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Haemocomplettan® P During Elective Complex Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 10, 2010
First Posted Date  ICMJE May 18, 2010
Last Update Posted Date December 16, 2014
Study Start Date  ICMJE February 2011
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01124981 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2010)
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Haemocomplettan® P During Elective Complex Cardiac Surgery
Official Title  ICMJE Efficacy and Safety of Haemocomplettan® P in Patients Experiencing Microvascular Bleeding While Undergoing Elective Complex Cardiac Surgery
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Fibrinogen Deficiency in Complex Cardiac Surgery
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Albumin
    Intervention: Drug: Human albumin (Placebo)
  • Experimental: Haemocomplettan® P
    Intervention: Drug: Haemocomplettan® P
Publications * Bilecen S, de Groot JA, Kalkman CJ, Spanjersberg AJ, Brandon Bravo Bruinsma GJ, Moons KG, Nierich AP. Effect of Fibrinogen Concentrate on Intraoperative Blood Loss Among Patients With Intraoperative Bleeding During High-Risk Cardiac Surgery: A Randomized Clinical Trial. JAMA. 2017 Feb 21;317(7):738-747. doi: 10.1001/jama.2016.21037.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 17, 2010)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01124981
Other Study ID Numbers  ICMJE BI1401_2010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arno P. Nierich, Isala
Study Sponsor  ICMJE Isala
Collaborators  ICMJE CSL Behring
Investigators  ICMJE
Principal Investigator: Arno P Nierich, MD, PhD. Isala
PRS Account Isala
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP