Kinetics of Plasma Fibrinogen in Cardiac Surgery

NCT ID: NCT02605330

Last Updated: 2017-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-09-14

Brief Summary

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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.

Detailed Description

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Conditions

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Fibrinogens, Abnormal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fibrinogen plasma level in CABG

In all patients undergoing coronary artery bypass grafting (CABG) the investigators plan to measure the fibrinogen plasma level

Fibrinogen plasma level

Intervention Type PROCEDURE

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

Fibrinogen plasma level in AVR

In all patients undergoing aortic valve replacement (AVR) the investigators plan to measure the fibrinogen plasma level

Fibrinogen plasma level

Intervention Type PROCEDURE

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

Fibrinogen plasma level in AAR

In all patients undergoing aortic arch replacement (AAR) the investigators plan to measure the fibrinogen plasma level

Fibrinogen plasma level

Intervention Type PROCEDURE

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

Interventions

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Fibrinogen plasma level

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gabor Erdoes, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bern

Locations

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University Hospital Bern

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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193/15

Identifier Type: -

Identifier Source: org_study_id