- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02542306
Safety and Efficacy of Fibrinogen Concentrate in Aortic Arch Surgery Involving Moderate Hypothermic Circulatory Arrest (SEFC)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Hongjia Zhang, M.D.
- Email: hongjia722@outlook.com
Study Contact Backup
- Name: Xinliang Guan, M.D.
- Email: guanxl119@outlook.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100029
- Recruiting
- Beijing Anzhen Hospital
-
Contact:
- Hongjia Zhang, M.D.
-
Contact:
- Xinliang Guan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: fibrinogen concentrate-treated group
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.
|
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.
|
No Intervention: non-fibrinogen concentrate-treated group
The participants who did not received fibrinogen concentrate treatment were enrolled as the non-fibrinogen concentrate-treated group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
from the time of fibrinogen concentrate administration until the 5th postoperative day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
safety endpoint (incidence of serious adverse events)
Time Frame: 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).
|
from infusion of fibrinogen concentrate to day 45
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Hongjia Zhang, M.D., Beijing Anzhen Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Z141100002114025
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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