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Thrombate III (Antithrombin III) - Summary



Antithrombin III (Human), THROMBATE III® is a sterile, nonpyrogenic, stable, lyophilized preparation of purified human antithrombin III.

THROMBATE III is indicated for the treatment of patients with hereditary antithrombin III deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism.

Subjects with AT-III deficiency should be informed about the risk of thrombosis in connection with pregnancy and surgery and about the inheritance of the disease.

The diagnosis of hereditary antithrombin III (AT-III) deficiency should be based on a clear family history of venous thrombosis as well as decreased plasma AT-III levels, and the exclusion of acquired deficiency.

AT-III in plasma may be measured by amidolytic assays using synthetic chromogenic substrates, by clotting assays, or by immunoassays. The latter does not detect all hereditary AT-III deficiencies.16

The AT-III level in neonates of parents with hereditary AT-III deficiency should be measured immediately after birth. (Fatal neonatal thromboembolism, such as aortic thrombi in children of women with hereditary antithrombin III deficiency, has been reported.)17

Plasma levels of AT-III are lower in neonates than adults, averaging approximately 60% in normal term infants.18,19 AT-III levels in premature infants may be much lower.18,19 Low plasma AT-III levels, especially in a premature infant, therefore, do not necessarily indicate hereditary deficiency. It is recommended that testing and treatment with Antithrombin III (Human), THROMBATE III® of neonates be discussed with an expert on coagulation.11

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Published Studies Related to Thrombate III (Antithrombin III)

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...

Antithrombin III for critically ill patients. [2008.07.16]
CONCLUSIONS: AT III cannot be recommended for critically ill patients based on the available evidence. A randomized controlled trial of AT III, without adjuvant heparin, with prespecified inclusion criteria and good bias protection is needed.

Antithrombin for respiratory distress syndrome in preterm infants. [2006.10.18]
CONCLUSIONS: Preterm infants with RDS are unlikely to benefit from AT treatment and may be harmed.

Benefit/risk profile of high-dose antithrombin in patients with severe sepsis treated with and without concomitant heparin. [2006.05]
A randomised, prospective, placebo-controlled phase III multicentre clinical trial (KyberSept) has been performed to test the efficacy of high-dose antithrombin therapy in patients with severe sepsis. Concomitant low-dose heparin has been routinely given in two thirds of patients for deep vein thrombosis prophylaxis...

High-dose antithrombin III in the treatment of severe sepsis in patients with a high risk of death: efficacy and safety. [2006.02]
OBJECTIVE: To explore if patients with severe sepsis and with a predicted high risk of death (according to the Simplified Acute Physiology Score II) might have a treatment benefit from high-dose antithrombin III... CONCLUSIONS: Treatment with high-dose antithrombin III may increase survival time up to 90 days in patients with severe sepsis and high risk of death. This benefit may even be stronger when concomitant heparin is avoided.

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Clinical Trials Related to Thrombate III (Antithrombin III)

Antithrombin III in Infants With Cardiopulmonary Bypass (CPB) [Recruiting]
The purpose of this study is to discern whether supplementation of Antithrombin III will decrease coagulation and inflammation associated with cardiopulmonary bypass in infants undergoing cardiac surgery.

Anti-thrombin III (ATIII) vs Placebo in Children (<7mo) Undergoing Open Congenital Cardiac Surgery [Recruiting]
The purpose of this study is to test whether the administration of ATIII during the intra-operative period results in improved anticoagulation for cardiopulmonary bypass (CPB) and an attenuation of the activation of the coagulation cascade, as represented by a decrease in fibrin degradation products. The investigators believe this benefit would extend into the post-operative period resulting in a decreased incidence of thrombosis generation, as represented by a decrease in fibrin degradation products in the ICU period.

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Page last updated: 2014-11-30

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