Blood Transfusion ComplicationEarly Phase 1NCT03767361
Study the Effect of Blood Transfusion on Oxidant-antioxidant Status in Term and Near-term Neonates
A Early Phase 1 study testing packed red blood cells transfusion in people with Blood Transfusion Complication and Oxidative Stress, run by Rania Ali El-Farrash at 1 site in Egypt.
Trial summary
Primary aim is to evaluate the effect of blood transfusion on oxidant-antioxidant status in premature neonates. Secondary aim is to assess the effect of the age of transfused red blood cells on the biological markers of oxidative stress. Read more about this study
- Who is it for?
- Ages 35 to 37 weeks
- Conditions the study is for
- Blood Transfusion Complication, Oxidative Stress
- What is being tested?
- packed red blood cells transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Jun 2018to 26 Feb 2020
- Phase
- Early Phase 1
- 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 35 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature neonates ≤36 weeks in need for blood transfusion.
Who cannot join
- Critically ill neonates.(perinatal asphaxia,on high setting mechanical ventilation,different types of shock eg ;septic shock and major congenital anomalies)
- Extremely low birth weight neonates(<1000gm birth weight )
- Recipient of blood transfusion before enrollment in the study.
- Neonates planned for exchange transfusion .
Trial locations and contacts
1 site in 1 country.
About this study
Primary aim is to evaluate the effect of blood transfusion on oxidant-antioxidant status in premature neonates. Secondary aim is to assess the effect of the age of transfused red blood cells on the biological markers of oxidative stress.
Read the detailed description
Oxidant-antioxidant status will be assessed by measuring total antioxidant capacity (TAC) and malondialdehyde (MDA), as well as antioxidant minerals, in 65 term and near-term neonates.
- Conditions
- Blood Transfusion Complication, Oxidative Stress
- Being tested
- packed red blood cells transfusion
- Medical subject headings
- Transfusion Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
packed red blood cells transfusionBiological
packed red blood cells transfusion
| Study group | Role | What they receive |
|---|---|---|
| Fresh PRBCs | Active comparator | Neonates will receive fresh packed red blood cells transfusion within 7 days of donation Receives: Biological: packed red blood cells transfusion |
| Old PRBCs | Active comparator | Neonates will receive fresh packed red blood cells transfusion older than 7 days yet within the standard range accepted universally will be transfused to this group. Receives: Biological: packed red blood cells transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
malondialdehyde
MDA
Measured: 2-3 hours posttransfusion
total antioxidant capacity
TAC
Measured: 2-3 hours posttransfusion
serum Copper
s.Cu
Measured: 2-3 hours posttransfusion
serum Zinc
s.Zn
Measured: 2-3 hours posttransfusion
serum magnesium
s.Mg
Measured: 2-3 hours posttransfusion
serum iron
s.Fe
Measured: 2-3 hours posttransfusion
serum Calcium
s.Ca
Measured: 2-3 hours posttransfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start13 Jun 2018
- Primary completion1 Nov 2019
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Transfusion ComplicationStudies 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rania Ali El-Farrash
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rania Ali El-Farrash, Ain Shams University
- Investigators
- Rania A. El-Farrash, M.D, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767361
- Sponsor's protocol ID
- MS2015
- Status last verified
- Aug 2020
- First submitted
- 7 Aug 2017
- Last updated
- 2 Sep 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 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study the Effect of Blood Transfusion on Oxidant-antioxidant Status in Term and Near-term Neonates
- ClinicalTrials.gov ID
- NCT03767361
- Acronym / sponsor ID
- MS2015
- Conditions
- Blood Transfusion Complication, Oxidative Stress
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Rania Ali El-FarrashUniversity, hospital or other
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 6 Dec 2018 (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.
Primary aim is to evaluate the effect of blood transfusion on oxidant-antioxidant status in premature neonates. Secondary aim is to assess the effect of the age of transfused red blood cells on the biological markers of oxidative stress.
Detailed description
Oxidant-antioxidant status will be assessed by measuring total antioxidant capacity (TAC) and malondialdehyde (MDA), as well as antioxidant minerals, in 65 term and near-term neonates.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fresh PRBCs | Active comparator | Biological: packed red blood cells transfusionNeonates will receive fresh packed red blood cells transfusion within 7 days of donation |
| Old PRBCs | Active comparator | Biological: packed red blood cells transfusionNeonates will receive fresh packed red blood cells transfusion older than 7 days yet within the standard range accepted universally will be transfused to this group. |
Who may qualify
- Ages
- 35 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Premature neonates ≤36 weeks in need for blood transfusion.
Key exclusion criteria (4 listed)
- Critically ill neonates.(perinatal asphaxia,on high setting mechanical ventilation,different types of shock eg ;septic shock and major congenital anomalies)
- Extremely low birth weight neonates(<1000gm birth weight )
- Recipient of blood transfusion before enrollment in the study.
- Neonates planned for exchange transfusion .
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 |
|---|---|---|
| packed red blood cells transfusionpacked red blood cells transfusion | Biological | Fresh PRBCs, Old PRBCs |
Primary outcome
malondialdehyde
Time frame: 2-3 hours posttransfusion
MDA
total antioxidant capacity
Time frame: 2-3 hours posttransfusion
TAC
serum Copper
Time frame: 2-3 hours posttransfusion
s.Cu
serum Zinc
Time frame: 2-3 hours posttransfusion
s.Zn
serum magnesium
Time frame: 2-3 hours posttransfusion
s.Mg
serum iron
Time frame: 2-3 hours posttransfusion
s.Fe
serum Calcium
Time frame: 2-3 hours posttransfusion
s.Ca
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 Sep 2020.
Related trials for Blood Transfusion Complication
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
Blood Transfusion Strategies During Major Surgery
Perioperative Red Blood Cell Transfusion
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
Active, not recruitingObservational study
Mechanisms of Anaphylaxis
Anaphylaxis, Allergy
Not yet recruitingPhase 2
Challenge Transfusion of INTERCEPT Pathogen Reduced Red Blood Cells (RBCs) in Subjects With or Without Pre-existing Antibodies to INTERCEPT RBCs
Transfusion Reaction, Hemolytic
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.
Rania A. El-Farrash, M.D study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing packed red blood cells transfusion in people with Blood Transfusion Complication and Oxidative Stress, run by Rania Ali El-Farrash at 1 site in Egypt.
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 4 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 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
malondialdehyde (time frame: 2-3 hours posttransfusion). The study lists 7 primary outcomes in all. 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 Sep 2020.