AnemiaNCT04212819
Before and After Erythrocyte Suspension Transfusion
A study testing Before Erythrocyte Suspension (ES) and After Erythrocyte Suspension (ES) in people with Anemia and Oxidative Stress, run by Afyonkarahisar Health Sciences University.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anemia, Oxidative Stress
- What is being tested?
- Before Erythrocyte Suspension (ES) and After Erythrocyte Suspension (ES)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 31 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Only patients with deep anemia and anemia due to gastrointestinal bleeding patients in need of erythrocyte suspension transfusion were included.
Who cannot join
- Patients with history of hypertension, diabetes, coronary artery disease, congestive heart failure, chronic renal failure, liver failure were not included to the study
About this study
Official title: 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.
- Conditions
- Anemia, Oxidative Stress
- Being tested
- Before Erythrocyte Suspension (ES), After Erythrocyte Suspension (ES)
- Keywords
- Erythrocyte suspension, Total antioxidant status, Total oxidant status, Asymmetric dimethylarginine
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Before Erythrocyte Suspension (ES)Other
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)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: After Erythrocyte Suspension (ES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start1 Jan 2014
- Primary completion1 Apr 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erhan BOZKURT, Afyonkarahisar Health Sciences University
- Investigators
- Erhan BOZKURT, M.D., Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212819
- Sponsor's protocol ID
- 2015/7-165
- Status last verified
- Dec 2019
- First submitted
- 25 Dec 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oxidative Stress and Asymmetric Dimethyl Arginine Levels Before and After Erythrocyte Suspension Transfusion
- ClinicalTrials.gov ID
- NCT04212819
- Acronym / sponsor ID
- 2015/7-165
- Conditions
- Anemia, Oxidative Stress
- Keywords
- Erythrocyte suspension, Total antioxidant status, Total oxidant status, Asymmetric dimethylarginine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Apr 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 30 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before erythrocyte suspension (ES) transfusion group | Experimental | Other: Before Erythrocyte Suspension (ES)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. |
| After erythrocyte suspension transfusion group | Experimental | Other: After Erythrocyte Suspension (ES)24 hours after ES transfusion, total antioxidant status (TAS), total oxidant status (TOS) and ADMA levels were measured from the patients. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Only patients with deep anemia and anemia due to gastrointestinal bleeding patients in need of erythrocyte suspension transfusion were included.
Key exclusion criteria (1 listed)
- Patients with history of hypertension, diabetes, coronary artery disease, congestive heart failure, chronic renal failure, liver failure were not included to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Before erythrocyte suspension (ES) transfusion group |
| 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. | Other | After erythrocyte suspension transfusion group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
Related trials for Anemia
Active, not recruitingObservational study
Long Term Follow-up Observational Study After Clinical Trials of AMG531 (Romiplostim) in Patients With Untreated Aplastic Anemia
Aplastic Anemia
RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
Sickle Cell Disorders, Sickle Cell Disease
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
A Long-term Follow-up Study of Patients With ARD103 CAR-T Cell Therapies
Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia, in Relapsed or Refractory
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erhan BOZKURT, M.D. principal investigator
Afyonkarahisar Health Sciences University
Questions about this trial
What is this clinical trial studying?
A study testing Before Erythrocyte Suspension (ES) and After Erythrocyte Suspension (ES) in people with Anemia and Oxidative Stress, run by Afyonkarahisar Health Sciences University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole Blood Count Test (time frame: 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020; AzTrials last refreshed its copy on 31 Oct 2026.