Indications for: THROMBIN-JMI
Aid to hemostasis for oozing blood and minor bleeding from accessible capillaries and small venules. Adjunct for surgical hemostasis with absorbable gelatin sponge.
In a double-blinded, controlled trial, patients were randomly assigned to receive Thrombin-JMI (n=206) or recombinant human thrombin (n=205) as adjuncts to hemostasis in liver resection, spine, peripheral arterial bypass, and dialysis access surgeries; 401 patients completed the trial.
The reported adverse reactions in both treatment groups were: cardiac events (18%), hypersensitivity (17%), other infections (15%), bleeding (11%), postoperative wound infection (10%) and thromboembolic events (5%).
Among 200 patients who were evaluated for the presence of antibodies to Thrombin-JMI, 10 patient (5%) were positive at baseline and 43 (21.5%) after treatment. The seroconversion rate in the Thrombin-JMI group was 18.4%.
In another prospective, double-blinded, controlled trial patients were randomly assigned to receive Thrombin-JMI (n=152) or human thrombin (n=153) applied topically to the target bleeding site with a gelatin sponge.
Sixteen out of 126 (12.7%) patients in the Thrombin-JMI arm demonstrated seroconversion for at least 1 of the 4 antibodies assayed. Serious adverse reactions (pyrexia and post-procedural hematoma) were reported in 2 patients in the Thrombin-JMI group.
The effect of repeat exposure was evaluated in a prospective, double-blinded, controlled trial that included 72 patients with diabetic foot ulcers, using a gel prepared with Thrombin-JMI and autologous platelet rich plasma that was applied weekly for 12 weeks. No serious adverse reactions related to the gel treatment were reported.
In an open-label, observational study (MOSAIC), the effect of possible exposure to Thrombin-JMI on activated partial thromboplastin time (aPTT) at 48 hours post-surgery in patients with likelihood of prior exposure to Thrombin-JMI within the past 4 years was assessed.
The impact of exposure to Thrombin-JMI in 78 patients who were positive for anti-bovine thrombin (aBT) antibodies prior to surgery was compared with 140 patients who did not have any aBT antibodies and were not exposed to Thrombin-JMI.
The study did not meet the primary endpoint, a mean change from baseline in aPTT at 48 hours post-surgery. The study was not powered to detect coagulopathy related to an immune response after bovine thrombin use.
For topical use only. See full labeling. Profuse bleeding (eg, abraided surfaces of liver or spleen): 1000 IU/mL. General use (eg. plastic surgery, dental extractions, skin grafting): 100 IU/mL. May dilute to prepare intermediate strengths, if needed. Oozing surfaces: may use dry form.
Direct injection into the circulatory system. Re-exposure if there are known or suspected antibodies to bovine thrombin and/or factor V. Treatment of severe or brisk arterial bleeding.
Severe bleeding and thrombosis complications.
Not for injection. Allergic reactions: have supportive measures available. Thrombosis. Antibody formation may interfere with hemostasis. Monitor for abnormal coagulation lab values, bleeding, thrombosis. Pregnancy. Nursing mothers.
Hypersensitivity reactions, bleeding, anemia, post-op wound infection, thromboembolic events, hypotension, pyrexia, tachycardia, thrombocytopenia.
Vials—1 (w. diluent); Pump Spray Kit (20000 IU)—1 (w. diluent); Syringe Spray Kit (5000 IU, 20000 IU)—1 (w. diluent); Epistaxis Kit (5000 IU)—1 (w. diluent); Gelfoam-JMI Kit (gelatin sponge or powder)—1