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The Effect of Red Blood Cells Storage Duration on Biochemical Changes in Pediatric Patients

Is Intraoperative Red Blood Cells Transfusion With Different Storage Duration Has Effect on Some Biochemical Parameters in Pediatric Trauma Patients Need Intraoperative Transfusion?

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02724605
Enrollment
100
Registered
2016-03-31
Start date
2016-01-31
Completion date
2017-08-31
Last updated
2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Red Blood Cells Transfusion

Keywords

RBCS,, Transfusion,, Pediatric, Changes

Brief 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

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: 1. Potassium (K) 2. Ionized Calcium (iCa) 3. Glucose (Glu) 4. Urea Nitrogen (BUN)/Urea 5. 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.

Interventions

BIOLOGICALRed blood cells unit age 14 days or less

30 Patients who will receive units of packed red blood cells stored stored for 14 days or less

BIOLOGICALRed blood cells unit age more than 14 days

30 patients who will receive units of packed red blood cells stored for more than 14 days

Sponsors

Assiut University
CollaboratorOTHER
Abdelrady S Ibrahim, MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
No

Inclusion criteria

.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.

Exclusion criteria

* Patients with renal failure (serum creatinine 1.5 mg/dL) * Hepatic insufficiency. * Furosemide diuresis. * Succinylcholine for rapid sequence induction. * Electrolytes disorders.

Design outcomes

Primary

MeasureTime frameDescription
Serum potassium levelOne hour after red blood cells transfusionMmol/l

Secondary

MeasureTime frameDescription
Serum ionised calciumOne hour after red blood cells transfusionmg/dl
Serum glucose levelOne hour after red blood cells transfusionMmol/l
Blood Urea NitrogenOne hour after red blood cells transfusionmg/dL
Hemoglobin levelOne hour after red blood cells transfusiong/dl

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026