A Phase 3, Randomized, Double-Blind Comparative Study of the Efficacy and Safety of Topical Recombinant Human Thrombin and Bovine Thrombin in Surgical Hemostasis

Chapman, William C.; Singla, Neil; Genyk, Yuri; McNeil, James W.; Renkens, Kenneth L.; Reynolds, Thomas; Murphy, Aileen

doi:10.1016/j.jamcollsurg.2007.03.020

Cited by 161 publications

(187 citation statements)

References 18 publications

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“…This increase was not seen in those with anti-rhThrombin antibodies (n = 3) compared with those in the rhThrombin group that did not develop antibodies (n = 195) (Chapman et al 2007).…”

Section: Recombinant Human Thrombin (Rhthrombin)mentioning

confidence: 79%

“…The recent FDA approval of human thrombin has provided an alternative to bovine thrombin, but has the theoretic risk of viral transmission. The more recent development and FDA approval of a recombinant protein thrombin product provides yet another potential alternative, with equal effi cacy to bovine thrombin, without the attendant risk of antigenicity (Chapman et al 2007).…”

Section: Discussionmentioning

confidence: 99%

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Clinical use of topical thrombin as a surgical hemostat

Weaver¹

2008

BTT

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When surgical ligation of bleeding fails, or is not possible, surgeons rely on a number of hemostatic aids, including thrombin. This review discusses the history, pharmacology and clinical application of thrombin as a surgical hemostat. The initial thrombin was bovine in origin, but its use has been complicated by the formation of antibodies that cross react with human coagulation factors. This has been associated with life threatening bleeding and in some circumstances anaphylaxis and death. Human thrombin, isolated from pooled plasma of donors, has been developed in an effort to minimize these risks, but its downside is the potential of transmitting blood-borne pathogens and limited availability. Recently a recombinant thrombin has been developed and approved for use by the FDA. It has the advantage of being minimally antigenic and devoid of the risk if viral transmission. Thrombin is often used in conjunction with other hemostatic aids, including absorbable agents (like gelfoam, collagen, and cellulose), and with fi brinogen in fi brin glues. The last part of this review will discuss these agents in detail, and review their clinical applications.

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“…This increase was not seen in those with anti-rhThrombin antibodies (n = 3) compared with those in the rhThrombin group that did not develop antibodies (n = 195) (Chapman et al 2007).…”

Section: Recombinant Human Thrombin (Rhthrombin)mentioning

confidence: 79%

Section: Discussionmentioning

confidence: 99%

Clinical use of topical thrombin as a surgical hemostat

Weaver¹

2008

BTT

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“…The method is very efficient, but has a low risk of arterial embolisation and thrombosis, if the neck is large and short. There is also a risk of sensitisation to bovine thrombin, which has been lowered by the use of recombinant human thrombin 5,6 . The cost of thrombin preparation is high (around 300 Euros) and has a short expiry date.…”

Section: Discussionmentioning

confidence: 99%

Sealing pseudo-aneurysms of the femoral artery with saline injection: a new technique

et al. 2012

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Aims: Pseudo-aneurysm (PA) of the femoral artery is the most frequent complication after diagnostic or therapeutic catheterisation. PA may manifest with large and painful haematoma or compression of the adjacent nerve and vein. Among several therapeutic approaches, compression by injection of saline around the neck is a recent and promising method. To explore compression with saline as an alternative treatment for iatrogenic femoral artery PA was the aim of this study. Methods and results:From December 2009 to January 2011, all consecutive patients with symptomatic PA were included in this study. After ultrasonic assessment, the PA neck was occluded by injection of a saline/ lidocaïne (0.2%) mixture in the soft tissue at its vicinity, followed by a short echo-guided compression. Outcome was assessed at one and 30 days by duplex sonography. Eleven patients with PA requiring immediate treatment were included. All patients had at least one PA cavity. Moreover, four patients had multiple pulsatile cavities and seven patients had large thigh or abdominal haematoma, with either active bleeding, compression of adjacent organ or hypotension. Three patients had very short PA neck. The mean injected volume was 47±11 ml. The mean compression time until the PA was closed was 6±3 minutes. At one and 30 days, all PA remained occluded without any complication related to the procedure. Conclusions:Saline injection to seal PA is feasible, safe and very effective. The technique is rapid and well tolerated, and allows, after limited training, the closure of very large PA, even in case of emergency. This new technique is more comfortable for the patient and the operator, and surely more economical than thrombin injection or surgical arterial suture.

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“…thrombin with similar efficiency but with significantly lower risk of immunologic impact (Chapman et al, 2007) (Chang, 1986), sodium dodecyl sulfatepolyacrylamide gel electrophoresis (SDS-PAGE), hydrophobic interaction HPLC (Karlsson, 2003). Presented work has been focused on development of analytical method based on RP-HPLC.…”

Section: Comparison Of Two Rp-hplc Methods For Determination Of Recommentioning

confidence: 99%

Comparison of two RP-HPLC methods for determination of recombinant human thrombin in pharmaceutical formulations. / Porovnanie dvoch RP-HPLC metód pre stanovenie rekombinantného ľudského trombínu vo farmaceutických formuláciách

Bartoš

Murányi

Šnauko

2015

Acta Facultatis Pharmaceuticae Universitatis Comenianae

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Two reversed-phase high performance liquid chromatography analytical methods (Method I and Method II) for determination of assay of recombinant human thrombin in pharmaceutical formulations were developed and validated. Analysis was performed on chromatographic system Agilent 1200 series SL with diode array detection and mass selective detection. Method I was intended for faster determination of thrombin assay. Gradient programme was optimised to achieve sufficient separation and acceptable runtime. Chromatographic analysis was performed on analytical column Grace Vydac, C4 250 × 4.6 mm, 5 mm. Method II is Method I adapted to use the mass selective detector. Chromatographic separation was performed on analytical column Zorbax 300SB-C8 SolvSaver Plus, 150 × 3 mm, 3.5 mm. Both analytical methods were validated with respect to specificity, linearity, precision and accuracy. The response of thrombin was a linear function of concentration over the range 0.1-1.0 mg/ml. Precision and accuracy of thrombin was evaluated at three concentration levels low (0.2 mg/ml), medium (0.4 mg/ml) and high (0.8 mg/ml). Both validated methods have been successfully applied for determination of assay and thrombin degradation products in pharmaceutical formulations.

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A Phase 3, Randomized, Double-Blind Comparative Study of the Efficacy and Safety of Topical Recombinant Human Thrombin and Bovine Thrombin in Surgical Hemostasis

Cited by 161 publications

References 18 publications

Clinical use of topical thrombin as a surgical hemostat

Clinical use of topical thrombin as a surgical hemostat

Sealing pseudo-aneurysms of the femoral artery with saline injection: a new technique

Comparison of two RP-HPLC methods for determination of recombinant human thrombin in pharmaceutical formulations. / Porovnanie dvoch RP-HPLC metód pre stanovenie rekombinantného ľudského trombínu vo farmaceutických formuláciách

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