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Fibrinogen and Bleeding After Cardiac Surgery (Fibro-3)

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ClinicalTrials.gov Identifier: NCT00968045
Recruitment Status : Completed
First Posted : August 28, 2009
Last Update Posted : May 20, 2015
Sponsor:
Information provided by (Responsible Party):
Anders Jeppssons, Sahlgrenska University Hospital, Sweden

Brief Summary:
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 or disease Intervention/treatment Phase
Complications Bleeding Coronary Artery Disease Drug: Fibrinogen Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
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
Study Start Date : April 2009
Actual Primary Completion Date : February 2012
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Fibrinogen

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. To evaluate safety of prophylactic fibrinogen infusion in patients with fibrinogen levels in the lower normal range undergoing cardiac surgery [ Time Frame: 2 years ]
  2. Blood loss first 12 postoperative hours [ Time Frame: 12h ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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 Posted: August 28, 2009    Key Record Dates
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:
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Coronary Artery Disease
Hemorrhage
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes