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Fibrinogen and Bleeding After Cardiac Surgery (Fibro-3)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00968045
First Posted: August 28, 2009
Last Update Posted: May 20, 2015
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.
Information provided by (Responsible Party):
Anders Jeppssons, Sahlgrenska University Hospital, Sweden
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Fibrinogen and Bleeding After Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Anders Jeppssons, 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 ]
  • Blood loss first 12 postoperative hours [ Time Frame: 12h ]

Secondary Outcome Measures:
  • Transfusions [ Time Frame: 7 days ]
  • Biomarkers of coagulation, fibrinolysis and platelet function [ Time Frame: 7 days ]
  • Pharmcoeconomic analysis [ Time Frame: 2 years ]

Enrollment: 52
Study Start Date: April 2009
Study Completion Date: May 2015
Primary Completion Date: February 2012 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00968045


Locations
Sweden
Cardiothoracic Surgery unit, Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
Principal Investigator: Anders Jeppsson, MD, PhD Sahlgrenska University Hospital, Sweden
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: August 27, 2009
First Posted: August 28, 2009
Last Update Posted: May 20, 2015
Last Verified: May 2015

Keywords provided by Anders Jeppssons, 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