Before and After Erythrocyte Suspension Transfusion
Comparison of Oxidative Stress and Asymmetric Dimethyl Arginine Levels Before and After Erythrocyte Suspension Transfusion
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
Hypoperfusion, hypoxia and ischemia occurs in circulation as a result of anemia. All of these situations lead to oxidative stress and endothelial dysfunction in the organism. In this study, the investigators aimed to investigate the oxidant-antioxidant balance and asymmetric dimethylarginine (ADMA) levels in patients that have symptomatic anemia in need of erythrocyte suspension (ES) transfusion. To the best of the investigators knowledge, there have been few studies in the literature on anemia and total oxidant, total antioxidant and ADMA levels. We aimed to observe changes in oxidative - antioxidant ADMA levels before and after ES transfusion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2014
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2015
CompletedFirst Submitted
Initial submission to the registry
December 25, 2019
CompletedFirst Posted
Study publicly available on registry
December 30, 2019
CompletedJanuary 2, 2020
December 1, 2019
1.2 years
December 25, 2019
December 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Whole Blood Count Test
Patients with deep anemia and anemia due to gastrointestinal bleeding patients in need of erythrocyte suspension transfusion were included. ES transfusion needs of the patients were determined according to clinical signs and symptoms.
24 hour
Study Arms (2)
Before erythrocyte suspension (ES) transfusion group
EXPERIMENTAL50 (Female/Male: 25/25) patients were included in this study. Total antioxidant status (TAS), total oxidant status (TOS) and ADMA levels were measured from the patients after diagnoses of anemia.
After erythrocyte suspension transfusion group
EXPERIMENTAL24 hours after ES transfusion, total antioxidant status (TAS), total oxidant status (TOS) and ADMA levels were measured from the patients.
Interventions
ES transfusion needs of the patients were determined according to clinical signs and symptoms. Vital signs were closely monitored and recorded before, during and after transfusion. Infusion was performed slowly for the first 15 minutes in terms of allergic reaction, and then the transfusion rate was adjusted according to the patient's clinic.
Venous blood samples were obtained from patients who needed ES transfusion before transfusion. Control venous blood samples were obtained from the patients who did not develop any complications for 24 hours after starting of the transfusion and became hemodynamically stable.
Eligibility Criteria
You may qualify if:
- Only patients with deep anemia and anemia due to gastrointestinal bleeding patients in need of erythrocyte suspension transfusion were included.
You may not qualify if:
- Patients with history of hypertension, diabetes, coronary artery disease, congestive heart failure, chronic renal failure, liver failure were not included to the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erhan BOZKURT, M.D.
Afyonkarahisar Health Sciences University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 25, 2019
First Posted
December 30, 2019
Study Start
January 1, 2014
Primary Completion
April 1, 2015
Study Completion
December 31, 2015
Last Updated
January 2, 2020
Record last verified: 2019-12