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Recombinant human thrombin: in surgical hemostasis.
Jamie D Croxtall1, Lesley J Scott
1Adis, a Wolters Kluwer Business, Auckland, New Zealand. demail@adis.co.nz
Biodrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
|September 17, 2009
Summary
Recombinant human thrombin (rhThrombin) is as effective as bovine thrombin (bThrombin) for surgical hemostasis. rhThrombin showed a lower incidence of antibody formation and good tolerability, making it a safe alternative for controlling bleeding during surgery.
Area of Science:
- Biochemistry
- Surgical Innovation
- Immunology
Background:
- Recombinant human thrombin (rhThrombin) is a bioengineered hemostatic agent.
- It is identical in sequence and structure to native human thrombin.
- rhThrombin is indicated for topical use to aid hemostasis during surgery.
Purpose of the Study:
- To compare the efficacy and immunogenicity of topical rhThrombin versus bovine thrombin (bThrombin) in surgical patients.
- To evaluate the safety and tolerability profile of rhThrombin in diverse surgical settings.
Main Methods:
- A randomized, double-blind, multicenter, phase III trial (n=401) compared rhThrombin with bThrombin for hemostasis.
- A subsequent phase IIIb trial (n=200) assessed antibody formation after rhThrombin use in vascular and spinal surgery.
- Hemostasis achievement within 10 minutes and antibody seropositivity were primary endpoints.
Main Results:
- rhThrombin demonstrated non-inferior efficacy to bThrombin, achieving hemostasis in 95.4% vs 95.1% of patients.
- Rapid hemostasis (<3 minutes) was observed in over 70% of patients in both groups.
- Significantly fewer patients developed antibodies against rhThrombin compared to bThrombin.
- Zero incidence of new anti-rhThrombin antibody formation was observed in the phase IIIb trial.
Conclusions:
- Topical rhThrombin is a safe and effective hemostatic agent comparable to bThrombin.
- rhThrombin exhibits a favorable immunogenicity profile with reduced antibody development.
- These findings support rhThrombin as a viable alternative for surgical hemostasis.
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