Fibrinogen Deficiency in Complex Cardiac Surgery Clinical Trial
Official title:
Efficacy and Safety of Haemocomplettan® P in Patients Experiencing Microvascular Bleeding While Undergoing Elective Complex Cardiac Surgery
Fibrinogen concentrate is increasingly used in cardiac surgery to reverse coagulopathy. Whether its use reduces blood loss, transfusion and occurrence of clinical adverse events remains unknown.
Fibrinogen concentrate is increasingly used in surgical patients suffering excessive
bleeding refractory to conventional hemostasis treatment. However, these studies published
so far comprise small study groups with questionable study designs.
The aim of this study is to determine whether fibrinogen concentrate reduces blood loss and
transfusion in patients undergoing elective complex cardiac surgery.
By choosing the domain of complex cardiac surgery which is prone for excessive blood loss
and transfusion, we will focus on subjects undergoing high risk procedures. Hereby we
hypothesize that administration of fibrinogen concentrate improves hemostasis in patients
experiencing microvascular bleeding during complex cardiac surgery. This improvement of the
hemostasis is measured by reduced blood loss and transfusion of blood products during
surgery and the postoperative period.
Furthermore, we hypothesize that fibrinogen concentrate is safe and well tolerated in
patients undergoing complex cardiac surgery. This hypothesis will be investigated by a
detailed study of clinical outcomes.
Update regarding interim-analysis:
On 09 August 2013 an interim-analysis was performed as described in the protocol. The
outcome was discussed during the Steering Committe of 09 October 2013. During that meeting,
based on the results of the interim-analysis, the continuation of the current study was
ordered.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment