Red Blood Cells TransfusionPhase 2NCT02724605
The Effect of Red Blood Cells Storage Duration on Biochemical Changes in Pediatric Patients
A Phase 2 study testing Red blood cells unit age 14 days or less and Red blood cells unit age more than 14 days in people with Red Blood Cells Transfusion, run by Abdelrady S Ibrahim, MD at 1 site in Egypt.
Trial summary
The aim of the study is to detect if the storage duration of red blood cells has impact on some biochemical parameters after intra operative transfusion in pediatric trauma patient Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Red Blood Cells Transfusion
- What is being tested?
- Red blood cells unit age 14 days or less and Red blood cells unit age more than 14 days
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to Aug 2017
- Phase
- Phase 2
- 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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- .ASA I-II physical status patients.
- Genders Eligible for Study : both .
- Age: 2_10 years
- All non-crush trauma pediatric patients need intraoperative RBC transfusion.
- RBCs transfusion Volume within 10-20ml/kg.
Who cannot join
- Patients with renal failure (serum creatinine 1.5 mg/dL)
- Hepatic insufficiency.
- Furosemide diuresis.
- Succinylcholine for rapid sequence induction.
- Electrolytes disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Intraoperative Red Blood Cells Transfusion With Different Storage Duration Has Effect on Some Biochemical Parameters in Pediatric Trauma Patients Need Intraoperative Transfusion?
The aim of the study is to detect if the storage duration of red blood cells has impact on some biochemical parameters after intra operative transfusion in pediatric trauma patient
Read the detailed description
- A pretransfusion draw of a few drops of patient venous blood, send for analysis by i-STAT Portable Clinical Analyser. Samples are processed immediately and provide laboratory quality results in 2 minutes using the CHEM 8+ i-STAT cartridge for measurement of:
- Potassium (K)
- Ionized Calcium (iCa)
- Glucose (Glu)
- Urea Nitrogen (BUN)/Urea
- Hemoglobin (Hb) and Hematocrit (Hct).
- Concurrently, a few drops of blood will be taken from the unit to be transfused will be analysed by i-STAT Portable Clinical Analyser for measurement of previous biochemical parameters.
- The details of the unit, such as draw date, volume of transfusion, and date of transfusion, will be recorded. The RBC unit will be delivered to the operative room from the blood bank in an insulated box.
- The transfusion is then given as clinically indicated at a rate of 50 to 150 mL/h based on the clinician's orders, the patient's weight, and the patient's clinical situation.
- Volumes will be transfused to children according to the following top-up transfusion equation: desired Hemoglobin (Hb) (g/dl) - actual Hemoglobin (Hb) (g/dl) x weight (kg) x 3. (usually 10-20 ml/kg).
- A second patient blood sample will be drawn one hour after the transfusion and will be analyzed by i-STAT Portable Clinical Analyser.
- Patient information will be recorded for age, weight, sex, and primary diagnosis.
- Demographic and clinical variables will be collected, to include type and quantity of all blood products and fluids received and medications administered. All surgical procedures will be documented.
- Conditions
- Red Blood Cells Transfusion
- Being tested
- Red blood cells unit age 14 days or less, Red blood cells unit age more than 14 days
- Keywords
- RBCS,, Transfusion,, Pediatric, Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red blood cells unit age 14 days or lessBiological
30 Patients who will receive units of packed red blood cells stored stored for 14 days or less
Red blood cells unit age more than 14 daysBiological
30 patients who will receive units of packed red blood cells stored for more than 14 days
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Red blood cells unit age 14 days or less Receives: Biological: Red blood cells unit age 14 days or less |
| Group B | Other | Red blood cells unit age more than 14 days Receives: Biological: Red blood cells unit age more than 14 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum potassium level
Mmol/l
Measured: One hour after red blood cells transfusion
Secondary outcomes (4)
Serum ionised calcium
mg/dl
Measured: One hour after red blood cells transfusion
Serum glucose level
Mmol/l
Measured: One hour after red blood cells transfusion
Blood Urea Nitrogen
mg/dL
Measured: One hour after red blood cells transfusion
Hemoglobin level
g/dl
Measured: One hour after red blood cells transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Red Blood Cells TransfusionStudies 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abdelrady S Ibrahim, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor-investigator, Abdelrady S Ibrahim, MD, Assiut University
- Investigators
- Abdelrady S Ibrahim, Principal investigator, Assistant professor of anesthesia and intensive care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724605
- Sponsor's protocol ID
- IRB0000871236
- Status last verified
- Jan 2018
- First submitted
- 20 Mar 2016
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Qu L, Triulzi DJ. Clinical effects of red blood cell storage. Cancer Control. 2015 Jan;22(1):26-37. doi: 10.1177/107327481502200105.
PubMed 25504276
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Intraoperative Red Blood Cells Transfusion With Different Storage Duration Has Effect on Some Biochemical Parameters in Pediatric Trauma Patients Need Intraoperative Transfusion?
- ClinicalTrials.gov ID
- NCT02724605
- Acronym / sponsor ID
- IRB0000871236
- Conditions
- Red Blood Cells Transfusion
- Keywords
- RBCS,, Transfusion,, Pediatric, Changes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Abdelrady S Ibrahim, MDUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 31 Mar 2016 (estimated)
- 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.
The aim of the study is to detect if the storage duration of red blood cells has impact on some biochemical parameters after intra operative transfusion in pediatric trauma patient
Detailed description
- A pretransfusion draw of a few drops of patient venous blood, send for analysis by i-STAT Portable Clinical Analyser. Samples are processed immediately and provide laboratory quality results in 2 minutes using the CHEM 8+ i-STAT cartridge for measurement of:
- Potassium (K)
- Ionized Calcium (iCa)
- Glucose (Glu)
- Urea Nitrogen (BUN)/Urea
- Hemoglobin (Hb) and Hematocrit (Hct).
- Concurrently, a few drops of blood will be taken from the unit to be transfused will be analysed by i-STAT Portable Clinical Analyser for measurement of previous biochemical parameters.
- The details of the unit, such as draw date, volume of transfusion, and date of transfusion, will be recorded. The RBC unit will be delivered to the operative room from the blood bank in an insulated box.
- The transfusion is then given as clinically indicated at a rate of 50 to 150 mL/h based on the clinician's orders, the patient's weight, and the patient's clinical situation.
- Volumes will be transfused to children according to the following top-up transfusion equation: desired Hemoglobin (Hb) (g/dl) - actual Hemoglobin (Hb) (g/dl) x weight (kg) x 3. (usually 10-20 ml/kg).
- A second patient blood sample will be drawn one hour after the transfusion and will be analyzed by i-STAT Portable Clinical Analyser.
- Patient information will be recorded for age, weight, sex, and primary diagnosis.
- Demographic and clinical variables will be collected, to include type and quantity of all blood products and fluids received and medications administered. All surgical procedures will be documented.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Biological: Red blood cells unit age 14 days or lessRed blood cells unit age 14 days or less |
| Group B | Other | Biological: Red blood cells unit age more than 14 daysRed blood cells unit age more than 14 days |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- .ASA I-II physical status patients.
- Genders Eligible for Study : both .
- Age: 2_10 years
- All non-crush trauma pediatric patients need intraoperative RBC transfusion.
- RBCs transfusion Volume within 10-20ml/kg.
Key exclusion criteria (5 listed)
- Patients with renal failure (serum creatinine 1.5 mg/dL)
- Hepatic insufficiency.
- Furosemide diuresis.
- Succinylcholine for rapid sequence induction.
- Electrolytes disorders.
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 |
|---|---|---|
| Red blood cells unit age 14 days or less30 Patients who will receive units of packed red blood cells stored stored for 14 days or less | Biological | Group A |
| Red blood cells unit age more than 14 days30 patients who will receive units of packed red blood cells stored for more than 14 days | Biological | Group B |
Primary outcome
Serum potassium level
Time frame: One hour after red blood cells transfusion
Mmol/l
4 secondary outcomes
Serum ionised calcium
Time frame: One hour after red blood cells transfusion
Serum glucose level
Time frame: One hour after red blood cells transfusion
Blood Urea Nitrogen
Time frame: One hour after red blood cells transfusion
Hemoglobin level
Time frame: One hour after red blood cells transfusion
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 8 Jan 2018.
- Background: PubMed 25504276Qu L, Triulzi DJ. Clinical effects of red blood cell storage. Cancer Control. 2015 Jan;22(1):26-37. doi: 10.1177/107327481502200105.
- Individual participant dataSharing planned: Undecided
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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.
Abdelrady S Ibrahim principal investigator
Assistant professor of anesthesia and intensive care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Red blood cells unit age 14 days or less and Red blood cells unit age more than 14 days in people with Red Blood Cells Transfusion, run by Abdelrady S Ibrahim, MD 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 5 inclusion and 5 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 8 Jan 2018. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Serum potassium level (time frame: One hour after red blood cells transfusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02724605, which also lists 1 linked publication.
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 8 Jan 2018.