Fibrinogens, AbnormalNCT02605330
Kinetics of Plasma Fibrinogen in Cardiac Surgery
An observational study of Fibrinogens, Abnormal, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The study intends to measure fibrinogen plasma levels during the first 24 hrs in cardiac and thoracic surgical patients who undergo surgical procedures using extracorporeal circulation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Fibrinogens, Abnormal
- What is being tested?
- Fibrinogen plasma level
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2015to 14 Sep 2017
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cardiac surgery with extracorporeal bypass
Who may be able to join
- Elective patients undergoing coronary artery bypass grafting, aortic valve replacement or thoracic aortic surgery
- Signed written informed consent
Who cannot join
- Participation in another study
- Language barrier to understand study purposes (e.g. french as a native language)
- Preoperative low level of plasma fibrinogen (< 1.75 g/l)
- Preoperative anemia (Hb < 10g/dl)
- Emergency treatment
- Intake of anticoagulants other than aspirin within 14 days preceding surgery.
- Known coagulation disorder.
- Jehovah's witnesses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kinetics of Plasma Fibrinogen During Cardiac and Thoracic Aortic Surgery
The study intends to measure fibrinogen plasma levels during the first 24 hrs in cardiac and thoracic surgical patients who undergo surgical procedures using extracorporeal circulation.
- Conditions
- Fibrinogens, Abnormal
- Being tested
- Fibrinogen plasma level
- Medical subject headings
- Antisocial Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrinogen plasma levelProcedure or surgery
At 12 different time points investigators plan to measure the plasma fibrinogen level with conventional coagulation tests (Clauss fibrinogen) and with ROTEM.
| Study group | Role | What they receive |
|---|---|---|
| Fibrinogen plasma level in CABG | In all patients undergoing coronary artery bypass grafting (CABG) the investigators plan to measure the fibrinogen plasma level Receives: Procedure: Fibrinogen plasma level | |
| Fibrinogen plasma level in AVR | In all patients undergoing aortic valve replacement (AVR) the investigators plan to measure the fibrinogen plasma level Receives: Procedure: Fibrinogen plasma level | |
| Fibrinogen plasma level in AAR | In all patients undergoing aortic arch replacement (AAR) the investigators plan to measure the fibrinogen plasma level Receives: Procedure: Fibrinogen plasma level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma fibrinogen concentration
Conventional (Clauss) and thromboelastometric measurement (FIBTEM)
Measured: through study completion, an average of 1 year
Secondary outcomes (9)
Periprocedural thromboembolic complications
Measured: through study completion, an average of 1 year
Thoracic drain loss
Measurement of the amount of blood collected by the thoracic drain (ml)
Measured: through study completion, an average of 1 year
In-hospital mortality
Measured: through study completion, an average of 1 year
Intensive Care Unit (ICU) length of stay
Measured: through study completion, an average of 1 year
Platelet count
Measurement of platelet count in the laboratory
Measured: through study completion, an average of 1 year
Prothrombin time (Quick)
Measurement of Quick in the laboratory
Measured: through study completion, an average of 1 year
Activated partial thromboplastin time (aPTT)
Measurement of aPTT in the laboratory
Measured: through study completion, an average of 1 year
Thromboelastometric (ROTEM) parameters (e.g., INTEM, EXTEM, HEPTEM)
Measurement of ROTEM parameter (unit mm) in the laboratory
Measured: through study completion, an average of 1 year
Thrombin concentration
Thrombin concentration in the plasma as measured in the laboratory
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2016
- Study completion14 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrinogens, AbnormalStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabor Erdoes, MD, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605330
- Sponsor's protocol ID
- 193/15
- Status last verified
- Sep 2017
- First submitted
- 11 Nov 2015
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetics of Plasma Fibrinogen During Cardiac and Thoracic Aortic Surgery
- ClinicalTrials.gov ID
- NCT02605330
- Acronym / sponsor ID
- 193/15
- Conditions
- Fibrinogens, Abnormal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- 14 Sep 2017 (actual)
- First posted
- 16 Nov 2015 (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 intends to measure fibrinogen plasma levels during the first 24 hrs in cardiac and thoracic surgical patients who undergo surgical procedures using extracorporeal circulation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fibrinogen plasma level in CABG | – | Procedure: Fibrinogen plasma levelIn all patients undergoing coronary artery bypass grafting (CABG) the investigators plan to measure the fibrinogen plasma level |
| Fibrinogen plasma level in AVR | – | Procedure: Fibrinogen plasma levelIn all patients undergoing aortic valve replacement (AVR) the investigators plan to measure the fibrinogen plasma level |
| Fibrinogen plasma level in AAR | – | Procedure: Fibrinogen plasma levelIn all patients undergoing aortic arch replacement (AAR) the investigators plan to measure the fibrinogen plasma level |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac surgery with extracorporeal bypass
Key inclusion criteria (2 listed)
- Elective patients undergoing coronary artery bypass grafting, aortic valve replacement or thoracic aortic surgery
- Signed written informed consent
Key exclusion criteria (8 listed)
- Participation in another study
- Language barrier to understand study purposes (e.g. french as a native language)
- Preoperative low level of plasma fibrinogen (< 1.75 g/l)
- Preoperative anemia (Hb < 10g/dl)
- Emergency treatment
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 |
|---|---|---|
| Fibrinogen plasma levelAt 12 different time points investigators plan to measure the plasma fibrinogen level with conventional coagulation tests (Clauss fibrinogen) and with ROTEM. | Procedure or surgery | Fibrinogen plasma level in AAR, Fibrinogen plasma level in AVR, Fibrinogen plasma level in CABG |
Primary outcome
Plasma fibrinogen concentration
Time frame: through study completion, an average of 1 year
Conventional (Clauss) and thromboelastometric measurement (FIBTEM)
9 secondary outcomes
Periprocedural thromboembolic complications
Time frame: through study completion, an average of 1 year
Thoracic drain loss
Time frame: through study completion, an average of 1 year
In-hospital mortality
Time frame: through study completion, an average of 1 year
Intensive Care Unit (ICU) length of stay
Time frame: through study completion, an average of 1 year
Platelet count
Time frame: through study completion, an average of 1 year
Prothrombin time (Quick)
Time frame: through study completion, an average of 1 year
Activated partial thromboplastin time (aPTT)
Time frame: through study completion, an average of 1 year
Thromboelastometric (ROTEM) parameters (e.g., INTEM, EXTEM, HEPTEM)
Time frame: through study completion, an average of 1 year
Thrombin concentration
Time frame: through study completion, an average of 1 year
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 18 Sep 2017.
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.
Gabor Erdoes, MD principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibrinogens, Abnormal, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 2 inclusion and 8 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 18 Sep 2017. 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 Switzerland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Plasma fibrinogen concentration (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2017.