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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04146493
Other study ID # 4-2957/2017
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date November 30, 2021

Study information

Verified date November 2023
Source Karolinska University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Heparin-Binding protein is a protein from primary and secretory granluae of white blood cells. It is released when white blood cells become activated and has been advocated as a biomarker for sepsis. The aim of this study is to find out if Heparins in clinical doses can change the level of Heparin-binding protein in plasma.


Description:

Blood samples are taken from patients before and after Heparins in clinical doses. The effects of heparins on Heparin-binding protein concentration in plasma is measured. This is a small observational study.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date November 30, 2021
Est. primary completion date November 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Planned endovascular treatment of aortic aneurysm or peripheral vascular surgery where unfractionated heparin in >3000 units are given perioperatively - Planned subcutaneous low molecular weight heparin as a thromboprophylactic treatment after major surgery or on Intensive Care treated patients. - Planned open heart surgery with cardiopulmonary bypass. Exclusion Criteria: - Under 18 years - Unable to get informed consent from patient or relative

Study Design


Intervention

Diagnostic Test:
Blood samples for Heparin-binding protein measurement
Blood samples before and after given heparin

Locations

Country Name City State
Sweden Halla Halldorsdottir Stockholm Solna

Sponsors (2)

Lead Sponsor Collaborator
Halla Halldorsdottir Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in the level of Heparin-binding protein Blood samples are taken before and after given heparin Repeated blood sampling during minimum of 1 hour and maximum of 5 hours after given heparin
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