|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT02605330 |
|
Date of registration:
|
11/11/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Kinetics of Plasma Fibrinogen in Cardiac Surgery
|
|
Scientific title:
|
Kinetics of Plasma Fibrinogen During Cardiac and Thoracic Aortic Surgery |
|
Date of first enrolment:
|
November 2015 |
|
Target sample size:
|
26 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02605330 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Switzerland
| | | | | | | |
|
Contacts
|
|
Name:
|
Gabor Erdoes, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Bern |
| | |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Fibrinogens, Abnormal
|
|
Intervention(s)
|
|
Procedure: Fibrinogen plasma level
|
|
Primary Outcome(s)
|
|
Plasma fibrinogen concentration
[Time Frame: through study completion, an average of 1 year]
|
|
Secondary Outcome(s)
|
|
Thoracic drain loss
[Time Frame: through study completion, an average of 1 year]
|
|
Periprocedural thromboembolic complications
[Time Frame: through study completion, an average of 1 year]
|
|
Platelet count
[Time Frame: through study completion, an average of 1 year]
|
|
Thromboelastometric (ROTEM) parameters (e.g., INTEM, EXTEM, HEPTEM)
[Time Frame: through study completion, an average of 1 year]
|
|
In-hospital mortality
[Time Frame: through study completion, an average of 1 year]
|
|
Activated partial thromboplastin time (aPTT)
[Time Frame: through study completion, an average of 1 year]
|
|
Thrombin concentration
[Time Frame: through study completion, an average of 1 year]
|
|
Prothrombin time (Quick)
[Time Frame: through study completion, an average of 1 year]
|
|
Intensive Care Unit (ICU) length of stay
[Time Frame: through study completion, an average of 1 year]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|