Haemocomplettan� P During Elective Complex Cardiac Surgery

Condition(s) targeted: Fibrinogen Deficiency in Complex Cardiac Surgery

Intervention: Haemocomplettan® P (Drug); Human albumin (Placebo) (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Isala

Official(s) and/or principal investigator(s):
Arno P Nierich, MD, PhD., Principal Investigator, Affiliation: Isala Klinieken Zwolle

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.

Official title: Efficacy and Safety of Haemocomplettan® P in Patients Experiencing Microvascular Bleeding While Undergoing Elective Complex Cardiac Surgery

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: To determine whether fibrinogen concentrate infusion reduces perioperative blood loss.

Secondary outcome:

To determine whether fibrinogen concentrate infusion reduces postoperative blood loss.

To determine whether fibrinogen concentrate infusion reduces postoperative transfusion of blood products during elective complex cardiac surgery.

To determine whether fibrinogen concentrate infusion is safe and well-tolerated.

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Eighteen years of age or older.

- Undergoing elective complex cardiac surgery.

- Understood and willingly given written informed consent.

- Experience clinically relevant non-surgical microvascular bleeding following removal

of cardiopulmonary bypass. Exclusion Criteria:

- Positive pregnancy test, pregnancy or lactation.

- Undergoing an emergency operation.

- Proof or suspicion of a congenital or acquired coagulation disorder.

- Clopidogrel use in the 5 days preceding surgery.

- INR >1. 4 if on coumadin.

Department Anesthesiology & Intensive Care, Zwolle, Overijssel 8011 JW, Netherlands

Department of Cardiothoracic Anaesthesia and Intensive Care Isala Klinieken, Zwolle, Overijssel 8011 JW, Netherlands

Starting date: February 2011
Last updated: December 15, 2014