Haemocomplettan® P During Elective Complex Cardiac Surgery

Last updated: December 15, 2014
Sponsor: Isala
Overall Status: Completed

Phase

2/3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT01124981
BI1401_2010
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 removalof cardiopulmonary bypass.

Exclusion

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.

Study Design

Total Participants: 120
Study Start date:
February 01, 2011
Estimated Completion Date:
December 31, 2014

Study 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.

Connect with a study center

  • Department Anesthesiology & Intensive Care

    Zwolle, Overijssel 8011 JW
    Netherlands

    Site Not Available

  • Department of Cardiothoracic Anaesthesia and Intensive Care Isala Klinieken

    Zwolle, Overijssel 8011 JW
    Netherlands

    Site Not Available

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