Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-05 @ 5:15 PM
Study NCT ID:
NCT02711332
Status:
COMPLETED
Last Update Posted:
2016-03-17
First Post:
2015-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating the Influence of Haemolysis on the Potassium Concentration After Capillary Blood Sampling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006461', 'term': 'Hemolysis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-11', 'studyFirstSubmitDate': '2015-11-24', 'studyFirstSubmitQcDate': '2016-03-11', 'lastUpdatePostDateStruct': {'date': '2016-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measured potassium concentration in capillary blood tests compared to venous blood tests.', 'timeFrame': '1 hour'}], 'secondaryOutcomes': [{'measure': 'Correlation from fHb and potassium', 'timeFrame': '1 hour'}, {'measure': 'Degree of haemolysis in capillary blood tests compared to venous blood tests.', 'timeFrame': '1 hour'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hemolysis']}, 'descriptionModule': {'briefSummary': 'This is an open, single-centre trial investigating the impact of haemolysis after capillary blood collection to the measured potassium concentration in Plasma healthy subjects. Each subject will have four capillary blood collections on different fingers. Two on the right and two on the left hand. Additionally as a reference a venous blood collection will be conducted.', 'detailedDescription': 'K@Home\\_1 a working package of the FFG project "K@Home - potassium home monitoring for patients with heart- and kidney insufficiency". In the project K@Home a potassium measuring system serveable by the patients even of the home monitoring should be developed.\n\nAim from K@Home is to allow an everyday home monitoring of the potassium value by the development of potassium-test stripe, like with the diabetes patients who supervise their blood sugar level by measurements with glucose-test stripe from a drop of capillary blood from the finger berry and with it the emergencies and hospital admissions to reduce or to prevent. It is fact that haemolysis has a strong influence on the measured potassium concentration. It is likely that by using capillary blood a haemolysis appears and therefore distorted potassium concentrations are measured.\n\nIn the study K@Home\\_1 it is a matter of evaluating, how high the degree of the haemolysis in capillary blood is, and in this fact to what extent leads to wrong potassium values. The results from this study will be a basic component for the sensor development.\n\nAfter clarification the approval the Informed Consent is signed and the inclusion as well as exclusion criteria (incl. demography, concomitant medication and medical history) or vital parameters (blood pressure, pulse, size, weight), are raised. An urine-pregnancy test is also carried out for the exclusion of a pregnancy in women capable of bearing children. It is not necessary that the subjects seem sober on the study day.\n\nWith 22 healthy subjects capillary and venous blood is taken within the scope of one single study round. Blood is taken from the test persons by trained specialist staff of two fingertips of each hand (a total of four fingertips). The capillary blood sampling occurs in 200 ยต l Lithium-Heparin Sarsted Microvettes and in each case the first drop of blood is rejected. To guarantee a light blood decrease without strong mechanical pressure, the hands are warmed up before the capillary sampling required with the help of an electric blanket or by warm water roughly on room temperature.\n\nIn addition 15 ml blood from the vein of a forearm is taken.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Communtiy Sample', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female\n* Healthy\n* Signed informed consent before any trial-related activities\n\nExclusion Criteria:\n\n* Severe acute and/or chronic diseases\n* Mental incapacity, unwillingness of language barriers precluding adequate understanding or cooperation\n* Pregnancy or breastfeeding\n* Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject'}, 'identificationModule': {'nctId': 'NCT02711332', 'briefTitle': 'Investigating the Influence of Haemolysis on the Potassium Concentration After Capillary Blood Sampling', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Investigating the Influence of Haemolysis on the Potassium Concentration After Capillary Blood Sampling', 'orgStudyIdInfo': {'id': 'K@Home_1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Degree of Haemolysis', 'description': 'Each subject will have four capillary blood sampling on different fingers. A reference venous blood sampling will be conducted.', 'interventionNames': ['Other: capillary blood sampling', 'Other: venous blood sampling']}], 'interventions': [{'name': 'capillary blood sampling', 'type': 'OTHER', 'otherNames': ['capillary blood sampling on fingertips'], 'description': 'Each subject will have four capillary blood collections on different fingers. A reference venous blood collection will be conducted.', 'armGroupLabels': ['Degree of Haemolysis']}, {'name': 'venous blood sampling', 'type': 'OTHER', 'otherNames': ['blood sampling'], 'description': 'Each subject will have four capillary blood collections on different fingers. A reference venous blood collection will be conducted.', 'armGroupLabels': ['Degree of Haemolysis']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Julia Mader, Prof.Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Graz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Joanneum Research Forschungsgesellschaft mbH', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}