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

Phase 2

Completed

• Conditions: Red Blood Cells Transfusion
• Interventions: Biological: Red blood cells unit age 14 days or less; Biological: Red blood cells unit age more than 14 days

• Registration Number: NCT02724605
• Lead Sponsor: Abdelrady S Ibrahim, MD

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-03-20
• Study First Submitted QC: 2016-03-30
• Study First Posted: 2016-03-31
• Primary Completion: 2017-06
• Study Completion: 2017-08
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-04
• Last Update Posted: 2018-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Red blood cells unit age 14 days or less	Red blood cells unit age 14 days or less
Group B	Red blood cells unit age more than 14 days	Red blood cells unit age more than 14 days

Primary Outcome Measures

Name	Time	Method
Serum potassium level	One hour after red blood cells transfusion	Mmol/l

Secondary Outcome Measures

Name	Time	Method
Serum ionised calcium	One hour after red blood cells transfusion	mg/dl
Serum glucose level	One hour after red blood cells transfusion	Mmol/l
Blood Urea Nitrogen	One hour after red blood cells transfusion	mg/dL
Hemoglobin level	One hour after red blood cells transfusion	g/dl

Trial Locations

Locations (1)

Assiut university faculty of medicine; 🇪🇬 Assiut, Egypt