Heparin-Binding Protein and Heparins

NCT04146493 | Completed

• 1 other identifier: 4-2957/2017
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vascular Disease, Peripheral; Thromboprophylaxis; Cardiovascular Diseases

Keywords

Heparin-binding protein; Heparin; Biomarker

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Vascular surgery group

Patients which are given unfractionated heparin during their vascular surgery.

Diagnostic Test: Blood samples for Heparin-binding protein measurement

Thromboprophylaxis group

Patients which are given low molecular heparins as a thrombosprofylax after major surgery

Diagnostic Test: Blood samples for Heparin-binding protein measurement

Cardiothoracic surgery

Patients which are given high dose unfractionated heparin during their open heart surgey

Diagnostic Test: Blood samples for Heparin-binding protein measurement

Interventions

Blood samples for Heparin-binding protein measurement DIAGNOSTIC_TEST

Blood samples before and after given heparin

Cardiothoracic surgery; Thromboprophylaxis group; Vascular surgery group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Under 18 years
• Unable to get informed consent from patient or relative

Sponsors & Collaborators

• Halla Halldorsdottir: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Halla Halldorsdottir

Stockholm, Solna, 17176, Sweden

Location

Related Publications (1)

• Halldorsdottir H, Lindbom L, Ebberyd A, Oldner A, Weitzberg E. The effect of heparins on plasma concentration of heparin-binding protein: a pilot study. BJA Open. 2024 Jan 27;9:100256. doi: 10.1016/j.bjao.2023.100256. eCollection 2024 Mar.

  PMID: 38318270 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma which could theoretically contain DNA

MeSH Terms

Conditions

Peripheral Vascular Diseases; Cardiovascular Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Halla Halldorsdottir, MD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 31, 2019
• Study Start: April 1, 2019
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

SE (1)