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<p>Rotational thromboelastometry (ROTEM) offers rapid, point-of-care assessment of hemostasis and is increasingly used in massive bleeding [1,2]. However, its high capital and reagent costs limit widespread adoption in low- and middle-income countries like India. This study evaluated the diagnostic performance and turnaround time (TAT) of ROTEM compared with conventional coagulation tests (CCT) and explored the feasibility and cost implications of replacing or supplementing CCT with ROTEM in massive bleeding. In this exploratory cross-sectional study, ROTEM assays (EXTEM, INTEM, FIBTEM) were performed in adult patients in parallel with PT, aPTT, fibrinogen, and platelet count. Correlation and diagnostic performance were assessed using Pearson correlation and ROC analysis. TAT for ROTEM and CCT was compared. Contextual cost and feasibility analysis used locally available device and reagent price ranges and published economic evaluations of viscoelastic hemostatic assays. A total of 109 patients were included. Trauma was the most common indication. Mean TAT for ROTEM was significantly lower than CCT (11.2 ± 2.4 v/s 33.5 ± 5&#xa0;min). FIBTEM parameters A5, A10 and MCF correlated excellently with fibrinogen (r values of 0.858, 0.856,0.855) while EXTEM A5, A10 and MCF correlated strongly with platelet counts (r values of 0.558,0.554, 0.528). In contrast, PT showed only moderate correlations with CT and CFT of EXTEM (<i>r</i> = 0.472, 0.403), and so is APTT with CT and CFT of INTEM (<i>r</i> = 0.452, 0.377). EXTEM versus fibrinogen ROC curve AUC for A5, A10, and MCF EXTEM were 0.812, 0.813 and 0.810 with cut-offs around 35–56.5&#xa0;mm, yielding sensitivities and specificities in the 70–74% range. For FIBTEM versus fibrinogen AUC for A5, A10, and MCF, FIBTEM were excellent, 0.955, 0.952 and 0.947, with cut-offs of 9.5, 11.5, and 11.5&#xa0;mm providing sensitivities and specificities &gt; 80%. In the Indian context, ROTEM device acquisition costs are higher, but published models suggest viscoelastic-guided algorithms can be cost-saving in high-volume trauma and cardiac settings by reducing blood product use and transfusion-related complications. In this single-centre exploratory study, ROTEM provides faster and better global assessment of clot generation, firmness and stability than CCT and strongly identifies and differentiates fibrinogen and platelet-related defects. However, its high capital and running costs limit its feasibility as a complete replacement for CCT in India. A pragmatic, cost-conscious model is the selective deployment of ROTEM in tertiary trauma, transplant, and high-risk obstetric centres, using FIBTEM and EXTEM parameters to guide targeted intervention in bleeding management while retaining CCT for broader use and pathway-specific diagnostics.</p>

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Thromboelastometry as a Substitute for Conventional Coagulation Tests in Massive Bleeding? A Comparative Study with Feasibility and Cost Considerations from South India

  • 期刊论文

  • 发表日期：

    2026年5月8日

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  • V. J. Arun,
  • Ramesh Bhaskaran,
  • Aboobacker Mohamed Rafi,
  • Susheela J. Innah,
  • U. B. Davood,
  • Aswin K. Mohan,
  • Nithya M. Baiju,
  • V. Sree Raj

摘要

Rotational thromboelastometry (ROTEM) offers rapid, point-of-care assessment of hemostasis and is increasingly used in massive bleeding [1,2]. However, its high capital and reagent costs limit widespread adoption in low- and middle-income countries like India. This study evaluated the diagnostic performance and turnaround time (TAT) of ROTEM compared with conventional coagulation tests (CCT) and explored the feasibility and cost implications of replacing or supplementing CCT with ROTEM in massive bleeding. In this exploratory cross-sectional study, ROTEM assays (EXTEM, INTEM, FIBTEM) were performed in adult patients in parallel with PT, aPTT, fibrinogen, and platelet count. Correlation and diagnostic performance were assessed using Pearson correlation and ROC analysis. TAT for ROTEM and CCT was compared. Contextual cost and feasibility analysis used locally available device and reagent price ranges and published economic evaluations of viscoelastic hemostatic assays. A total of 109 patients were included. Trauma was the most common indication. Mean TAT for ROTEM was significantly lower than CCT (11.2 ± 2.4 v/s 33.5 ± 5 min). FIBTEM parameters A5, A10 and MCF correlated excellently with fibrinogen (r values of 0.858, 0.856,0.855) while EXTEM A5, A10 and MCF correlated strongly with platelet counts (r values of 0.558,0.554, 0.528). In contrast, PT showed only moderate correlations with CT and CFT of EXTEM (r = 0.472, 0.403), and so is APTT with CT and CFT of INTEM (r = 0.452, 0.377). EXTEM versus fibrinogen ROC curve AUC for A5, A10, and MCF EXTEM were 0.812, 0.813 and 0.810 with cut-offs around 35–56.5 mm, yielding sensitivities and specificities in the 70–74% range. For FIBTEM versus fibrinogen AUC for A5, A10, and MCF, FIBTEM were excellent, 0.955, 0.952 and 0.947, with cut-offs of 9.5, 11.5, and 11.5 mm providing sensitivities and specificities > 80%. In the Indian context, ROTEM device acquisition costs are higher, but published models suggest viscoelastic-guided algorithms can be cost-saving in high-volume trauma and cardiac settings by reducing blood product use and transfusion-related complications. In this single-centre exploratory study, ROTEM provides faster and better global assessment of clot generation, firmness and stability than CCT and strongly identifies and differentiates fibrinogen and platelet-related defects. However, its high capital and running costs limit its feasibility as a complete replacement for CCT in India. A pragmatic, cost-conscious model is the selective deployment of ROTEM in tertiary trauma, transplant, and high-risk obstetric centres, using FIBTEM and EXTEM parameters to guide targeted intervention in bleeding management while retaining CCT for broader use and pathway-specific diagnostics.