Focus of StudyTEG-FFNCT01992757
Thromboelastography-derived Functional Fibrinogen Levels
An observational study of Focus of Study and Coagulation Status of Cardiac Surgery Patient, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study hopes to determine if thromboelastography-derived functional fibrinogen (TEG-FF or FLEV) levels obtained during the rewarming phase of cardiopulmonary bypass can provide information on coagulation status sooner, allowing for anticipation of post-bypass bleeding and transfusion requirements Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focus of Study, Coagulation Status of Cardiac Surgery Patient, Reducing Excess Blood Transfusion
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Aug 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population for this study will be elective cardiac surgical patients who will be undergoing elective primary cardiac surgery.
Who may be able to join
- Elective cardiac surgery patients who are undergoing primary cardiac surgery
Who cannot join
- Emergency surgery
- Re-operative cardiac surgery
- History of hypercoagulable state as defined in medical record
- Anticoagulated status at time of surgery
- Plasma requirement prior to discontinuation of bypass (alters fibrinogen level)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Comparison of Thromboelastography-derived Functional Fibrinogen Levels During and After Cardiopulmonary Bypass
This study hopes to determine if thromboelastography-derived functional fibrinogen (TEG-FF or FLEV) levels obtained during the rewarming phase of cardiopulmonary bypass can provide information on coagulation status sooner, allowing for anticipation of post-bypass bleeding and transfusion requirements
- Conditions
- Focus of Study, Coagulation Status of Cardiac Surgery Patient, Reducing Excess Blood Transfusion
- Keywords
- functional fibrinogen assay, cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac surgery with cardiopulmary bypass | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Thromboelastography-derived Functional Fibrinogen Level (FLEV)
FLEV values obtained during rewarming while on cardiopulmonary bypass (CPB) were compared to FLEV values obtained immediately after CPB and protamine administration. For all patients included, the mean values for rewarming FLEV and mean values for post-CPB FLEV were obtained. If the mean difference for the two timepoints was not statistically different by t-test, then the primary outcome would demonstrate the value of obtaining a rewarming FLEV sample.
Measured: Change in FLEV from rewarming and after cardiopulmonary bypass
Secondary outcomes (1)
Difference in Clauss Assay and FLEV
This secondary outcome aimed to determine if standard laboratory assays for fibrinogen (Clauss) provided values similar to TEG-based functional fibrinogen (FLEV). The difference between the means at various timepoints is calculated in mg/dL.
Measured: Clauss vs FLEV for rewarming and post-CPB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Focus of StudyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prakash A Patel, MD, Principal investigator, University of Pennsylvania Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992757
- Sponsor's protocol ID
- 818918
- Acronym
- TEG-FF
- Status last verified
- Nov 2017
- First submitted
- 5 Nov 2013
- Last updated
- 3 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Thromboelastography-derived Functional Fibrinogen Levels During and After Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT01992757
- Acronym / sponsor ID
- TEG-FF / 818918
- Conditions
- Focus of Study, Coagulation Status of Cardiac Surgery Patient, Reducing Excess Blood Transfusion
- Keywords
- functional fibrinogen assay, cardiac surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Posted 3 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study hopes to determine if thromboelastography-derived functional fibrinogen (TEG-FF or FLEV) levels obtained during the rewarming phase of cardiopulmonary bypass can provide information on coagulation status sooner, allowing for anticipation of post-bypass bleeding and transfusion requirements
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgery with cardiopulmary bypass | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population for this study will be elective cardiac surgical patients who will be undergoing elective primary cardiac surgery.
Key inclusion criteria (1 listed)
- Elective cardiac surgery patients who are undergoing primary cardiac surgery
Key exclusion criteria (5 listed)
- Emergency surgery
- Re-operative cardiac surgery
- History of hypercoagulable state as defined in medical record
- Anticoagulated status at time of surgery
- Plasma requirement prior to discontinuation of bypass (alters fibrinogen level)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Thromboelastography-derived Functional Fibrinogen Level (FLEV)
Time frame: Change in FLEV from rewarming and after cardiopulmonary bypass
FLEV values obtained during rewarming while on cardiopulmonary bypass (CPB) were compared to FLEV values obtained immediately after CPB and protamine administration. For all patients included, the mean values for rewarming FLEV and mean values for post-CPB FLEV were obtained. If the mean difference for the two timepoints was not statistically different by t-test, then the primary outcome would demonstrate the value of obtaining a rewarming FLEV sample.
1 secondary outcome
Difference in Clauss Assay and FLEV
Time frame: Clauss vs FLEV for rewarming and post-CPB
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Prakash A Patel, MD principal investigator
University of Pennsylvania Hospital
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 Focus of Study and Coagulation Status of Cardiac Surgery Patient, run by University of Pennsylvania at 1 site in United States.
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 1 inclusion and 5 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 3 Oct 2018. 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 United States. 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?
Yes. Results are posted in the registry (first posted 3 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Thromboelastography-derived Functional Fibrinogen Level (FLEV) (time frame: Change in FLEV from rewarming and after cardiopulmonary bypass). 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 3 Oct 2018.