NCT04212819

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

December 25, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 30, 2019

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

1.2 years

First QC Date

December 25, 2019

Last Update Submit

December 28, 2019

Conditions

Keywords

Erythrocyte suspensionTotal antioxidant statusTotal oxidant statusAsymmetric dimethylarginine

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

EXPERIMENTAL

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)

After erythrocyte suspension transfusion group

EXPERIMENTAL

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)

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.

Before erythrocyte suspension (ES) transfusion group

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.

After erythrocyte suspension transfusion group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Erhan BOZKURT, M.D.

    Afyonkarahisar Health Sciences University

    PRINCIPAL INVESTIGATOR

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