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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Red Blood Cells Transfusion

Intervention / Treatment
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* Biological: Red blood cells unit age 14 days or less
* Biological: Red blood cells unit age more than 14 days


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A<br>Red blood cells unit age 14 days or less | Biological: Red blood cells unit age 14 days or less<br>* 30 Patients who will receive units of packed red blood cells stored stored for 14 days or less<br>|
| Other: Group B<br>Red blood cells unit age more than 14 days | Biological: Red blood cells unit age more than 14 days<br>* 30 patients who will receive units of packed red blood cells stored for more than 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum potassium level | Mmol/l | One hour after red blood cells transfusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum ionised calcium | mg/dl | One hour after red blood cells transfusion | 
| Serum glucose level | Mmol/l | One hour after red blood cells transfusion | 
| Blood Urea Nitrogen | mg/dL | One hour after red blood cells transfusion | 
| Hemoglobin level | g/dl | One hour after red blood cells transfusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RBCS,, Transfusion,, Pediatric, Changes