Heparin-Binding Protein and Heparins (HepHep)

November 15, 2023 updated by: Halla Halldorsdottir

Heparin-binding Protein and Heparins

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Solna
      • Stockholm, Solna, Sweden, 17176
        • Halla Halldorsdottir

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A) Patients operated for peripheral vascular disease or aortic disease B) Patients operated for major surgery C) Patients operated for open heart surgery with cardiopulmonary bypass.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vascular surgery group
Patients which are given unfractionated heparin during their vascular surgery.
Diagnostic test: Blood samples for Heparin-binding protein measurement
Blood samples before and after given heparin
Thromboprophylaxis group
Patients which are given low molecular heparins as a thrombosprofylax after major surgery
Diagnostic test: Blood samples for Heparin-binding protein measurement
Blood samples before and after given heparin
Cardiothoracic surgery
Patients which are given high dose unfractionated heparin during their open heart surgey
Diagnostic test: Blood samples for Heparin-binding protein measurement
Blood samples before and after given heparin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the level of Heparin-binding protein
Time Frame: Repeated blood sampling during minimum of 1 hour and maximum of 5 hours after given heparin
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Halla Halldorsdottir

Collaborators

Karolinska Institutet

Investigators

  • Principal Investigator: Halla Halldorsdottir, MD, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

October 23, 2019

First Submitted That Met QC Criteria

October 29, 2019

First Posted (Actual)

October 31, 2019

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2957/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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