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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)

Edoxaban effects on bleeding following punch biopsy and reversal by a 4-factor prothrombin complex concentrate. [2015]
CONCLUSIONS: The 4F-PCC dose-dependently reversed the effects of edoxaban (60

Is there evidence that fresh frozen plasma is superior to antithrombin administration to treat heparin resistance in cardiac surgery? [2014]
A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was, 'in [patients with heparin resistance] is [treatment with FFP] superior [to antithrombin administration] in [achieving adequate anticoagulation to facilitate safe cardiopulmonary bypass]?' More than 29 papers were found using the reported search, of which six represented the best evidence to answer the clinical question...

Thrombin generation mediators and markers in sepsis-associated coagulopathy and their modulation by recombinant thrombomodulin. [2014]
Severe sepsis remains the most common cause of death in critically ill patients, and thrombin plays a crucial role in the pathogenesis of sepsis-associated disseminated intravascular coagulation (DIC). The purpose of this study was to profile prothrombin fragment (F1.2), thrombin-antithrombin complex (TAT), and d-dimer (DD) throughout the course of hospital stay in patients identified with sepsis...

Vorapaxar in patients with peripheral artery disease and acute coronary syndrome: insights from Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRACER). [2014]
ACS patients with documented PAD... CONCLUSIONS: Patients with NSTE ACS and PAD were at increased risk for ischemic

Vorapaxar, a platelet thrombin-receptor antagonist, in medically managed patients with non-ST-segment elevation acute coronary syndrome: results from the TRACER trial. [2014]
prognosis and outcomes of vorapaxar vs. placebo... CONCLUSIONS: NSTEACS patients who were initially medically managed had a higher

more studies >>

Clinical Trials Related to Thrombin-JMI (Thrombin Topical)

Trial Comparing Outcomes With Merocel Packing or Thrombin-JMI for Anterior Epistaxis [Terminated]
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.

Observational Study Assessing the Impact of Exposure to THROMBIN-JMI´┐Ż on Coagulation Parameters. [Completed]
The purpose of this study is to assess the effect of possible exposure to THROMBIN JMI« on activated partial thromboplastin time (aPTT) at 48 hours post surgery in subjects with likelihood of prior exposure to THROMBIN JMI« within the past 4 years.

Safety and Efficacy of Topical Thrombin (Human) Grifols as an Adjunct to Hemostasis During Open Surgeries [Recruiting]
This purpose of this clinical trial is to study the safety and efficacy of Topical Thrombin (Human) Grifols as an add-on treatment to help stop bleeding during vascular, liver, soft tissue, and spinal open surgical procedures. Approximately 180 subjects will be treated with either Topical Thrombin (Human) Grifols (120 subjects) or Bovine Thrombin JMI« (60 subjects). Subjects will be evaluated for identification of a target bleeding site (TBS) in which control of bleeding by standard surgical techniques is ineffective or impractical and requires an additional treatment to stop the bleeding. The Investigator (surgeon) will rate the intensity of bleeding at the TBS. Topical Thrombin (Human) Grifols or Bovine Thrombin JMI will then be applied to the TBS and the amount of bleeding at the TBS will be examined.

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.

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.

more trials >>

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 >>


Page last updated: 2015-08-10

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