Haemocomplettan® P During Elective Complex Cardiac Surgery

This study is currently recruiting participants.
Verified December 2013 by Isala Klinieken
Sponsor:
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Arno P. Nierich, Isala Klinieken
ClinicalTrials.gov Identifier:
NCT01124981
First received: May 10, 2010
Last updated: December 31, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Fibrinogen Deficiency in Complex Cardiac Surgery
Drug: Haemocomplettan® P
Drug: Human albumin (Placebo)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Haemocomplettan® P in Patients Experiencing Microvascular Bleeding While Undergoing Elective Complex Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Isala Klinieken:

Primary Outcome Measures:
  • To determine whether fibrinogen concentrate infusion reduces perioperative blood loss. [ Time Frame: within 12 hours. ] [ Designated as safety issue: No ]
    Perioperative blood loss measured as blood loss in ml between infusion of study medication and closure of chest.


Secondary Outcome Measures:
  • To determine whether fibrinogen concentrate infusion reduces postoperative blood loss. [ Time Frame: within 24 hours after infusion of study medication. ] [ Designated as safety issue: No ]
    Postoperative blood loss, measured as blood loss at the ICU between closure of chest and 1st hour, 6th hour and after 24 hours.

  • To determine whether fibrinogen concentrate infusion reduces postoperative transfusion of blood products during elective complex cardiac surgery. [ Time Frame: within 24 hours after infusion of study medication. ] [ Designated as safety issue: No ]
    Number of units red blood cell concentrate, fresh frozen plasma and platelet concentrate administered within 24 hours after closure of chest.

  • To determine whether fibrinogen concentrate infusion is safe and well-tolerated. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Major clinical events: Mortality at 30 days post-surgery, MACE (major adverse cardiac event), cerebrovascular accident/ transient ischemic attack, renal insufficiency or failure, venous thromboembolism/ pulmonary embolism, allergic or other systemic reaction to study medication


Estimated Enrollment: 120
Study Start Date: February 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Albumin Drug: Human albumin (Placebo)
Human albumin with concentration 200g/L. The study bottles of 50 mL will be diluted with saline and will contain 2g in total. This concentration resembles the total protein load in the bottles with Haemocomplettan® P.
Other Name: Albumin
Experimental: Haemocomplettan® P Drug: Haemocomplettan® P
Dosing of study medication will be individually determined based on plasma fibrinogen concentrations (measured with Clauss method during the reperfusion period on CPB) and body weight. Intravenous infusion within 10 minutes.
Other Names:
  • Haemocomplettan® P
  • Fibrinogen concentrate

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124981

Contacts
Contact: Marga Hoogendoorn, Msc. 003138 424 4245 m.e.hoogendoorn@isala.nl

Locations
Netherlands
Department of Cardiothoracic Anaesthesia and Intensive Care Isala Klinieken Not yet recruiting
Zwolle, Overijssel, Netherlands, 8011 JW
Contact: Marga E Hoogendoorn, Msc.    003138 424 4245    m.e.hoogendoorn@isala.nl   
Department Anesthesiology & Intensive Care Recruiting
Zwolle, Overijssel, Netherlands, 8011 JW
Contact: Marga Hoogendoorn, Drs.    +31-38-4244245    m.e.hoogendoorn@isala.nl   
Sponsors and Collaborators
Isala Klinieken
CSL Behring
Investigators
Principal Investigator: Arno P Nierich, MD, PhD. Isala Klinieken Zwolle
  More Information

Additional Information:
No publications provided

Responsible Party: Arno P. Nierich, MD, PhD, Isala Klinieken
ClinicalTrials.gov Identifier: NCT01124981     History of Changes
Other Study ID Numbers: BI1401_2010
Study First Received: May 10, 2010
Last Updated: December 31, 2013
Health Authority: The Netherlands: Centrale Commissie Mensgebonden Onderzoek (CCMO). METC Zwolle.

Keywords provided by Isala Klinieken:
Fibrinogen concentrate
Coagulopathy

Additional relevant MeSH terms:
Afibrinogenemia
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on April 16, 2014