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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04212819
Other study ID # 2015/7-165
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2014
Est. completion date December 31, 2015

Study information

Verified date December 2019
Source Afyonkarahisar University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 31, 2015
Est. primary completion date April 1, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Only patients with deep anemia and anemia due to gastrointestinal bleeding patients in need of erythrocyte suspension transfusion were included.

Exclusion Criteria:

- Patients with history of hypertension, diabetes, coronary artery disease, congestive heart failure, chronic renal failure, liver failure were not included to the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Before Erythrocyte Suspension (ES)
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.
After Erythrocyte Suspension (ES)
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Afyonkarahisar University of Health Sciences

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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