ComplicationsPhase 2Fibro-3NCT00968045
Fibrinogen and Bleeding After Cardiac Surgery
A Phase 2 study testing Fibrinogen in people with Complications and Bleeding, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Complications, Bleeding, Coronary Artery Disease
- What is being tested?
- Fibrinogen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2009to May 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 Clopidogrel and warfarin are withdrawn at least 24 hours before surgery.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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Cardiothoracic Surgery unit, Sahlgrenska University Hospital
Gothenburg, Gothenburg, 41345
About this study
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.
- Conditions
- Complications, Bleeding, Coronary Artery Disease
- Being tested
- Fibrinogen
- Keywords
- Fibrinogen, Postoperative bleeding, Transfusions, CABG
- Medical subject headings
- Hemorrhage, Coronary Artery Disease, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibrinogenDrug
Also called Riastap, Haemocomplettan
Fibrinogen 2 gr in 100 ml sterile water. The infusion is given during 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 100 ml infusion of saline is given during 15 minutes after anesthesia induction before start of surgery. Receives: Drug: Fibrinogen |
| Study drug | Experimental | Fibrinogen 2g in 100 ml sterile water given during 15 minutes after anestesiainduction before surgery start Receives: Drug: Fibrinogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate safety of prophylactic fibrinogen infusion in patients with fibrinogen levels in the lower normal range undergoing cardiac surgery
Measured: 2 years
Blood loss first 12 postoperative hours
Measured: 12h
Secondary outcomes (3)
Transfusions
Measured: 7 days
Biomarkers of coagulation, fibrinolysis and platelet function
Measured: 7 days
Pharmcoeconomic analysis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startApr 2009
- Primary completionFeb 2012
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Jeppssons, Sahlgrenska University Hospital
- Investigators
- Anders Jeppsson, MD, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968045
- Sponsor's protocol ID
- Fibro 01/07
- Other IDs
- EudraCT-nr:2007-007157-31
- Acronym
- Fibro-3
- Status last verified
- May 2015
- First submitted
- 27 Aug 2009
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26577034
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibrinogen and Bleeding After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00968045
- Acronym / sponsor ID
- Fibro-3 / Fibro 01/07
- Conditions
- Complications, Bleeding, Coronary Artery Disease
- Keywords
- Fibrinogen, Postoperative bleeding, Transfusions, CABG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 28 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Fibrinogen100 ml infusion of saline is given during 15 minutes after anesthesia induction before start of surgery. |
| Study drug | Experimental | Drug: FibrinogenFibrinogen 2g in 100 ml sterile water given during 15 minutes after anestesiainduction before surgery start |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FibrinogenAlso: Riastap, HaemocomplettanFibrinogen 2 gr in 100 ml sterile water. The infusion is given during 15 minutes | Drug | Placebo, Study drug |
Primary outcome
To evaluate safety of prophylactic fibrinogen infusion in patients with fibrinogen levels in the lower normal range undergoing cardiac surgery
Time frame: 2 years
Blood loss first 12 postoperative hours
Time frame: 12h
3 secondary outcomes
Transfusions
Time frame: 7 days
Biomarkers of coagulation, fibrinolysis and platelet function
Time frame: 7 days
Pharmcoeconomic analysis
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
- Derived from this study: PubMed 26577034Jeppsson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Jeppsson, MD, PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fibrinogen in people with Complications and Bleeding, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate safety of prophylactic fibrinogen infusion in patients with fibrinogen levels in the lower normal range undergoing cardiac surgery (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00968045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2015.