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: Unknown
• Conditions: Proximal Aortic Dissection
• Intervention / Treatment: Drug: fibrinogen concentrate

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: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • 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: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

2

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.	Drug: fibrinogen concentrate; 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	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)	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: Hongjia Zhang
• Collaborators: Beijing Anzhen Hospital
• Investigators: Study Chair: Hongjia Zhang, M.D., Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: August 25, 2015
• First Submitted That Met QC Criteria: September 4, 2015
• First Posted (Estimate): September 7, 2015

Study Record Updates

• Last Update Posted (Estimate): September 7, 2015
• Last Update Submitted That Met QC Criteria: September 4, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: coagulopathy; transfusion; fibrinogen concentrate; Blood loss
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: Z141100002114025