In 2 data series, the rate of thromboembolic complication in surgical patients with hereditary AT deficiency ranged from 17% to 22%1,2


SURGICAL CASE STUDY: ROBERT

Age:40 years

Height5'11"

Weight190 lb (86 kg)



 

Family History: Deep vein thrombosis, peripheral artery disease, and myocardial infarction

Chief Complaint: Tightness of the chest, back, and shoulders

Initial Evaluation/Suggested Treatment: Atherosclerosis and occlusion of the left anterior descending branch requiring coronary artery bypass grafting (CABG)

Complication: Hereditary AT deficiency (AT activity 48% of normal)

Treatment Goals and Plan: To prevent thrombotic complications, AT activity will be increased from 48% to 120% of normal on the day of surgery with THROMBATE III. Robert will continue treatment throughout the duration of his hospital stay to maintain his levels at 80% to 120% of normal

 

Hereditary AT deficiency
increases thrombotic risk 20-fold3


 


THROMBATE III® (antithrombin III [human]) is indicated in patients with hereditary antithrombin deficiency for treatment and prevention of thromboembolism and for prevention of perioperative and peripartum thromboembolism.

Hypersensitivity reactions may occur. Should evidence of an acute hypersensitivity reaction be observed, promptly interrupt the infusion and begin appropriate treatment.

Because THROMBATE III is made from human blood, it may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. There is also the possibility that unknown infectious agents may be present in the product.

Perform coagulation tests to avoid excessive or insufficient anticoagulation and monitor for bleeding or thrombosis. Measure functional plasma AT levels with amidolytic or clotting assays; do not use immunoassays.

In clinical studies, the most common adverse reactions (≥5% of subjects) were dizziness, chest discomfort, nausea, dysgeusia, and pain (cramps).

The anticoagulant effect of heparin is enhanced by concurrent treatment with THROMBATE III in patients with hereditary AT deficiency. Thus, in order to avoid bleeding, the dosage of heparin (or low molecular weight heparin) may need to be reduced during treatment with THROMBATE III.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.


References

  1. Tengborn L, Bergqvist D. Surgery in patients with congenital antithrombin III deficiency. Acta Chir Scand. 1988;154(3):179-183.
  2. Pabinger I, Schneider B. Thrombotic risk in hereditary antithrombin III, protein C, or protein S deficiency. A cooperative, retrospective study. Gesellschaft fur Thrombose-und Hamostaseforschung (GTH) Study Group on Natural Inhibitors. Arterioscler Thromb Vasc Biol . 1996;16(6):742-748.
  3. Franchini M, Veneri D, Salvagno GL, et al. inherited Thrombophilia. Crit Rev Clin Lab Sci. 2006;43(3):249-290.