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?

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

Study Overview

• Status: Completed
• Conditions: Red Blood Cells Transfusion
• Intervention / Treatment: Biological: Red blood cells unit age 14 days or less; Biological: Red blood cells unit age more than 14 days

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group A; Red blood cells unit age 14 days or less	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
Other: Group B; Red blood cells unit age more than 14 days	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Abdelrady S Ibrahim, MD
• Collaborators: Assiut University
• Investigators: Principal Investigator: Abdelrady S Ibrahim, Assistant professor of anesthesia and Intensive Care

Publications and helpful links

General Publications

• Qu L, Triulzi DJ. Clinical effects of red blood cell storage. Cancer Control. 2015 Jan;22(1):26-37. doi: 10.1177/107327481502200105.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: March 20, 2016
• First Submitted That Met QC Criteria: March 30, 2016
• First Posted (Estimate): March 31, 2016

Study Record Updates

• Last Update Posted (Actual): January 8, 2018
• Last Update Submitted That Met QC Criteria: January 4, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Pediatric; RBCS,; Transfusion,; Changes
• Other Study ID Numbers: IRB0000871236

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided