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Bloodtranfusions After Aortic Surgery (FIBTEG)

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ClinicalTrials.gov Identifier: NCT02299947
Recruitment Status : Terminated (Slow inclusion)
First Posted : November 24, 2014
Last Update Posted : May 10, 2019
Sponsor:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 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)
Actual Study Start Date : August 1, 2014
Actual Primary Completion Date : April 26, 2018
Actual Study Completion Date : April 26, 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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02299947


Locations
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Netherlands
St Antonius hospital
Nieuwegein, Utrecht, Netherlands, 3435 CM
Sponsors and Collaborators
St. Antonius Hospital
Investigators
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Principal Investigator: Peter Noordzij, PhD St. Antonius Hospital
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Responsible Party: dr. P. Noordzij, MD PhD, St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT02299947    
Other Study ID Numbers: NL45370.100.14
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm, Thoracic
Hemorrhage
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Aortic Aneurysm
Aortic Diseases