Before and After Erythrocyte Suspension Transfusion

December 28, 2019 updated by: Erhan BOZKURT, Afyonkarahisar Health Sciences University

Comparison of Oxidative Stress and Asymmetric Dimethyl Arginine Levels Before and After Erythrocyte Suspension Transfusion

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Before erythrocyte suspension (ES) transfusion group
50 (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.
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.
Experimental: After erythrocyte suspension transfusion group
24 hours after ES transfusion, total antioxidant status (TAS), total oxidant status (TOS) and ADMA levels were measured from the patients.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whole Blood Count Test
Time Frame: 24 hour
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Afyonkarahisar Health Sciences University

Investigators

  • Principal Investigator: Erhan BOZKURT, M.D., Afyonkarahisar Health Sciences University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

December 31, 2015

Study Registration Dates

First Submitted

December 25, 2019

First Submitted That Met QC Criteria

December 25, 2019

First Posted (Actual)

December 30, 2019

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 28, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2015/7-165

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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