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Completed

NCT Number: NCT02605330

Kinetics of Plasma Fibrinogen in Cardiac Surgery

The study intends to measure fibrinogen plasma levels during the first 24 hrs in cardiac and thoracic surgical patients who undergo surgical procedures using extracorporeal circulation.

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Key information

Conditions

Fibrinogens, Abnormal Antisocial Personality Disorder Mental Disorders Personality Disorders

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Bern

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective patients undergoing coronary artery bypass grafting, aortic valve replacement or thoracic aortic surgery
  • Signed written informed consent

Exclusion criteria

  • Participation in another study
  • Language barrier to understand study purposes (e.g. french as a native language)
  • Preoperative low level of plasma fibrinogen (< 1.75 g/l)
  • Preoperative anemia (Hb < 10g/dl)
  • Emergency treatment
  • Intake of anticoagulants other than aspirin within 14 days preceding surgery.
  • Known coagulation disorder.
  • Jehovah's witnesses

Treatment and study plan

Fibrinogen plasma level

Procedure

At 12 different time points investigators plan to measure the plasma fibrinogen level with conventional coagulation tests (Clauss fibrinogen) and with ROTEM.

Primary outcomes

  1. Plasma fibrinogen concentration

    Time frame: through study completion, an average of 1 year

    Conventional (Clauss) and thromboelastometric measurement (FIBTEM)

Secondary outcomes

  1. Periprocedural thromboembolic complications

    Time frame: through study completion, an average of 1 year

  2. Thoracic drain loss

    Time frame: through study completion, an average of 1 year

    Measurement of the amount of blood collected by the thoracic drain (ml)

  3. In-hospital mortality

    Time frame: through study completion, an average of 1 year

  4. Intensive Care Unit (ICU) length of stay

    Time frame: through study completion, an average of 1 year

  5. Platelet count

    Time frame: through study completion, an average of 1 year

    Measurement of platelet count in the laboratory

  6. Prothrombin time (Quick)

    Time frame: through study completion, an average of 1 year

    Measurement of Quick in the laboratory

  7. Activated partial thromboplastin time (aPTT)

    Time frame: through study completion, an average of 1 year

    Measurement of aPTT in the laboratory

  8. Thromboelastometric (ROTEM) parameters (e.g., INTEM, EXTEM, HEPTEM)

    Time frame: through study completion, an average of 1 year

    Measurement of ROTEM parameter (unit mm) in the laboratory

  9. Thrombin concentration

    Time frame: through study completion, an average of 1 year

    Thrombin concentration in the plasma as measured in the laboratory

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Kinetics of Plasma Fibrinogen During Cardiac and Thoracic Aortic Surgery

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Nov 16, 2015
Registry last updated
Sep 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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