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Fibrinogen and Bleeding After Cardiac Surgery (Fibro-3)

Primary Purpose

Complications, Bleeding, Coronary Artery Disease

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Fibrinogen
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Complications focused on measuring Fibrinogen, Postoperative bleeding, Transfusions, CABG

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Clopidogrel and warfarin are withdrawn at least 24 hours before surgery.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

Sites / Locations

  • Cardiothoracic Surgery unit, Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Study drug

Arm Description

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

Fibrinogen 2g in 100 ml sterile water given during 15 minutes after anestesiainduction before surgery start

Outcomes

Primary Outcome Measures

To evaluate safety of prophylactic fibrinogen infusion in patients with fibrinogen levels in the lower normal range undergoing cardiac surgery
Blood loss first 12 postoperative hours

Secondary Outcome Measures

Transfusions
Biomarkers of coagulation, fibrinolysis and platelet function
Pharmcoeconomic analysis

Full Information

First Posted
August 27, 2009
Last Updated
May 19, 2015
Sponsor
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT00968045
Brief Title
Fibrinogen and Bleeding After Cardiac Surgery
Acronym
Fibro-3
Official Title
Fibrinogen and Bleeding After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications, Bleeding, Coronary Artery Disease
Keywords
Fibrinogen, Postoperative bleeding, Transfusions, CABG

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
100 ml infusion of saline is given during 15 minutes after anesthesia induction before start of surgery.
Arm Title
Study drug
Arm Type
Experimental
Arm Description
Fibrinogen 2g in 100 ml sterile water given during 15 minutes after anestesiainduction before surgery start
Intervention Type
Drug
Intervention Name(s)
Fibrinogen
Other Intervention Name(s)
Riastap, Haemocomplettan
Intervention Description
Fibrinogen 2 gr in 100 ml sterile water. The infusion is given during 15 minutes
Primary Outcome Measure Information:
Title
To evaluate safety of prophylactic fibrinogen infusion in patients with fibrinogen levels in the lower normal range undergoing cardiac surgery
Time Frame
2 years
Title
Blood loss first 12 postoperative hours
Time Frame
12h
Secondary Outcome Measure Information:
Title
Transfusions
Time Frame
7 days
Title
Biomarkers of coagulation, fibrinolysis and platelet function
Time Frame
7 days
Title
Pharmcoeconomic analysis
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Jeppsson, MD, PhD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiothoracic Surgery unit, Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
26577034
Citation
Jeppsson A, Walden K, Roman-Emanuel C, Thimour-Bergstrom L, Karlsson M. Preoperative supplementation with fibrinogen concentrate in cardiac surgery: A randomized controlled study. Br J Anaesth. 2016 Feb;116(2):208-14. doi: 10.1093/bja/aev367. Epub 2015 Nov 17.
Results Reference
derived

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Fibrinogen and Bleeding After Cardiac Surgery

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