Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery

Summary

This trial is conducted in Canada, Asia, Europe and USA. The aim of this clinical trial is to investigate the effect and safety of rFXIII on transfusion needs in patients undergoing heart surgery.

Timeline

Start

2009-07

Primary completion

2011-02

Completion

2011-02

Outcome

Missed primary endpoint

registry Placebo vs FXIII17.5IU/Kg; p = 0.8648; Odds Ratio (OR) 1.0482 (95% CI 0.6095 to 1.8029) NCT00914589 ↗

paper Replenishment of FXIII levels after cardiopulmonary bypass had no effect on transfusion avoidance, transfusion requirements, or reoperation PMID 23820174 ↗

Publications

• Results Song HK, von Heymann C, Jespersen CM, Karkouti K, Korte W, Levy JH, Ranucci M, Saugstrup T, Sellke FW. Safe application of a restrictive transfusion protocol in moderate-risk patients undergoing cardiac operations. Ann Thorac Surg. 2014 May;97(5):1630-5. doi: 10.1016/j.athoracsur.2013.12.025. Epub 2014 Mar 19.
• Karkouti K, von Heymann C, Jespersen CM, Korte W, Levy JH, Ranucci M, Sellke FW, Song HK. Efficacy and safety of recombinant factor XIII on reducing blood transfusions in cardiac surgery: a randomized, placebo-controlled, multicenter clinical trial. J Thorac Cardiovasc Surg. 2013 Oct;146(4):927-39. doi: 10.1016/j.jtcvs.2013.04.044. Epub 2013 Jun 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	catridecacog	Protein / enzyme biologic	17.5 iu/kg	Intravenous
Subject	catridecacog	Protein / enzyme biologic	35 iu/kg	Intravenous

Indications