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A Randomized Control Trial of Thromboelastography-Guided Transfusion in Cirrhosis for High-Risk Invasive Liver-Related Procedures

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Abstract

Background and Aim

Hemostasis in cirrhosis is dynamic and balanced. Thromboelastography (TEG) assesses global coagulation status. We aimed to assess whether TEG-guided blood product transfusions result in lower blood product requirements in patients with cirrhosis undergoing invasive liver-related procedures as compared to the conventional standard of care (SOC).

Methods

In this open-label, randomized controlled trial, cirrhosis patients with coagulopathy, undergoing invasive liver-related procedures, were randomized to either TEG-guided blood product transfusion or SOC. The primary outcome was difference in the amount of fresh frozen plasma (FFP) and platelet units transfused between the two groups. The secondary outcome was procedure-related bleeding complications within 5 days and any complications until 28 days.

Results

From November 2017 till June 2019, 58 patients were recruited (29: TEG and 29: SOC). Most common procedures performed were percutaneous liver biopsy (n = 48), followed by transjugular intrahepatic portosystemic shunt (n = 2), percutaneous acetic acid injection (n = 2), and transarterial chemoembolization (n = 2). There were no differences in baseline demographics, hemostatic profile, and types of procedures between the two groups. Only nine patients in TEG group received transfusions compared to all patients in SOC (31% vs 100%; P < 0.001). In TEG group, six (20.7%) received FFP (P = 0.753 vs. SOC), two (6.9%) received platelets (P < 0.001 vs. SOC), and 1(3.4%) patient received both FFP and platelet (P ≥ 0.999 vs. SOC) transfusion. None of the patients in either group developed procedure-related bleeding complications until 5 days post-procedure. The complication rates at 28-day follow-up were similar between the groups.

Conclusion

TEG-guided blood product transfusion strategy reduces blood product transfusion without increased risk of bleeding in cirrhotic patients undergoing invasive liver-related procedures (CTRI/2017/12/010822).

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Abbreviations

DIC:

Disseminated intravascular coagulation

FFP:

Fresh frozen plasma

HCC:

Hepatocellular carcinoma

INR:

International normalized ratio

IQR:

Interquartile range

MA:

Maximum amplitude

MELD:

Model for end-stage liver disease

PAI:

Percutaneous acetic acid injection

PNH:

Paroxysmal nocturnal hemoglobinuria

PT:

Prothrombin time

SOC:

Standard of care

TACE:

Transarterial chemoembolization

TEG:

Thromboelastography

TJLB:

Transjugular liver biopsy

TIPS:

Transjugular intrahepatic portosystemic shunt

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Acknowledgments

Authors thank Mr Amar and Mr Dilshad for data keeping.

Funding

The study was investigator (Dr Shalimar) driven, and no funding was available.

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Authors and Affiliations

  1. Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India

    Sudheer K Vuyyuru, Gyanranjan Rout, Deepak Gunjan &  Shalimar

  2. Department of Internal Medicine, All India Institute of Medical Sciences, New Delhi, India

    Achintya D. Singh

  3. Departments of Internal Medicine, Cleveland Clinic, Cleveland, OH, USA

    Achintya D. Singh

  4. Department of Radiodiagnosis, All India Institute of Medical Sciences, New Delhi, India

    Shivanand R. Gamanagatti

Authors
  1. Sudheer K Vuyyuru
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  2. Achintya D. Singh
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  3. Shivanand R. Gamanagatti
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  4. Gyanranjan Rout
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  5. Deepak Gunjan
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  6. Shalimar
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Contributions

SKV was involved in the acquisition of clinical data and drafting of the manuscript; ADS acquired the clinical data and interpreted and drafted the manuscript; SRG conducted percutaneous radiological interventions, analyzed and interpreted the data; GR was involved in the analysis and interpretation of data and revision of manuscript; DG analyzed and interpreted the data and revised the manuscript; S was involved in the study concept and design, analysis and interpretation of data, and critical revision of the manuscript for important intellectual content.

Corresponding author

Correspondence to Shalimar.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Vuyyuru, S.K., Singh, A.D., Gamanagatti, S.R. et al. A Randomized Control Trial of Thromboelastography-Guided Transfusion in Cirrhosis for High-Risk Invasive Liver-Related Procedures. Dig Dis Sci 65, 2104–2111 (2020). https://doi.org/10.1007/s10620-019-05939-2

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  • DOI: https://doi.org/10.1007/s10620-019-05939-2

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