Vascular Disease, PeripheralHepHepNCT04146493
Heparin-Binding Protein and Heparins
An observational study of Vascular Disease, Peripheral and Thromboprophylaxis, run by Halla Halldorsdottir at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Disease, Peripheral, Thromboprophylaxis, Cardiovascular Diseases
- What is being tested?
- Blood samples for Heparin-binding protein measurement
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2019to 30 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Under 18 years
- Unable to get informed consent from patient or relative
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Blood samples for Heparin-binding protein measurement
- Keywords
- Heparin-binding protein, Heparin, Biomarker
- Medical subject headings
- Peripheral Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples for Heparin-binding protein measurementDiagnostic test
Blood samples before and after given heparin
| Study group | Role | What they receive |
|---|---|---|
| Vascular surgery group | Patients which are given unfractionated heparin during their vascular surgery. Receives: Diagnostic Test: Blood samples for Heparin-binding protein measurement | |
| Thromboprophylaxis group | Patients which are given low molecular heparins as a thrombosprofylax after major surgery Receives: Diagnostic Test: Blood samples for Heparin-binding protein measurement | |
| Cardiothoracic surgery | Patients which are given high dose unfractionated heparin during their open heart surgey Receives: Diagnostic Test: Blood samples for Heparin-binding protein measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the level of Heparin-binding protein
Blood samples are taken before and after given heparin
Measured: Repeated blood sampling during minimum of 1 hour and maximum of 5 hours after given heparin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start1 Apr 2019
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular Disease, PeripheralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halla Halldorsdottir
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor-investigator, Halla Halldorsdottir, Karolinska University Hospital
- Investigators
- Halla Halldorsdottir, MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146493
- Sponsor's protocol ID
- 4-2957/2017
- Acronym
- HepHep
- Status last verified
- Nov 2023
- First submitted
- 23 Oct 2019
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38318270
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heparin-binding Protein and Heparins
- ClinicalTrials.gov ID
- NCT04146493
- Acronym / sponsor ID
- HepHep / 4-2957/2017
- Keywords
- Heparin-binding protein, Heparin, Biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Halla HalldorsdottirUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vascular surgery group | – | Diagnostic Test: Blood samples for Heparin-binding protein measurementPatients which are given unfractionated heparin during their vascular surgery. |
| Thromboprophylaxis group | – | Diagnostic Test: Blood samples for Heparin-binding protein measurementPatients which are given low molecular heparins as a thrombosprofylax after major surgery |
| Cardiothoracic surgery | – | Diagnostic Test: Blood samples for Heparin-binding protein measurementPatients which are given high dose unfractionated heparin during their open heart surgey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Under 18 years
- Unable to get informed consent from patient or relative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples for Heparin-binding protein measurementBlood samples before and after given heparin | Diagnostic test | Cardiothoracic surgery, Thromboprophylaxis group, Vascular surgery group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 38318270Halldorsdottir 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Halla Halldorsdottir, MD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Disease, Peripheral and Thromboprophylaxis, run by Halla Halldorsdottir at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04146493, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.