NCT00968045

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

2.8 years

First QC Date

August 27, 2009

Last Update Submit

May 19, 2015

Conditions

ComplicationsBleedingCoronary Artery Disease

Keywords

FibrinogenPostoperative bleedingTransfusionsCABG

Outcome Measures

Primary Outcomes (2)

  • To evaluate safety of prophylactic fibrinogen infusion in patients with fibrinogen levels in the lower normal range undergoing cardiac surgery

    2 years

  • Blood loss first 12 postoperative hours

    12h

Secondary Outcomes (3)

  • Transfusions

    7 days

  • Biomarkers of coagulation, fibrinolysis and platelet function

    7 days

  • Pharmcoeconomic analysis

    2 years

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Fibrinogen

Study drug

EXPERIMENTAL

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

Drug: Fibrinogen

Interventions

FibrinogenDRUG

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

Also known as: Riastap, Haemocomplettan
PlaceboStudy drug

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiothoracic Surgery unit, Sahlgrenska University Hospital

Gothenburg, Gothenburg, 41345, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 26577034DERIVED

MeSH Terms

Conditions

HemorrhageCoronary Artery DiseasePostoperative Hemorrhage

Interventions

Fibrinogen

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPostoperative Complications

Intervention Hierarchy (Ancestors)

Acute-Phase ProteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBlood Coagulation FactorsProtein PrecursorsBiological Factors

Study Officials

  • Anders Jeppsson, MD, PhD

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 27, 2009

First Posted

August 28, 2009

Study Start

April 1, 2009

Primary Completion

February 1, 2012

Study Completion

May 1, 2015

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations

SE(1)