 9 of 188 patients (4.8%) in the transfusion group and in 22 of 185 patients (11.9%) in the no-transfusion group (relative risk, 2.45; 90% confidence interval [CI], 1.27 to 4.70). Catheter-related bleeding of grade 3 or 4 occurred in 4 of 188 patients (2.1%) in the transfusion group and in 9 of 185 patients (4.9%) in the no-transfusion group (relative risk, 2.43; 95% CI, 0.75 to 7.93). A total of 15 adverse events were observed; of these events, 13 (all grade 3 catheter-related bleeding [4 in the transfusion group and 9 in the no-transfusion group]) were categorized as serious. The net savings of withholding prophylactic platelet transfusion before CVC placement was $410 per catheter placement. CONCLUSIONS: The withholding of prophylactic platelet transfusion before CVC placement in patients with a platelet count of 10,000 to 50,000 per cubic millimeter did not meet the predefined margin for noninferiority and resulted in more CVC-related bleeding events than prophylactic platelet transfusion. (Funded by ZonMw; PACER Dutch Trial Register number, NL5534.).
AB - BACKGROUND: Transfusion guidelines regarding platelet-count thresholds before the placement of a central venous catheter (CVC) offer conflicting recommendations because of a lack of good-quality evidence. The routine use of ultrasound guidance has decreased CVC-related bleeding complications. METHODS: In a multicenter, randomized, controlled, noninferiority trial, we randomly assigned patients with severe thrombocytopenia (platelet count, 10,000 to 50,000 per cubic millimeter) who were being treated on the hematology ward or in the intensive care unit to receive either one unit of prophylactic platelet transfusion or no platelet transfusion before ultrasound-guided CVC placement. The primary outcome was catheter-related bleeding of grade 2 to 4; a key secondary outcome was grade 3 or 4 bleeding. The noninferiority margin was an upper boundary of the 90% confidence interval of 3.5 for the relative risk. RESULTS: We included 373 episodes of CVC placement involving 338 patients in the per-protocol primary analysis. Catheter-related bleeding of grade 2 to 4 occurred in 9 of 188 patients (4.8%) in the transfusion group and in 22 of 185 patients (11.9%) in the no-transfusion group (relative risk, 2.45; 90% confidence interval [CI], 1.27 to 4.70). Catheter-related bleeding of grade 3 or 4 occurred in 4 of 188 patients (2.1%) in the transfusion group and in 9 of 185 patients (4.9%) in the no-transfusion group (relative risk, 2.43; 95% CI, 0.75 to 7.93). A total of 15 adverse events were observed; of these events, 13 (all grade 3 catheter-related bleeding [4 in the transfusion group and 9 in the no-transfusion group]) were categorized as serious. The net savings of withholding prophylactic platelet transfusion before CVC placement was $410 per catheter placement. CONCLUSIONS: The withholding of prophylactic platelet transfusion before CVC placement in patients with a platelet count of 10,000 to 50,000 per cubic millimeter did not meet the predefined margin for noninferiority and resulted in more CVC-related bleeding events than prophylactic platelet transfusion. (Funded by ZonMw; PACER Dutch Trial Register number, NL5534.).
UR - https://www.scopus.com/pages/publications/85160160217
U2 - 10.1056/NEJMoa2214322
DO - 10.1056/NEJMoa2214322
M3 - Article
C2 - 37224197
SN - 0028-4793
VL - 388
SP - 1956
EP - 1965
JO - The New England journal of medicine
JF - The New England journal of medicine
IS - 21
ER -