PACER
Trial question
Is withholding prophylactic platelet transfusion noninferior to prophylactic platelet transfusion before central venous catheter placement in patients with thrombocytopenia?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 373
373 patients (133 female, 240 male).
Inclusion criteria: patients with severe thrombocytopenia who were being treated in the hematology ward or in the ICU.
Key exclusion criteria: use of a therapeutically administered anticoagulant; congenital, acquired coagulation factor deficiency, bleeding risk or a spontaneously prolonged INR ≥ 1.5.
Interventions
N=185 no transfusion (no platelet transfusion before central venous catheter placement).
N=188 transfusion (one unit of platelet concentrate transfusion before central venous catheter placement).
Primary outcome
Grade 2-4 catheter-related bleeding within 24 hours after central venous catheter placement
11.9%
4.8%
11.9 %
8.9 %
6.0 %
3.0 %
0.0 %
No
transfusion
Transfusion
Difference exceeding
non-inferiority
margin ✗
Difference exceeding non-inferiority margin in grade 2-4 catheter-related bleeding within 24 hours after central venous catheter placement (11.9% vs. 4.8%; RR 2.45, 90% CI 1.27 to 4.7).
Secondary outcomes
No significant difference in grade 3-4 catheter-related bleeding (4.9% vs. 2.1%; RR 2.43, 95% CI 0.75 to 7.93).
No significant difference in hematoma (18.9% vs. 12.2%; RR 1.62, 95% CI 0.94 to 2.8).
No significant difference in rate of red-cell transfusion in ≤ 24 hours (0.49 vs. 0.48; RR 1.02, 95% CI 0.76 to 1.37).
Conclusion
In patients with severe thrombocytopenia who were being treated in the hematology ward or in the ICU, no transfusion was not noninferior to transfusion with respect to grade 2-4 catheter-related bleeding within 24 hours after central venous catheter placement.
Reference
Floor L F van Baarle, Emma K van de Weerdt, Walter J F M van der Velden et al. Platelet Transfusion before CVC Placement in Patients with Thrombocytopenia. N Engl J Med. 2023 May 25;388(21):1956-1965.
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