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Transfusion of Plasma, Platelets, and Red Blood Cells in a 1:1:1 vs a 1:1:2 Ratio and Mortality in Patients with Severe Trauma (PROPPR)

2015 · paper · Clinical trials

A randomized trial comparing transfusion of plasma, platelets and red blood cells in a 1:1:1 ratio versus a 1:1:2 ratio in patients with severe trauma, with mortality as the main outcome. The supplied text does not include the results.

0 findings

None that passed a second check.

12 minor (typos and the like; most checked by the judge only)
Wording "other studies have reported beneficial outcomes across a wider range of blood product ratios or goal-directed approaches.13,14" cites ref 13 ("Early aggressive use of fresh frozen plasma does not improve outcome…") and ref 14 (blood products and postinjury multiple organ failure).
  • p. 4 Introduction, para 1
    other studies have reported beneficial outcomes across a wider range of blood product ratios or goal-directed approaches.13,14
  • p. 13 References 13-14
    Early aggressive use of fresh frozen plasma does not improve outcome

Only the authors can say what is right here.

Judge's note: Page 4 and the reference list on page 13 checked. The titles of refs 13 and 14 describe no benefit or a harm (multiple organ failure), not beneficial outcomes. On page 9-10 the paper cites 13,14 again, this time for concerns about inflammatory complications. The authors should say whether the wording or the citations are what they intended.

Second check: another model agreed

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Wording Methods: critical administration threshold "denotes patients receiving more than 3 U of RBCs within at least 1 hour"; Table 1 footnote i: "Defined as 3 U or greater of RBCs received at least once per 1-hour interval".
  • p. 7 Methods, Outcomes and Other Variables
    denotes patients receiving more than 3 U of RBCs within at least 1 hour
  • p. 23 Table 1 footnote i
    Defined as 3 U or greater of RBCs received at least once per 1-hour interval
  • p. 7 Methods, Outcomes and Other Variables
    receiving more than 3 U of RBCs within at least 1 hour during the first 24 hours

Only the authors can say what is right here.

Judge's note: Both images checked. The same variable is defined as >3 U in Methods (p7) and as ≥3 U in the footnote (p23), and the two cut-points differ at exactly 3 U. I found no statement that reconciles them. The authors need to say which definition produced the 87% figure.

Second check: another model agreed

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Wording Results text: "37% had hemoglobin levels <11 g/dL" and "38.8% had hemoglobin levels <11 g/dL"; Table 1 labels the same counts "No. (%) with ≤11 g/dL" (121 [37.0], 126 [38.8]).
  • p. 8 Results, para 2
    (37% had hemoglobin levels <11 g/dL)
  • p. 22 Table 1, hemoglobin row
    No. (%) with ≤11 g/dL
  • p. 8 Results para 2
    37% had hemoglobin levels <11 g/dL

Only the authors can say what is right here.

Judge's note: The page 8 text image shows '<'; the Table 1 image on page 22 shows '≤'. The percentages match, so the two places describe one quantity with different inequalities.

Second check: another model agreed

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Wording Figure 1 30-d Mortality boxes read "3 Lost to follow-up / 338 Included in mortality analysis" (1:1:1) and "1 Lost to follow-up / 342 Included in mortality analysis" (1:1:2), but Table 3's 30-day columns use n = 335 and n = 341, and the text says 30-day outcomes were obtained on 99.4%.
  • p. 18 Figure 1, 30-d Mortality box, 1:1:1 arm
    338 Included in mortality analysis
  • p. 26 Table 3 header, 30 days
    1:1:1 Group (n = 335)
  • p. 18 Figure 1, 30-d Mortality boxes
    3 Lost to follow-up ... 338 Included in mortality analysis
  • p. 18 Figure 1, 30-d Mortality box, 1:1:2 arm
    1 Lost to follow-up ... 342 Included in mortality analysis

Only the authors can say what is right here.

Judge's note: I checked the Figure 1 image (p18): the 30-d boxes show 3 and 1 lost to follow-up, with 338 and 342 included. Table 3 (p26) has 30-day headers of n = 335 and n = 341, and 75/335 = 22.4% and 89/341 = 26.1% match the text on p8. The Statistical Analysis section (p7) says the 4 patients were censored in the Cox analyses and that an ITT sensitivity analysis covered all 16 outcome combinations. So 'included' is defensible for the Cox and ITT analyses, but not for the primary Mantel-Haenszel percentages. The label is ambiguous rather than plainly wrong, so this goes to the authors as a query.

Second check: another model agreed

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Wording Table 3 lists "Myocardial infarction 1 (0.3)" as a cause of death in the 1:1:1 group (24 h and 30 d), while Table 4 lists "Myocardial infarction 0 0" complications in that group.
  • p. 26 Table 3, Myocardial infarction row
    1 (0.3)
  • p. 28 Table 4, Myocardial infarction row
    Myocardial infarction 0 0 2 2 (0.6)

Judge's note: I checked both table images (p26 and p28). The values are as quoted, and in the 1:1:2 arm the tables agree (2 and 2). The methods (p6) say each death was adjudicated by an external blinded clinician who assigned one or more causes, so the cause-of-death list and the complications list may come from different processes. The paper does not explain the 1:1:1 difference. Either form could be legitimate, so I record it as an observation.

Second check: another model agreed

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Typo Byline gives "Martin A. Schreiber, MS" (p1); the group listing gives "Martin A. Schreiber, MD" (p16).
  • p. 1 Author byline
    Martin A. Schreiber, MS
  • p. 16 Group Information, OHSU site
    Martin A. Schreiber, MD

Judge's note: Both crops checked. The byline shows 'MS' and the OHSU site listing shows 'MD' for the same person, so the degree is inconsistent within the document.

Second check: none (judge only)

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Typo Byline gives "Deborah M. Stein, MD" (p1); the group listing gives "Deborah M. Stein, MD, MPH" (p16).
  • p. 1 Author byline
    Deborah M. Stein, MD
  • p. 16 Group Information, Maryland site
    Deborah M. Stein, MD, MPH

Judge's note: Both crops checked. The credentials differ. A byline that leaves out a degree is less clearly an error than one that gives a wrong degree, so this is filed as a consistency observation.

Second check: none (judge only)

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Typo Massive transfusion is printed as "(defined as =10 U of RBCs within 24 hours)"; Table 1 footnote h says "10 U or greater".
  • p. 5 Methods, Study Population
    (defined as =10 U of RBCs within 24 hours)

Judge's note: The page image shows an equals sign rather than ≥. Table 1 footnote h (p23) defines massive transfusion as 10 U or greater. This is probably a symbol lost in conversion, but it is in the rendered PDF.

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Typo "difference, −4.2% [95% CI, −9.6% to 1.1%)": opens with a square bracket and closes with a parenthesis.
  • p. 8 Results, para 3
    difference, −4.2% [95% CI, −9.6% to 1.1%)

Judge's note: The page 8 image shows the mismatched brackets.

Second check: none (judge only)

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Typo "difference, −3.7% [95% CI, −10.2% to 2.7%)": opens with a square bracket and closes with a parenthesis.
  • p. 8 Results, para 3
    difference, −3.7% [95% CI, −10.2% to 2.7%)

Judge's note: The page 8 image shows the mismatched brackets.

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Typo Reference 1: "US Centers for Disease Control and Preventionl." has a stray 'l'.
  • p. 12 Reference 1
    US Centers for Disease Control and Preventionl.

Judge's note: The page 12 image shows 'Preventionl'.

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Typo Reference 44: "Postinury hemotherapy and hemostasis" should read "Postinjury".
  • p. 14 Reference 44
    Postinury hemotherapy and hemostasis.
  • p. 14 Reference 44
    Postinury hemotherapy and hemostasis

Judge's note: The page 14 image shows 'Postinury'. Refs 14 and 47 spell the word 'postinjury'.

Second check: none (judge only)

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