Thrombin-JMI (Thrombin Topical) - Summary

THROMBIN-JMI SUMMARY

The thrombin in Thrombin, Topical (Bovine Origin) THROMBIN-JMI® is a protein substance produced through a conversion reaction in which prothrombin of bovine origin is activated by tissue thromboplastin of bovine origin in the presence of calcium chloride. It is supplied as a sterile powder that has been freeze-dried in the final container. Also contained in the preparation are mannitol and sodium chloride. Mannitol is included to make the dried product friable and more readily soluble. The material contains no preservative.

THROMBIN-JMI® is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible.

In various types of surgery, solutions of THROMBIN-JMI® may be used in conjunction with an Absorbable Gelatin Sponge, USP for hemostasis, or any medical device approved by FDA for an indicated use with a specified, approved dosage of Thrombin, Topical (Bovine Origin).

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NEWS HIGHLIGHTS

Published Studies Related to Thrombin-JMI (Thrombin Topical)

Discovery and clinical evaluation of 1-{N-[2-(amidinoaminooxy)ethyl]amino}carbonylmethyl-6-methyl-3-[2,2-difluoro-2-ph enylethylamino]pyrazinone (RWJ-671818), a thrombin inhibitor with an oxyguanidine P1 motif. [2010]
We have identified RWJ-671818 (8) as a novel, low molecular weight, orally active inhibitor of human alpha-thrombin (K(i) = 1.3 nM) that is potentially useful for the acute and chronic treatment of venous and arterial thrombosis. In a rat deep venous thrombosis model used to assess antithrombotic efficacy, oral administration of 8 at 30 and 50 mg/kg reduced thrombus weight by 87 and 94%, respectively...

A safety review of topical bovine thrombin-induced generation of antibodies to bovine proteins. [2009.04]
BACKGROUND: Topical bovine thrombin has been used to accelerate attainment of hemostasis in the surgical setting for >60 years, and its immunogenicity has been widely reported. Although the development of antibodies is inherent in the introduction of any non-self-therapeutic protein such as bovine-sourced thrombin, there are questions about the relationship between the presence of antibodies to constituents of the therapeutic protein preparation and the occurrence of clinically relevant adverse events (AEs). OBJECTIVE: This review examines the proposed mechanisms for the immunogenicity of topical bovine thrombin preparations and summarizes available evidence from randomized clinical trials, observational studies, and case reports to explore possible relationships between the reported immunogenicity of topical bovine thrombin and the occurrence of AEs... CONCLUSIONS: Repeated perioperative exposure to topical bovine thrombin may increase both the prevalence and titers of antibodies to >or=1 protein contained in nonhomogeneous topical bovine thrombin preparations. However, the evidence reviewed does not support a definitive association between preoperative or postoperative generation of anti-bovine protein antibodies and an increased risk of AEs in surgical patients treated with topical bovine thrombin.

Efficacy and safety of topical application of human fibrinogen/thrombin-coated collagen patch (TachoComb) for treatment of air leakage after standard lobectomy. [2004.02]
OBJECTIVES: Persisting air leakage after pulmonary resection remains a significant problem. The aim of the study was to evaluate the incidence of air leakage after standard lobectomy and test the efficacy and safety of TachoComb (TC)... CONCLUSIONS: TC could be proven as well-tolerated and safe. In the subgroup of patients with established air leakage, TC showed superior potential in reduction of intra-operative air leakage as well as in reduction of intensity and duration of postoperative air leakage.

Gelatin-thrombin-based hemostatic sealant for intraoperative bleeding in vascular surgery. [2002.05]
Vascular surgical procedures may be prolonged because of intraoperative bleeding that is not easily controlled by cautery or suture ligation. This trial compared the ability of a new hemostat, FloSealTM Matrix (FM), with a known hemostat, Gelfoam(R) plus thrombin (GT), to control intraoperative bleeding...

Effect of topical and subcutaneous epinephrine in combination with topical thrombin in blood loss during immediate near-total burn wound excision in pediatric burned patients. [1999.09]
Bleeding is a major concern during burn wound excision. To evaluate the efficacy of epinephrine to control blood loss, a prospective cohort of 42 pediatric patients were examined.

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Clinical Trials Related to Thrombin-JMI (Thrombin Topical)

Study of Recombinant Human Thrombin for Bleeding During Surgery [Completed]
The purpose of this study is to determine whether recombinant human Thrombin (rhThrombin) is effective in stopping bleeding during surgery, in comparison with bovine thrombin.

A Study to Compare Human Thrombin Against Bovine Thrombin in Its Ability to Stop Bleeding After Surgery [Completed]
The purpose of this study is to see if Human Thrombin is as effective as Bovine Thrombin in stopping surgical bleeding within 10 minutes of application.

A Prospective, Randomized Trial of Histoacryl Injection Versus Thrombin in the Control of Acute Gastric Variceal Bleeding [Recruiting]
Though histoacryl injection is now regarded as treatment of choice in the control of gastric variceal hemorrhage, it may be associated with a lot of complications such as ulcers, ulcer bleeding, bacterial infections, distant site thrombosis and cerebral vascular accident. On the other hand, thrombin has been shown to be effective in acute hemostasis of bleeding gastric varices, ranging from 70% to 100% has been recorded. The rebleeding rates were between 7% and 50%. Moreover, the benefits of thrombin injection include safety, without inducing ulcers or ulcer bleeding. No incidence of distant thrombosis has ever been reported.

Trial Comparing Outcomes With Merocel Packing or Thrombin-JMI for Anterior Epistaxis [Recruiting]
Epistaxis is a common problem among people of all ages and backgrounds. However, occasionally epistaxis can be severe enough to require emergency room admission. Among the treatment options for epistaxis, nasal packing is the most common approach. This approach requires a return visit to the clinic for removal of the packing. Additionally, there is a great deal of pain during the insertion and removal of this packing. This study aims to justify the further investigation of thrombin as a potential treatment approach for these patients. Thrombin could provide a treatment approach that reduces pain and eliminates the need for a return visit to the clinic.

Evaluating the Role of Thrombin in Saphenous Vein Graft Failure After Heart Bypass Surgery [Recruiting]
Heart bypass surgery, also known as coronary artery bypass graft (CABG) surgery, creates a detour around the blocked part of a heart artery to restore blood supply to the heart muscle. The saphenous vein, located along the inside of the leg, is commonly used to create the bypass in a CABG surgery. An abnormal increase in the blood clotting protein thrombin may cause the saphenous vein graft to close up and eventually fail. This study will evaluate the relationship between thrombin levels and saphenous vein graft failures in people undergoing a CABG procedure.

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Reports of Suspected Thrombin-JMI (Thrombin Topical) Side Effects

Contusion (1),  Haemorrhage (1),  Coagulopathy (1),  Death (1),  Postoperative Wound Infection (1),  Medication Error (1),  Adverse Event (1),  Haematoma (1),  Circumstance or Information Capable of Leading TO Medication Error (1),  Factor V Inhibition (1), more >>