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Haemocomplettan® P During Elective Complex Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT01124981
Recruitment Status : Completed
First Posted : May 18, 2010
Last Update Posted : December 16, 2014
Sponsor:
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Arno P. Nierich, Isala

Study Description
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Brief 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.

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

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Fibrinogen

Arms and Interventions
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Arm Intervention/treatment
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 Name: Fibrinogen concentrate


Outcome Measures
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Primary Outcome Measures :
  1. To determine whether fibrinogen concentrate infusion reduces perioperative blood loss. [ Time Frame: within 12 hours. ]
    Perioperative blood loss measured as blood loss in ml between infusion of study medication and closure of chest.


Secondary Outcome Measures :
  1. To determine whether fibrinogen concentrate infusion reduces postoperative blood loss. [ Time Frame: within 24 hours after infusion of study medication. ]
    Postoperative blood loss, measured as blood loss at the ICU between closure of chest and 1st hour, 6th hour and after 24 hours.

  2. 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. ]
    Number of units red blood cell concentrate, fresh frozen plasma and platelet concentrate administered within 24 hours after closure of chest.

  3. To determine whether fibrinogen concentrate infusion is safe and well-tolerated. [ Time Frame: 30 days ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01124981


Locations
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Netherlands
Department Anesthesiology & Intensive Care
Zwolle, Overijssel, Netherlands, 8011 JW
Department of Cardiothoracic Anaesthesia and Intensive Care Isala Klinieken
Zwolle, Overijssel, Netherlands, 8011 JW
Sponsors and Collaborators
Isala
CSL Behring
Investigators
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Principal Investigator: Arno P Nierich, MD, PhD. Isala
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Arno P. Nierich, MD, PhD, Isala
ClinicalTrials.gov Identifier: NCT01124981     History of Changes
Other Study ID Numbers: BI1401_2010
First Posted: May 18, 2010    Key Record Dates
Last Update Posted: December 16, 2014
Last Verified: December 2014
Keywords provided by Arno P. Nierich, Isala:
Fibrinogen concentrate
Coagulopathy
Additional relevant MeSH terms:
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Afibrinogenemia
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
 Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn