Skip to main content
OpenTrials
Completed

NCT Number: NCT00968045

Fibrinogen and Bleeding After Cardiac Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Complications Arterial Occlusive Diseases Arteriosclerosis Bleeding Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Hemorrhage Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cardiothoracic Surgery unit, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 Clopidogrel and warfarin are withdrawn at least 24 hours before surgery.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

Treatment and study plan

Fibrinogen

Drug

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

Other names: Riastap, Haemocomplettan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Acronym: Fibro-3

Important dates

Study start
2009
Primary completion
2012
Study completion
2015
First posted
Aug 28, 2009
Registry last updated
May 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.