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

NCT02542306 | Unknown Phase 2 DMC

• 1 other identifier: Z141100002114025
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Proximal Aortic Dissection

Keywords

Blood loss; coagulopathy; fibrinogen concentrate; transfusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• safety endpoint (incidence of serious adverse events)

  from infusion of fibrinogen concentrate to day 45

Study Arms (2)

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.

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

Interventions

fibrinogen concentrate DRUG

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.

fibrinogen concentrate-treated group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hongjia Zhang: lead
• Beijing Anzhen Hospital: collaborator

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Hemorrhage; Hemostatic Disorders

Interventions

Fibrinogen

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Acute-Phase Proteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Blood Coagulation Factors; Protein Precursors; Biological Factors

Study Officials

• Hongjia Zhang, M.D.

  Beijing Anzhen Hospital

  STUDY CHAIR

Central Study Contacts

Hongjia Zhang, M.D.

CONTACT

hongjia722@outlook.com

Xinliang Guan, M.D.

CONTACT

guanxl119@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.Clinical research

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: September 7, 2015
• Study Start: July 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 7, 2015

Record last verified: 2015-09

Locations

CN (1)