NCT02724605

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Abdelrady S Ibrahim, MD · Academic / Other
• Sex: All
• Age: 2 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Red Blood Cells Transfusion

Interventions

Type	Name	Description
BIOLOGICAL	Red 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
BIOLOGICAL	Red 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

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-06-01
• Completion: 2017-08-01
• First posted: 2016-03-31
• Last updated: 2018-01-08

Locations

1 site across 1 country: Egypt