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

Tracking Information

First Received Date ^ICMJE

August 27, 2009

Last Updated Date

December 19, 2012

Start Date ^ICMJE

April 2009

Estimated Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

To confirm the safety and efficacy 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 ]

Change History

Complete list of historical versions of study NCT00968045 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Effects of fibrinogen on bleeding volume after surgery, postoperative haemoglobin levels 12 and 24 h after surgery, pharmacoeconomic effects, and effects of fibrinogen infusions on laboratory variables [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Fibrinogen and Bleeding After Cardiac Surgery

Official Title ^ICMJE

Fibrinogen and Bleeding After Cardiac Surgery

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Complications
Bleeding
Coronary Artery Disease

Intervention ^ICMJE

Drug: Fibrinogen

Fibrinogen 2 gr in 100 ml sterile water. The infusion is given during 15 minutes

Other Names:

Riastap
Haemocomplettan

Study Arm (s)

Placebo Comparator: Placebo
100 ml infusion of saline is given during 15 minutes after anesthesia induction before start of surgery.

Intervention: Drug: Fibrinogen
Experimental: Study drug
Fibrinogen 2g in 100 ml sterile water given during 15 minutes after anestesiainduction before surgery start

Intervention: Drug: Fibrinogen

Publications *

Not Provided

* 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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2013

Estimated Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Sweden

Administrative Information

NCT Number ^ICMJE

NCT00968045

Other Study ID Numbers ^ICMJE

Fibro 01/07, EudraCT-nr:2007-007157-31

Has Data Monitoring Committee

Yes

Responsible Party

Anders Jeppssons, Sahlgrenska University Hospital, Sweden

Study Sponsor ^ICMJE

Sahlgrenska University Hospital, Sweden

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Anders Jeppsson, MD, PhD

Sahlgrenska University Hospital, Sweden

Information Provided By

Sahlgrenska University Hospital, Sweden

Verification Date

December 2012

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

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