Safety and Efficacy of Fibrinogen Concentrate in Aortic Arch Surgery Involving Moderate Hypothermic Circulatory Arrest (SEFC)

Hongjia Zhang

Status and phase: Unknown; Phase 2

Conditions: Proximal Aortic Dissection

Treatments: Drug: fibrinogen concentrate

Study type: Interventional

Funder types: Other

Identifiers

NCT02542306

Z141100002114025

Details and patient eligibility

About

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.

Full 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).

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

fibrinogen concentrate-treated group

Experimental group

Description:

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.

Treatment:

Drug: fibrinogen concentrate

non-fibrinogen concentrate-treated group

No Intervention group

Description:

The participants who did not received fibrinogen concentrate treatment were enrolled as the non-fibrinogen concentrate-treated group