Evidence map›Paper›PMID 42275536›Full record

Observational studyBlood advances2026

Effect of PCC on thrombin generation in patients on FXaI with bleeding or needing urgent surgery (GAUGE).

Joseph R Shaw, Hannah Gray, Yan Xu, Grégoire Le Gal, Tzu-Fei Wang, Roy Khalife, Deborah M Siegal, Lana A Castellucci, Aurélien Delluc, Matthieu Grussé and 6 more

Abstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Blood advances, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Advances in targeted and cellular therapies for relapsed/refractory mantle cell lymphoma: immunotherapeutic strategies and challenges.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Joseph R ShawDepartment of Medicine, University of Ottawa, Ottawa, ON, Canada.ORCID 0000-0002-2405-7912
Hannah GrayDepartment of Medicine, University of Ottawa, Ottawa, ON, Canada.
Yan XuDepartment of Medicine, University of Ottawa, Ottawa, ON, Canada.ORCID 0000-0001-7429-4724
Grégoire Le GalDepartment of Medicine, University of Ottawa, Ottawa, ON, Canada.
Tzu-Fei WangDepartment of Medicine, University of Ottawa, Ottawa, ON, Canada.ORCID 0000-0003-2407-9000
Roy KhalifeDepartment of Medicine, University of Ottawa, Ottawa, ON, Canada.ORCID 0000-0002-3401-4086
Deborah M SiegalDepartment of Medicine, University of Ottawa, Ottawa, ON, Canada.ORCID 0000-0003-3806-3245
Lana A CastellucciDepartment of Medicine, University of Ottawa, Ottawa, ON, Canada.ORCID 0000-0003-1322-9368
Aurélien DellucDepartment of Medicine, University of Ottawa, Ottawa, ON, Canada.ORCID 0000-0003-0227-1245
Matthieu GrusséDiagnostica Stago, Gennevilliers, Paris, France.
Patrick Van DredenDiagnostica Stago, Gennevilliers, Paris, France.
Dar DowlatshahiDepartment of Medicine, University of Ottawa, Ottawa, ON, Canada.
Katryna PetersenDivision of Hematology and Transfusion Medicine, Department of Pathology and Laboratory Medicine, The Ottawa Hospital, Ottawa, ON, Canada.
Hakan BuyukdereDivision of Hematology and Transfusion Medicine, Department of Pathology and Laboratory Medicine, The Ottawa Hospital, Ottawa, ON, Canada.
Timothy RamsayDepartment of Medicine, University of Ottawa, Ottawa, ON, Canada.
Marc CarrierDepartment of Medicine, University of Ottawa, Ottawa, ON, Canada.ORCID 0000-0001-8296-2972

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

abstractProthrombin complex concentrates (PCC) are used off-label to treat direct factor Xa inhibitor (FXaI)-associated bleeding or to optimize hemostasis before urgent surgery. The Global Assessment of Hemostatic TGA Indices Following the Use of Prothrombin Complex Concentrates for Major Bleeding or Urgent Surgery in Patients Treated with Factor Xa Inhibitors (GAUGE) study is a prospective observational cohort study of the effects of PCC on thrombin generation and hemostasis in FXaI-treated patients. FXaI-treated patients who presented with major bleeding or needed urgent surgery received PCC (50 IU/kg). Platelet-poor plasma was collected before and after PCC administration. Thrombin generation assay parameters, including lag time (LT), time to peak (TTP), peak thrombin generation (peak), endogenous thrombin potential (ETP), and mean velocity rate index (mVRI) were measured using calibrated automated thrombography. Hemostatic efficacy, thromboembolism, and mortality were adjudicated in duplicate. Multivariable log-linear regression was used to evaluate PCC effects on FXaI levels. Unsupervised k-means clustering was used to identify patients with the largest ETP increment. GAUGE included 101 episodes of FXaI-associated PCC use (FXaI-associated bleeding = 71; urgent surgery = 30). The median PCC dose was 48.0 IU/kg (interquartile range [IQR], 42.0-50.0). PCC did not affect FXaI levels (P> .05). PCC increased ETP (Δ868.9 ± 766.6 nM/min), peak (Δ85.7nM ± 108.2nM), and mVRI (Δ16.5 nM/min [IQR, 4.4-45.0]). PCC did not affect the LT or TTP (P> .05). Patients in cluster 1 had significantly lower pre-PCC FXaI levels (79 ng/mL [IQR, 55-93] vs 165 ng/mL [IQR, 77-219]; P = .009) and a greater ΔETP increment (P< .0001) than patients in cluster 2. Effective hemostasis was achieved in 50.0% of major bleeding events (95% confidence interval [CI], 38.4-61.6), and procedural hemostasis was normal in 76.7% of urgent surgeries (95% CI, 59.1-88.2). The 30-day risks of thromboembolism and mortality were 6.9% (95% CI, 3.4-13.6) and 12.9% (95% CI, 7.7-20.8), respectively. PCC increased quantitative thrombin generation without shortening LT or TTP, supporting a prohemostatic effect rather than true FXaI reversal.

Indexed as

Blood Coagulation FactorsFactor Xa InhibitorsHemorrhageThrombinAgedFemaleHemostasisHumansMaleMiddle AgedProspective StudiesBlood Coagulation FactorsFactor Xa Inhibitorsprothrombin complex concentratesThrombin

Identifiers

PMID42275536
PMCPMC13452292

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.