Cardiovascular DiseasesNCT03096665

Effectiveness of Point of Care Blood Analysis Obtained From Skin Puncture Blood

An observational study of Cardiovascular Diseases and Acute Abdomen, run by Hanyang University at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This study aimed to evaluate the correlation between the point of care blood analysis obtained from skin puncture blood and conventional blood analysis obtained from venous and arterial blood. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Cardiovascular Diseases, Acute Abdomen, Respiratory Disease
What is being tested?: blood test
How many people: 250 participants
Where: 1 siteSouth Korea
Study dates: 1 Apr 2017to 30 Sep 2017
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 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The patients who require the blood test (venous blood test, skin puncture blood test and arteria blood gas analysis) of the patients presenting to the emergency department during the study period

Who may be able to join

The patients who simultaneously require the venous blood test, skin puncture blood test and arterial blood gas analysis

Who cannot join

Unstable patients
Patients receiving the medications affecting the results of blood analysis.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Hanyang university guri hospital, Department of emergency medicine
Guri-si, GyeongGido, 471-701

Other trials in South Korea

About this study

Official title: Correlation Between the Point of Care Blood Analysis Obtained From Skin Puncture Blood and Conventional Blood Analysis Obtained From Venous and Arterial Blood

This study aimed to evaluate the correlation between the point of care blood analysis obtained from skin puncture blood and conventional blood analysis obtained from venous and arterial blood.

Conditions: Cardiovascular Diseases, Acute Abdomen, Respiratory Disease, Renal Disease, Cerebrovascular Disorders
Being tested: blood test
Keywords: venous blood, arterial blood, capillary blood
Medical subject headings: Cardiovascular Diseases, Abdomen, Acute, Respiration Disorders, Kidney Diseases, Cerebrovascular Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

blood testDiagnostic test
Point of care blood analysis obtained from skin puncture

Study groups in NCT03096665
Study group	Role	What they receive
Blood test group		All patients receive the three types of blood test (venous blood test, skin puncture blood (capillary blood) test and arterial blood gas analysis Receives: Diagnostic Test: blood test

What is being measured

The primary outcome is the main question the study is designed to answer.

Blood analysis between capillary blood, venous blood and arterial blood
Primary outcome
1. Correlation of blood concentration between skin puncture blood and venous blood
- variables Na+ (mmol/L) K+ (mmol/L) Ca++ (mmol/L) Hct (%) Glucose (mg/dl) Creatinine (mg/dl) Cl- (mmol/L)
1. Correlation of blood concentration between skin puncture blood and arterial blood
- variables pH pCO2 (mmHg) pO2 (mmHg) HCO3 (mmol/L) Lactate (mmol/L)
Spearman correlation rank test will be performed to show the agreement of two methods in each value.
We will show the correlation coefficient for all values. Ex) The correlation coefficient of Na+, K+, Ca2+, Hct, glucose, creatinine and Cl- are ___, ___, ___, ___, ___, ___, ___, respectively.
Measured: within 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201730 Sep 2017

First posted30 Mar 2017
Study start1 Apr 2017
Primary completion30 Sep 2017 (estimated)
Study completion30 Sep 2017 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Cardiovascular DiseasesStudies 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: Case only
Time perspective: Prospective
Enrolment: 250 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03096665
Sponsor's protocol ID: SKINFUNCTURE2017
Status last verified: Apr 2017
First submitted: 14 Mar 2017
Last updated: 18 Apr 2017
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Kupke IR, Kather B, Zeugner S. On the composition of capillary and venous blood serum. Clin Chim Acta. 1981 May 5;112(2):177-85. doi: 10.1016/0009-8981(81)90376-4.
PubMed 7237825
Sobiech P, Pomianowski A, Stopyra A, Kuleta Z, Zbanyszek M, Procajlo A, Rajski K. Acid-base balance parameters and ionic composition of arterial, venous and capillary blood in goats. Pol J Vet Sci. 2004;7(2):117-21.
PubMed 15230543
Blumenfeld TA, Hertelendy WG, Ford SH. Simultaneously obtained skin-puncture serum, skin-puncture plasma, and venous serum compared, and effects of warming the skin before puncture. Clin Chem. 1977 Sep;23(9):1705-10.
PubMed 890915
Falch DK. Clinical chemical analyses of serum obtained from capillary versus venous blood, using Microtainers and Vacutainers. Scand J Clin Lab Invest. 1981 Feb;41(1):59-62. doi: 10.3109/00365518109092015.
PubMed 7256193

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Correlation Between the Point of Care Blood Analysis Obtained From Skin Puncture Blood and Conventional Blood Analysis Obtained From Venous and Arterial Blood
ClinicalTrials.gov ID: NCT03096665
Acronym / sponsor ID: SKINFUNCTURE2017
Conditions: Cardiovascular Diseases, Acute Abdomen, Respiratory Disease, Renal Disease, Cerebrovascular Disorders
Keywords: venous blood, arterial blood, capillary blood
Study type: Observational
Recruitment status: Unknown status
Enrolment: 250 participants (estimated)
Lead sponsor: Hanyang UniversityUniversity, hospital or other
Study start: 1 Apr 2017 (actual)
Primary completion: 30 Sep 2017 (estimated)
Study completion: 30 Sep 2017 (estimated)
First posted: 30 Mar 2017 (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.

This study aimed to evaluate the correlation between the point of care blood analysis obtained from skin puncture blood and conventional blood analysis obtained from venous and arterial blood.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Blood test group	–	Diagnostic Test: blood testAll patients receive the three types of blood test (venous blood test, skin puncture blood (capillary blood) test and arterial blood gas analysis

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The patients who require the blood test (venous blood test, skin puncture blood test and arteria blood gas analysis) of the patients presenting to the emergency department during the study period

Key inclusion criteria (1 listed)

The patients who simultaneously require the venous blood test, skin puncture blood test and arterial blood gas analysis

Key exclusion criteria (2 listed)

Unstable patients
Patients receiving the medications affecting the results of blood analysis.

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 testPoint of care blood analysis obtained from skin puncture	Diagnostic test	Blood test group

Primary outcome

Blood analysis between capillary blood, venous blood and arterial blood
Time frame: within 1 hour
Primary outcome 1. Correlation of blood concentration between skin puncture blood and venous blood * variables Na+ (mmol/L) K+ (mmol/L) Ca++ (mmol/L) Hct (%) Glucose (mg/dl) Creatinine (mg/dl) Cl- (mmol/L) 2. Correlation of blood concentration between skin puncture blood and arterial blood * variables pH pCO2 (mmHg) pO2 (mmHg) HCO3 (mmol/L) Lactate (mmol/L) Spearman correlation rank test will be performed to show the agreement of two methods in each value. We will show the correlation coefficient for all values. Ex) The correlation coefficient of Na+, K+, Ca2+, Hct, glucose, creatinine and Cl- are ___, ___, ___, ___, ___, ___, ___, respectively.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
Results publication: PubMed 7237825Kupke IR, Kather B, Zeugner S. On the composition of capillary and venous blood serum. Clin Chim Acta. 1981 May 5;112(2):177-85. doi: 10.1016/0009-8981(81)90376-4.
Results publication: PubMed 15230543Sobiech P, Pomianowski A, Stopyra A, Kuleta Z, Zbanyszek M, Procajlo A, Rajski K. Acid-base balance parameters and ionic composition of arterial, venous and capillary blood in goats. Pol J Vet Sci. 2004;7(2):117-21.
Results publication: PubMed 890915Blumenfeld TA, Hertelendy WG, Ford SH. Simultaneously obtained skin-puncture serum, skin-puncture plasma, and venous serum compared, and effects of warming the skin before puncture. Clin Chem. 1977 Sep;23(9):1705-10.
Results publication: PubMed 7256193Falch DK. Clinical chemical analyses of serum obtained from capillary versus venous blood, using Microtainers and Vacutainers. Scand J Clin Lab Invest. 1981 Feb;41(1):59-62. doi: 10.3109/00365518109092015.
Individual participant dataSharing planned: Undecided

Related trials for Cardiovascular Diseases

Active, not recruitingPhase 3
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Ischemic Optic Neuropathy
Active, not recruiting
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Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
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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.

The record lists no contact. Use the official record to reach the sponsor.

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 Cardiovascular Diseases and Acute Abdomen, run by Hanyang University at 1 site in South Korea.

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 1 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: status not confirmed, as of the sponsor's last update on 18 Apr 2017. 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 South Korea. 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?

Results are not available in the source record.

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?

Blood analysis between capillary blood, venous blood and arterial blood (time frame: within 1 hour). 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 NCT03096665, which also lists 4 linked publications.

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 Apr 2017.