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NCT04785274 Clinical Trial

The Effect of Non-invasive Hemoglobin Measurement in Hip Surgeries

Bleeding Clinical Trial

Official title:
The Effect of Non-invasive Hemoglobin Measurement on Blood Transfusion and Mortality in Hip Surgeries: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04785274
Other study ID # 2020-24/16/12/2020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date December 31, 2021

Study information
Verified date August 2022
Source Bulent Ecevit University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Bleeding is one of the most important causes of mortality and morbidity in patients. Hb levels are the most prevalently utilized monitoring parameter in hemorrhagic patients in the hemodynamic sense. Hemoglobin determination is studied at laboratories along with blood gasses or complete blood analysis. Recently, non-invasive techniques where measurement is made from the fingertips have been offered for use. One of these techniques is non-invasive hemoglobin (SpHb) measurement. SpHb is used as a trend monitor. Based on the severity of bleeding, the compensatory mechanisms of patients may be disrupted. This situation may lead to lower levels of toleration of anemia during bleeding. The relationship between blood transfusion and mortality is under debate.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - 18-60 years old - General anesthesia undergoing hip surgery - American society of anesthesiology (ASA) scores I-II-III Exclusion Criteria: - Receiving inotropic support - Uncontrolled diabetes - Arrhythmia - Hypothermia - Hyperbilirubinemia - Jaundice - Dark skin pigmentation - Without voluntary consent - Hypovolemia, - hypotension, - sepsis, - blood diseases

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• non-invasive hemoglobin (SpHb)
hemoglobin measuring device

Locations
Country Name City State
Turkey Zonguldak Bulent Ecevit University Medicine Faculty Zonguldak

Sponsors (1)
Lead Sponsor Collaborator
Bulent Ecevit University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hemodynamic Stability to compare blood transfusion decisions made with SpHb measurement values and with conventional methods in patient who would receive hip surgery. during the surgery
Secondary Mortality to compare the effects of transfusion results on mortality. until 3 months after surgery
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