The Fibrin Induced Blood Exposure Reduction (FIBER) Study: A multi-center, randomized controlled clinical trial to investigate the cost-effectiveness of Fibrin Sealant in CABG surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28163

Enrollment

1500

Registered

2008-07-10

Start date

2008-09-15

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibrin Sealant CABG surgery blood transfusion cost-effectiveness

Interventions

Patients are randomly assigned to receive either FS treatment, up to a maximum of 15 ml FS per patient, or no FS treatment

Eligibility

Inclusion criteria

Inclusion criteria: 1. Elective, isolated CABG surgery with the use of at least one internal thoracic artery 2. Age >18 years

Exclusion criteria

Exclusion criteria: 1. Exclusive use of venous grafts 2. Any concomitant procedure, including AF ablation 3. Emergency surgery 4. History of bleeding diathesis or coagulopathy 5. Jehova’s witness 6. Participation in any study involving an investigational drug or device

Design outcomes

Primary

Measure	Time frame
Efficacy: Total amount of blood products used within 48 hrs after surgery Costs: Length of ICU stay	—

Secondary

Measure	Time frame
Efficacy: - Blood loss - Reoperation for bleeding - Wound infection - Mortality Costs: - Length of hospital stay	—

Contacts

Public ContactG. Tavilla

Leiden University Medical Center Department of Cardiothoracic Surgery PO Box 9600

G.Tavilla@lumc.nl+31 (0)71 5264022

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)