Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass

Summary

The purpose of this trial is to study the effects of preoperative antithrombin supplementation in patients undergoing cardiac surgery with cardiopulmonary bypass in order to maintain antithrombin levels in a range greater than 58% of functional activity and, eventually, to decrease negative clinical outcomes during the ICU stay.

Timeline

Start

2009-06

Primary completion

2011-06

Completion

2011-09

Outcome

Met primary endpoint

registry analysis (superiority or other test); Antithrombin III Treatment Group vs Control Group; p <0.0001; ANCOVA NCT00823082 ↗

paper 26.6% of patients in the control group versus none in the antithrombin group (P = .001). PMID 23102903 ↗

Publications

• Ranucci M, Baryshnikova E, Crapelli GB, Woodward MK, Paez A, Pelissero G. Preoperative antithrombin supplementation in cardiac surgery: a randomized controlled trial. J Thorac Cardiovasc Surg. 2013 May;145(5):1393-9. doi: 10.1016/j.jtcvs.2012.09.061. Epub 2012 Oct 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Antithrombin III	Protein / enzyme biologic	—	—

Indications