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Fibrinogen and Bleeding After Cardiac Surgery (Fibro-3)

This study is currently recruiting participants.
Verified December 2012 by Sahlgrenska University Hospital, Sweden
Sponsor:
Information provided by (Responsible Party):
Anders Jeppssons, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT00968045
First received: August 27, 2009
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

The study hypothesis is that prophylactic fibrinogen infusion reduces postoperative bleeding and transfusion requirements after coronary artery bypass surgery (CABG) in patients with endogenous fibrinogen levels in the lower normal range. 60 patients will be included in a prospective, randomized double-blind placebo-controlled single center study.


Condition Intervention Phase
Complications
Bleeding
Coronary Artery Disease
 Drug: Fibrinogen
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Fibrinogen and Bleeding After Cardiac Surgery

Resource links provided by NLM:

Drug Information available for: Fibrinogen
U.S. FDA Resources

Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • To evaluate safety of prophylactic fibrinogen infusion in patients with fibrinogen levels in the lower normal range undergoing cardiac surgery [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Blood loss first 12 postoperative hours [ Time Frame: 12h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Transfusions [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Biomarkers of coagulation, fibrinolysis and platelet function [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Pharmcoeconomic analysis [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2009
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
100 ml infusion of saline is given during 15 minutes after anesthesia induction before start of surgery.
 Drug: Fibrinogen
Fibrinogen 2 gr in 100 ml sterile water. The infusion is given during 15 minutes
Other Names:
  • Riastap
  • Haemocomplettan
Experimental: Study drug
Fibrinogen 2g in 100 ml sterile water given during 15 minutes after anestesiainduction before surgery start
 Drug: Fibrinogen
Fibrinogen 2 gr in 100 ml sterile water. The infusion is given during 15 minutes
Other Names:
  • Riastap
  • Haemocomplettan

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and Females
  • Age 18 years and above
  • Patients eligible for a first-time coronary artery bypass(CABG) surgery with a preoperative fibrinogen plasma concentration under 3,8 g/L
  • Signed informed consent to participate in the study

Exclusion Criteria:

  • Patients undergoing redo surgery
  • Clinical or laboratory signs of bleeding disorder
  • Clinical or laboratory signs of significant liver disease, or,other significant disease or condition which in the investigators judgment interfere with hemostasis
  • Any medications with agents which may interfere with hemostasis within 14 days prior to study start. Clopidogrel and warfarin are withdrawn at least 24 hours before surgery. Oral aspirin is allowed co-medication.
  • Administration of other investigational drugs within eight weeks preceding the preentry examination
  • Pregnant or lactating women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968045

Contacts
Contact: Anders Jeppsson, MD, PhD 0046313427515 anders.jeppsson@vgregion.se
Contact: Christine Roman-Emanuel, RN 0046313428757 christine.roman-emanuel@vgregion.se

Locations
Sweden
Cardiothoracic Surgery unit, Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, 41345
Contact: Anders Jeppsson, MD, PhD     0046313427515     anders.jeppsson@vgregion.se    
Contact: Christine Emanuel, RN     0046313428757     christine.roman-emanuel@vgregion.se    
Principal Investigator: Anders Jeppsson, MD PhD            
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
Principal Investigator: Anders Jeppsson, MD, PhD Sahlgrenska University Hospital, Sweden
  More Information

No publications provided

Responsible Party: Anders Jeppssons, Professor, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT00968045     History of Changes
Other Study ID Numbers: Fibro 01/07, EudraCT-nr:2007-007157-31
Study First Received: August 27, 2009
Last Updated: December 19, 2012
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

Keywords provided by Sahlgrenska University Hospital, Sweden:
Fibrinogen
Postoperative bleeding
Transfusions
CABG

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hemorrhage
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013