Clinical trial NCT02542306: Safety and Efficacy of Fibrinogen Concentrate in Aortic Arch Surgery Involving Moderate Hypothermic Circulatory Arrest
Official title: Safety and Efficacy of Fibrinogen Concentrate in Aortic Arch Surgery Involving Moderate Hypothermic Circulatory Arrest
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Proximal Aortic Dissection
Keywords: Blood loss
coagulopathy
fibrinogen concentrate
transfusion
Lead sponsor: Beijing Municipal Science & Technology Commission
Sponsor class: OTHER
Collaborators: name: Beijing Anzhen Hospital
First posted: 2015-09-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: efficacy endpoint (the volumes of allogeneic blood products, volumes of cumulative drainage within 24 h and 48 h and 5 days
timeFrame: from the time of fibrinogen concentrate administration until the 5th postoperative day
Secondary outcomes:
measure: safety endpoint (incidence of serious adverse events)
timeFrame: from infusion of fibrinogen concentrate to day 45
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: Hongjia Zhang, M.D.
role: STUDY_CHAIR
References: