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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


- candidate number3610
- NTR NumberNTR1386
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-jul-2008
- Secondary IDsNL21390.058.08 
- Public TitleThe 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
- Scientific TitleThe 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
- ACRONYMFIBER
- hypothesisThe use of Fibrin Sealant (FS) in CABG surgery will reduce the amount of transfusions required within 48 hrs after surgery as well as the length of ICU stay.
- Healt Condition(s) or Problem(s) studiedCoronary Artery Bypass Grafting (CABG), Blood transfusions, Cost-effectiveness , Randomized Controlled Trial (RCT), Fibrin sealant
- Inclusion criteria1. Elective, isolated CABG surgery with the use of at least one internal thoracic artery
2. Age >18 years
- Exclusion criteria1. 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blinding[default]
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-sep-2008
- planned closingdate15-sep-2010
- Target number of participants1500
- InterventionsPatients are randomly assigned to receive either FS treatment, up to a maximum of 15 ml FS per patient, or no FS treatment
- Primary outcomeEfficacy:
Total amount of blood products used within 48 hrs after surgery
Costs:
Length of ICU stay
- Secondary outcomeEfficacy:
- Blood loss
- Reoperation for bleeding
- Wound infection
- Mortality
Costs:
- Length of hospital stay
- Timepoints- First 48 hrs after surgery
- End ICU stay
- Discharge
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD, PhD G. Tavilla
- CONTACT for SCIENTIFIC QUERIESMD, PhD G. Tavilla
- Sponsor/Initiator Sanquin Blood Bank (Stichting Sanquin Bloedvoorziening)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Sanquin Blood Supply
- PublicationsN/A
- Brief summary
- Main changes (audit trail)
- RECORD10-jul-2008 - 4-aug-2008


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