A review of three stand-alone topical thrombins for surgical hemostasis

Cheng, Christine; Meyer‐Massetti, Carla; Kayser, Steven R.

doi:10.1016/j.clinthera.2009.01.005

Cited by 57 publications

(53 citation statements)

References 17 publications

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“…[2,8] As a result of its key role in coagulation, vasoconstriction, and platelet aggregation, thrombin is an attractive choice for a hemostat. [7,10,11] First developed more than 60 years ago, bovine thrombin (bThrombin) is now conservatively estimated to be used in more than 1 million surgical treatments per year in the US alone. [7,10,11] First developed more than 60 years ago, bovine thrombin (bThrombin) is now conservatively estimated to be used in more than 1 million surgical treatments per year in the US alone.…”

Section: Route Of Administrationmentioning

confidence: 99%

Recombinant Human Thrombin

Croxtall

Scott

2009

BioDrugs

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Recombinant human thrombin (rhThrombin) is a serine protease coagulant, manufactured in vitro using recombinant DNA technology, which shares an identical amino acid sequence and similar structure with the native human protein. It is indicated for topical use as an aid to hemostasis in patients undergoing surgery. Topical rhThrombin 1000 U/mL was no less effective than bovine thrombin (bThrombin) 1000 U/mL as a hemostatic agent in a randomized, double-blind, multicenter, phase III trial in patients undergoing various surgical procedures (n = 401). Hemostasis, achieved within 10 minutes, occurred in 95.4% of rhThrombin versus 95.1% of bThrombin recipients (primary endpoint) in the overall surgical cohort. Moreover, hemostasis occurred rapidly, with more than 70% of recipients of rhThrombin or bThrombin achieving hemostasis within 3 minutes. In a post hoc, subgroup analysis of this phase III trial, rhThrombin was also effective in patients undergoing vascular surgery, with hemostasis occurring within 10 minutes at >90% of all vascular anastomotic sites. Significantly fewer patients undergoing various surgical procedures were seropositive for antibodies against rhThrombin than bThrombin 1 month after topical hemostatic treatment in the phase III trial. In a noncomparative, multicenter, phase IIIb trial (n = 200), 1 month after vascular or spinal surgery where topical rhThrombin was used as a hemostat, the incidence of patients with evidence of anti-rhThrombin antibody formation was zero and did not differ between those classified as seropositive or seronegative for pre-existing anti-bThrombin antibodies at baseline (primary endpoint). rhThrombin was generally well tolerated during the treatment and 1-month follow-up periods in adult surgical patients, with a tolerability profile similar to that of bThrombin.

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Section: Route Of Administrationmentioning

confidence: 99%

Recombinant Human Thrombin

Croxtall

Scott

2009

BioDrugs

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“…Topical thrombin is available as a reconstituted powder or solution that is directly applied to an open wound. It can be used alone or in combination with a fibrin-based product or a hemostatic sponge [4]. Currently there are three types of topical thrombin available (Table 1) [5–7]; human plasma derived (h-thrombin), bovine plasma derived (b-thrombin) and recombinant (r-thrombin).…”

Section: Introductionmentioning

confidence: 99%

Catheter-directed endovascular application of thrombin: Report of 3 cases and review of the literature

et al. 2017

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Purpose To report 3 new cases of catheter-directed endovascular application of thrombin and explore trends by analysis of published case series. Materials and Methods Institutional Review Board approved this retrospective study. All cases of non-tumoral arterial embolization performed from January 2003 to January 2015 at our institution were retrospectively reviewed. Thrombin was used in 7 of 589 cases. In 3 cases intra arterial thrombin was injected via catheter to treat active hemorrhage. Four cases were excluded due to percutaneous injection into visceral pseudoaneurysms (n=3) and making ex vivo autologous clot to be injected via catheter (n=1). Fisher’s exact and the Wilcoxon rank sum tests were used to assess for association with acute nontarget thrombosis. Results Catheter-directed thrombin was used in 3/589 (0.5%) cases at our institution. All three cases were technically successful with no further bleeding (100%). Nontarget thrombosis of proximal branches occurred in 2 patients (67%) with no significant clinical consequences. Including our 3 cases, a total of 28 cases were reviewed. Of the variables examined - location (p=0.99), size (p=0.66) and etiology of vascular lesion (p=0.92), pseudoaneurysm neck anatomy (p=0.14), thrombin units (p=0.47), volume (p=0.76) or technique of use of small doses (p=0.99), use of other embolic material (p=0.67) and use of adjunct techniques (p=0.99) - none were found to be significantly associated with acute nontarget thrombosis. Technical success was 96% with no reports of reperfusion after treatment. Conclusions Catheter-directed endovascular thrombin can be an additional tool to treat pseudoaneurysms not amenable to conventional embolization. Further studies are required to optimize technique and outcomes.

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“…9 Hemostatic chemicals such as ethanol, cyanoacrylates, polyvinylalcohol, fibrinogen/fibrin, collagen sponges, or synthetic hydrogels are limited by shelf life, immunogenicity, and cytotoxic byproducts derived from nonhuman or allogenic sources. 8,10,11 …”

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confidence: 99%

A Nanostructured Synthetic Collagen Mimic for Hemostasis

et al. 2014

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Collagen is a major component of the extracellular matrix and plays a wide variety of important roles in blood clotting, healing, and tissue remodeling. Natural, animal derived, collagen is used in many clinical applications but concerns exist with respect to its role in inflammation, batch-to-batch variability, and possible disease transfection. Therefore, development of synthetic nanomaterials that can mimic the nanostructure and properties of natural collagen has been a heavily pursued goal in biomaterials. Previously, we reported on the design and multihierarchial self-assembly of a 36 amino acid collagen mimetic peptide (KOD) that forms nanofibrous triple helices that entangle to form a hydrogel. In this report, we utilize this nanofiber forming collagen mimetic peptide as a synthetic biomimetic matrix useful in thrombosis. We demonstrate that nanofibrous KOD synthetic collagen matrices adhere platelets, activate them (indicated by soluble P-selectin secretion), and clot plasma and blood similar to animal derived collagen and control surfaces. In addition to the thrombotic potential, THP-1 monocytes incubated with our KOD collagen mimetic showed minimal proinflammatory cytokine (TNF-α or IL-1β) production. Together, the data presented demonstrates the potential of a novel synthetic collagen mimetic as a hemostat.

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A review of three stand-alone topical thrombins for surgical hemostasis

Cited by 57 publications

References 17 publications

Recombinant Human Thrombin

Recombinant Human Thrombin

Catheter-directed endovascular application of thrombin: Report of 3 cases and review of the literature

A Nanostructured Synthetic Collagen Mimic for Hemostasis

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