FXIII Replenishment following Cardiopulmonary Bypass Surgery

• Research type

  Research Study

• Full title

  A Multi-Centre, Randomised, Double-Blind, Placebo Controlled Trial on Efficacy and Safety of FXIII Replenishment with two different Doses of Recombinant Factor XIII following Cardiopulmonary Bypass Surgery.

• IRAS ID

  17183

• Sponsor organisation

  Novo Nordisk

• Eudract number

  2008-006324-62

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Factor XIII (FXIII) is a protein which naturally occurs in the blood and is the final step in establishing a firm blood clot. In some people who have reduced levels of FXIII a clot may form but will easily be dissolved and bleeding may resume. During and after cardiac surgery, a significant reduction in FXIII levels is often observed due to use and loss. At least half the patients will receive a blood transfusion to treat this condition, but a variety of adverse events are associated with transfusions of donated blood products. Failure or delays in controlling bleeding following cardiac surgery will often increase risk of illness or death.The primary objective of this study is to evaluate if the administration of recombinant FXIII (rFXIII) can lead to transfusion avoidance. rFXIII is genetically engineered, and is similar in structure to the coagulation Factor XIII and has the same activity. People who are scheduled to undergo heart surgery which requires the use of a cardiopulmonary bypass (where their blood will have to go through a heart-lung machine to allow the surgeon to operate on their heart) will be asked to take part in this study. Participants will first be screened, and if they are eligible, will be randomised in a 1:1:1 ratio to either: 17.5 IU/kg rFXIII, 35 IU/kg rFXIII or placebo. The study medication will be administered towards the end of surgery, given directly into the vein (intravenous infusion), after they have been taken of the cardiopulmonary bypass. The subjects will be monitored closely for 7 days (or until discharge, whichever comes first) after dosing of trial product, to evaluate the effectiveness and safety of rFXIII. In addition, the subjects will attend a safety follow-up visit 5-7 weeks later.This study will be sponsored by Novo Nordisk; Novo Nordisk A/S, Novo Alle, Bagsvaerd, DK-2880 Denmark. A total of 408 patients will be enrolled at up to 26 sites in approximately 9 countries.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  09/H0308/116

• Date of REC Opinion

  26 Jun 2009

• REC opinion

  Further Information Favourable Opinion