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

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

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)3337-3342
Number of pages6
JournalKnee Surgery, Sports Traumatology, Arthroscopy
Volume23
Issue number11
DOIs
Publication statusPublished - Jul 11 2014

Fingerprint

Hemostatics
Knee Replacement Arthroplasties
Reoperation
Thrombin
Blood Transfusion
Knee
Randomized Controlled Trials
Control Groups
Hemoglobins
Therapeutics
Hemostasis
Safety

Keywords

  • Floseal
  • Revision arthroplasty
  • Thrombin-based topical haemostatic
  • Total knee replacement
  • Transfusion

ASJC Scopus subject areas

  • Orthopedics and Sports Medicine
  • Surgery

Cite this

Does a thrombin-based topical haemostatic agent reduce blood loss and transfusion requirements after total knee revision surgery? A randomized, controlled trial. / Romanò, Carlo L.; Monti, Lorenzo; Logoluso, Nicola; Romanò, Delia; Drago, Lorenzo.

In: Knee Surgery, Sports Traumatology, Arthroscopy, Vol. 23, No. 11, 11.07.2014, p. 3337-3342.

Research output: Contribution to journalArticle

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AU - Drago, Lorenzo

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N2 - 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.

AB - 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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