Bloodtranfusions After Aortic Surgery (FIBTEG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02299947
Recruitment Status : Recruiting
First Posted : November 24, 2014
Last Update Posted : March 6, 2018
Information provided by (Responsible Party):
dr. P. Noordzij, St. Antonius Hospital

Brief Summary:
The purpose of this study is to answer the following question: Leads a primary coagulation corrected with a single dose of fibrinogen concentrate after ascending aorta-arc reconstruction to a decrease in the number of allogenic blood transfusions, compared to placebo?

Condition or disease Intervention/treatment Phase
Hemorrhage Thoracic Aneurysm Drug: Haemocomplettan P Drug: Placebo Phase 4

Detailed Description:
Cardiothoracic surgery (CTC) is associated with blood loss and an increased risk for impaired coagulation by the use of a CBP. Coagulation is a process of primary hemostasis by adhesion of trombocytes and aggregation, followed by secondary coagulation and fibrin formation. During CTC fibrinogen is the first coagulation factor which reaches critical concentration necessary for clotting. Point of Care clotting assay with thromboelastography (TEG) provides qualitative information on coagulation factors and clot strength. Specific coagulation factor correction of impaired clotting improves clot strength and may reduces the number of perioperative allogeneic blood transfusions, resulting in possible reduction of postoperative blood loss and reduction of the risk of re-operation in the short and long term. The hypothesis of this study is that a single dose fibrinogen concentrate immediately after CTC leads to a decrease in the number of allogenic blood transfusions in patients with clinically impaired clotting, verified by TEG.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of a Single Dose Fibrinogen With Placebo and the Number of Blood Transfusions After Ascending Aorta Surgery (FIBTEG Study)
Study Start Date : August 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Haemocomplettan P
Study patients that receive Haemocomplettan P
Drug: Haemocomplettan P
Placebo Comparator: NaCl 0.9%
Study patients that receive NaCl 0.9%
Drug: Placebo

Primary Outcome Measures :
  1. Number of transfused blood products [ Time Frame: 24 hours after surgery ]

Secondary Outcome Measures :
  1. Blood loss [ Time Frame: 24 hours after surgery ]
  2. Re-operation [ Time Frame: 30 day after surgery ]
  3. Mortality [ Time Frame: 30 day mortality ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Elective surgery for thoracic aneurysm

Exclusion Criteria:

  • Prior trombosis or myocardial infarction, congenital coagulation disorder, use of anti-coagulants prior to surgery, prior thoracic surgery, pregnancy, pre-operative fibrinogen concentration <1g/L

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02299947

Contact: Eline Vlot

St Antonius hospital Recruiting
Nieuwegein, Utrecht, Netherlands, 3435 CM
Principal Investigator: Peter Noordzij, MD PhD         
Sponsors and Collaborators
St. Antonius Hospital
Principal Investigator: Peter Noordzij, PhD St. Antonius Hospital

Responsible Party: dr. P. Noordzij, MD PhD, St. Antonius Hospital Identifier: NCT02299947     History of Changes
Other Study ID Numbers: NL45370.100.14
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Aortic Aneurysm, Thoracic
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Aortic Aneurysm
Aortic Diseases