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Does a thrombin-based topical haemostatic agent reduce blood loss and transfusion requirements after total knee revision surgery? A randomized, controlled trial

  • Knee
  • Published:
Knee Surgery, Sports Traumatology, Arthroscopy Aims and scope

Abstract

Purpose

The aim of the present study was to assess the efficacy of a thrombin-based topical haemostatic in reducing blood requirements after total knee replacement (TKR) revision surgery.

Methods

This prospective, randomized, controlled study was designed to evaluate the haemostatic efficacy and safety of a thrombin-based topical haemostatic (Floseal) versus standard treatment in patients receiving total knee revision arthroplasty. The decrease in haemoglobin values postsurgery and the blood units transfused were recorded. The decision to transfuse was made by a surgeon blinded to the patient’s group allocation.

Results

Forty-eight patients were enroled in the study; twenty-four patients each were randomized to the treatment and control groups, respectively. The median decrease in haemoglobin concentration on the first postoperative day was 2.2 g/dL in the treatment group and 2.7 g/dL in the control group. A significant reduction in units of blood transfused was also observed in the treatment group compared with the control group [1.1 ± 1.13 (range 0–4) vs. 1.9 ± 1.41 (range 0–5) blood units; P = 0.04]. No major treatment-related adverse events were recorded in the study.

Conclusions

This study shows that a thrombin-based topical haemostatic reduces the need for blood transfusion in TKR revision surgery.

Clinical relevance

A thrombin-based topical haemostatic agent can be an appropriate solution to enhance haemostasis and vessel sealing at the operative site in TKR revision surgery, in order to reduce the need for blood transfusion after surgery.

Level of evidence

II.

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Acknowledgments

The authors would like to thank Simone Boniface and Sheridan Henness of in Science Communications, Springer Healthcare, who provided medical writing assistance. This assistance was funded by Baxter (Italy). The study was partially funded by the Italian Ministry of Health, Research Project # 4077/2011. CLR is serving as the President of the European Bone and Joint Infection Society and act as scientific project coordinator within the Research Orthopaedic Institute Galeazzi in Milan, Italy.

Conflict of interest

None of the authors has any conflict of interest to disclose.

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Authors and Affiliations

  1. Department of Bone and Joint Infections and Reconstructive Surgery, IRCCS Orthopaedic Institute Galeazzi, Via Riccardo Galeazzi 4, 20161, Milan, Italy

    Carlo L. Romanò, Lorenzo Monti, Nicola Logoluso & Delia Romanò

  2. Laboratory of Clinical Chemistry and Microbiology, IRCCS Orthopedic Institute Galeazzi, Via Riccardo Galeazzi 4, 20161, Milan, Italy

    Lorenzo Drago

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  1. Carlo L. Romanò
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Correspondence to Carlo L. Romanò.

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Romanò, C.L., Monti, L., Logoluso, N. et al. Does a thrombin-based topical haemostatic agent reduce blood loss and transfusion requirements after total knee revision surgery? A randomized, controlled trial. Knee Surg Sports Traumatol Arthrosc 23, 3337–3342 (2015). https://doi.org/10.1007/s00167-014-3153-8

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