Proximal Aortic DissectionPhase 2SEFCNCT02542306
Safety and Efficacy of Fibrinogen Concentrate in Aortic Arch Surgery Involving Moderate Hypothermic Circulatory Arrest
A Phase 2 study testing fibrinogen concentrate in people with Proximal Aortic Dissection, run by Hongjia Zhang at 1 site in China.
Trial summary
Bleeding is a common complication of cardiac surgery, especially aortic arch surgery involving moderate hypothermic circulatory arrest. Fibrinogen concentrate is increasingly used to treat coagulopathic bleeding in cardiac surgery, although its effectiveness and safety are unknown. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Proximal Aortic Dissection
- What is being tested?
- fibrinogen concentrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to Aug 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participants aged 18 years or above who were undergoing emergency aortic arch surgery involving moderate hypothermic circulatory arrest for an acute type A aortic dissection
Who cannot join
- The participants with congenital or acquired coagulation disorders, previous surgery at the same site, death prior to planned surgery, stroke or myocardial infarction within 2 months before surgery and use of aspirin, clopidogrel or vitamin K antagonists within 2 to 5 days before surgery.
Trial locations and contacts
1 site in 1 country.
Hongjia Zhang, M.D. contact
Xinliang Guan, M.D. contact
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Hongjia Zhang, M.D.
Xinliang Guan
About this study
Bleeding is a common complication of cardiac surgery, especially aortic arch surgery involving moderate hypothermic circulatory arrest. Fibrinogen concentrate is increasingly used to treat coagulopathic bleeding in cardiac surgery, although its effectiveness and safety are unknown.
Fibrinogen concentrate was administered to 54 patients when the fibrinogen level was below 1.5 g/L after protamine reversal. Additionally, 30 patients were enrolled as the non-FC-treated group.
Read the detailed description
The aim of this prospective study was to investigate the safety and efficacy of fibrinogen concentrate in patients with acute type A aortic dissection.
Eighty-four acute type A aortic dissection patients undergoing emergency aortic arch surgery involving moderate hypothermic circulatory arrest were included. The clinical data, standard laboratory tests and plasma fibrinogen levels were obtained at 5 time points.
The investigators analyzed the standard laboratory tests, the plasma fibrinogen levels, the volumes of cumulative postoperative drainage and transfused allogenic blood products in 84 patients.
The primary and secondary end points were determined and considered.The primary endpoint (efficacy endpoint) included the volumes of individual allogeneic blood products, volumes of cumulative drainage within 24 h and 48 h and 5 days volumes after infusion of fibrinogen concentrate as well as the rates of reoperation due to bleeding. The secondary endpoint (safety endpoint) for the study was the incidence of serious adverse events from infusion of fibrinogen concentrate to day 45. The serious adverse events defined for the evaluation of safety of fibrinogen concentrate were death, pulmonary embolism and other thromboembolic or ischemic events (myocardial infarction, paraplegia and cerebral infarction).
- Conditions
- Proximal Aortic Dissection
- Being tested
- fibrinogen concentrate
- Keywords
- Blood loss, coagulopathy, fibrinogen concentrate, transfusion
- Medical subject headings
- Hemorrhage, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fibrinogen concentrateDrug
Investigators administered fibrinogen concentrate when the plasma fibrinogen level was below 1.5 g/L at 5 minutes after protamine reversal and completion of surgical hemostasis in patients, who comprised the fibrinogen concentrate-treated group.
| Study group | Role | What they receive |
|---|---|---|
| fibrinogen concentrate-treated group | Experimental | The initial fibrinogen concentrate dose was 25 - 50 mg/kg, but additional fibrinogen concentrate was administered repeatedly if the first infusion of fibrinogen concentrate did not increase the fibrinogen level over 2.0 g/L. Receives: Drug: fibrinogen concentrate |
| non-fibrinogen concentrate-treated group | No intervention | The participants who did not received fibrinogen concentrate treatment were enrolled as the non-fibrinogen concentrate-treated group |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy endpoint (the volumes of allogeneic blood products, volumes of cumulative drainage within 24 h and 48 h and 5 days
Investigators hypothesized that the hemostatic therapy with fibrinogen concentrate in acute type A aortic dissection patients resulted in a reduction in the transfusion of allogeneic blood products and drainage volumes compared to the control group that received conventional hemostatic therapy.
Measured: from the time of fibrinogen concentrate administration until the 5th postoperative day
Secondary outcomes (1)
safety endpoint (incidence of serious adverse events)
The serious adverse events defined for the evaluation of safety of fibrinogen concentrate were death, pulmonary embolism and other thromboembolic or ischemic events (myocardial infarction, paraplegia and cerebral infarction).
Measured: from infusion of fibrinogen concentrate to day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startJul 2013
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Aortic DissectionStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hongjia Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Anzhen Hospital
- Responsible party
- Sponsor-investigator, Hongjia Zhang, Beijing Municipal Science & Technology Commission
- Investigators
- Hongjia Zhang, M.D., Study chair, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542306
- Sponsor's protocol ID
- Z141100002114025
- Acronym
- SEFC
- Status last verified
- Sep 2015
- First submitted
- 25 Aug 2015
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Fibrinogen Concentrate in Aortic Arch Surgery Involving Moderate Hypothermic Circulatory Arrest
- ClinicalTrials.gov ID
- NCT02542306
- Acronym / sponsor ID
- SEFC / Z141100002114025
- Conditions
- Proximal Aortic Dissection
- Keywords
- Blood loss, coagulopathy, fibrinogen concentrate, transfusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hongjia ZhangUniversity, hospital or other
- Collaborators
- Beijing Anzhen Hospital
- Study start
- Jul 2013
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 7 Sep 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.
Bleeding is a common complication of cardiac surgery, especially aortic arch surgery involving moderate hypothermic circulatory arrest. Fibrinogen concentrate is increasingly used to treat coagulopathic bleeding in cardiac surgery, although its effectiveness and safety are unknown.
Fibrinogen concentrate was administered to 54 patients when the fibrinogen level was below 1.5 g/L after protamine reversal. Additionally, 30 patients were enrolled as the non-FC-treated group.
Detailed description
The aim of this prospective study was to investigate the safety and efficacy of fibrinogen concentrate in patients with acute type A aortic dissection.
Eighty-four acute type A aortic dissection patients undergoing emergency aortic arch surgery involving moderate hypothermic circulatory arrest were included. The clinical data, standard laboratory tests and plasma fibrinogen levels were obtained at 5 time points.
The investigators analyzed the standard laboratory tests, the plasma fibrinogen levels, the volumes of cumulative postoperative drainage and transfused allogenic blood products in 84 patients.
The primary and secondary end points were determined and considered.The primary endpoint (efficacy endpoint) included the volumes of individual allogeneic blood products, volumes of cumulative drainage within 24 h and 48 h and 5 days volumes after infusion of fibrinogen concentrate as well as the rates of reoperation due to bleeding. The secondary endpoint (safety endpoint) for the study was the incidence of serious adverse events from infusion of fibrinogen concentrate to day 45. The serious adverse events defined for the evaluation of safety of fibrinogen concentrate were death, pulmonary embolism and other thromboembolic or ischemic events (myocardial infarction, paraplegia and cerebral infarction).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fibrinogen concentrate-treated group | Experimental | Drug: fibrinogen concentrateThe initial fibrinogen concentrate dose was 25 - 50 mg/kg, but additional fibrinogen concentrate was administered repeatedly if the first infusion of fibrinogen concentrate did not increase the fibrinogen level over 2.0 g/L. |
| non-fibrinogen concentrate-treated group | No intervention | –The participants who did not received fibrinogen concentrate treatment were enrolled as the non-fibrinogen concentrate-treated group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The participants aged 18 years or above who were undergoing emergency aortic arch surgery involving moderate hypothermic circulatory arrest for an acute type A aortic dissection
Key exclusion criteria (1 listed)
- The participants with congenital or acquired coagulation disorders, previous surgery at the same site, death prior to planned surgery, stroke or myocardial infarction within 2 months before surgery and use of aspirin, clopidogrel or vitamin K antagonists within 2 to 5 days before surgery.
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 concentrateInvestigators administered fibrinogen concentrate when the plasma fibrinogen level was below 1.5 g/L at 5 minutes after protamine reversal and completion of surgical hemostasis in patients, who comprised the fibrinogen concentrate-treated group. | Drug | fibrinogen concentrate-treated group |
Primary outcome
efficacy endpoint (the volumes of allogeneic blood products, volumes of cumulative drainage within 24 h and 48 h and 5 days
Time frame: from the time of fibrinogen concentrate administration until the 5th postoperative day
Investigators hypothesized that the hemostatic therapy with fibrinogen concentrate in acute type A aortic dissection patients resulted in a reduction in the transfusion of allogeneic blood products and drainage volumes compared to the control group that received conventional hemostatic therapy.
1 secondary outcome
safety endpoint (incidence of serious adverse events)
Time frame: from infusion of fibrinogen concentrate to day 45
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
Related trials for Proximal Aortic Dissection
Recruiting
Remote Ischemic Preconditioning for Aute Type A Aortic Dissection Surgery
Aortic Dissection Type A
RecruitingPhase 3
Study on Ketorolac for Improving Outcomes and Prognosis in Patients With Stanford Type A Aortic Dissection
Aortic Dissection, Inflammation
RecruitingObservational study
Nordic Consortium for Acute Type A Aortic Dissection-2
Aortic Dissection
Not yet recruiting
sirA-CPB Strategy Reduces New Ischemic/Embolic Lesions After Acute Type A Aortic Dissection Surgery
Dissection, Aortic
Not yet recruiting
AI-Guided Intensified Follow-up After Surgery for Acute Type A Aortic Dissection
Acute Type A Aortic Dissection, Stanford Type A Aortic Dissection
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.
Hongjia Zhang, M.D. contact
Xinliang Guan, M.D. contact
Hongjia Zhang, M.D. study chair
Beijing Anzhen 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 concentrate in people with Proximal Aortic Dissection, run by Hongjia Zhang at 1 site in China.
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 1 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: status not confirmed, as of the sponsor's last update on 7 Sep 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 China. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongjia Zhang, M.D. (hongjia722@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy endpoint (the volumes of allogeneic blood products, volumes of cumulative drainage within 24 h and 48 h and 5 days (time frame: from the time of fibrinogen concentrate administration until the 5th postoperative day). 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 7 Sep 2015.