Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-01-29 @ 11:26 AM
Study NCT ID:
NCT02944851
Status:
COMPLETED
Last Update Posted:
2018-05-16
First Post:
2016-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Accuracy of Non-invasive Hemoglobin Measurement (SpHb) and Vena Cava Inferior Ultrasound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-10', 'studyFirstSubmitDate': '2016-09-26', 'studyFirstSubmitQcDate': '2016-10-25', 'lastUpdatePostDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of stage 1 hemorrhagic shock', 'timeFrame': '30 minute (15 minute blood donation, 15 minute rest time ).', 'description': 'Changes in IVC diameter were observed with 500 ml blood loss. Measurement were made pre and post blood donation.'}, {'measure': 'Diagnosis of stage 1 hemorrhagic shock', 'timeFrame': '30 minute (15 minute blood donation, 15 minute rest time ).', 'description': 'Changes in SpHb were observed with 500 ml blood loss. Measurement were made pre and post blood donation.'}], 'secondaryOutcomes': [{'measure': 'Diagnosis of stage 1 hemorrhagic shock', 'timeFrame': '30 minute (15 minute blood donation, 15 minute rest time ).', 'description': 'Changes in Pulse rate were observed with 500 ml blood loss. Measurement were made pre and post blood donation.'}, {'measure': 'Diagnosis of stage 1 hemorrhagic shock', 'timeFrame': '30 minute (15 minute blood donation, 15 minute rest time ).', 'description': 'Changes in Arterial blood pressure were observed with 500 ml blood loss. Measurement were made pre and post blood donation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Blood donors', 'blood donation', 'traumatic blood loss', 'Trauma'], 'conditions': ['Blood Donors, Traumatic Blood Loss']}, 'descriptionModule': {'briefSummary': 'The aim of this work is determine the more successful noninvasive method by comparison of two noninvasive methods ( IVC ultrasound - noninvasive hemoglobin measurement (SpHb)) that used in the detection of patients with blood loss.\n\nThe works were completed in 6 months. The study was conducted at the blood donation center and in Emergency department. Vital parameters were measured and recorded before making the voluntary blood donation. Following Masimo brand portable device fingers SpHb value was measured.Then IVC diameter of patients in the supine position were measured using ultrasonography. Then he left to donors return in routine blood donation programme. A unit (500ml) of blood were drawn from each donor. After the blood donation process measured and recorded the vital signs again. SpHb was measured noninvasively from finger again. Following these measurements were recorded again by measuring the diameter of IVC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Voluntary donors for blood donation.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Who have volunteered to donate blood\n* Older than 18 years\n* Both sexes\n\nExclusion Criteria:\n\n* Known tricuspid valve regurgitation and right heart failure\n* Oral intake or the fluid loss (diarrhea and vomiting-urination) between the two measurements during the blood donation\n* Inappropriate echogenicity for vena cava inferior diameter measurement'}, 'identificationModule': {'nctId': 'NCT02944851', 'briefTitle': 'Comparison of the Accuracy of Non-invasive Hemoglobin Measurement (SpHb) and Vena Cava Inferior Ultrasound', 'organization': {'class': 'OTHER', 'fullName': 'Haseki Training and Research Hospital'}, 'officialTitle': 'Comparison of Noninvasive Two Methods to Monitoring Blood Loss; Inferior Vena Cava (IVC) Ultrasound - Non-invasive Hemoglobin Measurement (SpHb)', 'orgStudyIdInfo': {'id': '336'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prospective observational', 'description': 'The changes of IVC diameter, SpHb and vital signs of blood donors were observed after blood donation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34096', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Haseki Training and Reseurch Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Adnan Yamanoğlu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The health ministry, Haseki Training and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haseki Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Emergency medicine specialist, Emergency Department', 'investigatorFullName': 'Adnan Yamanoğlu', 'investigatorAffiliation': 'Haseki Training and Research Hospital'}}}}