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

Abdelrady S Ibrahim, MD

Status and phase: Completed; Phase 2

Conditions: Red Blood Cells Transfusion

Treatments: Biological: Red blood cells unit age more than 14 days; Biological: Red blood cells unit age 14 days or less

Study type: Interventional

Funder types: Other

Identifiers

NCT02724605

IRB0000871236

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 2 to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Group A

Other group

Description:

Red blood cells unit age 14 days or less

Treatment:

Biological: Red blood cells unit age 14 days or less

Group B

Other group

Description:

Red blood cells unit age more than 14 days

Treatment:

Biological: Red blood cells unit age more than 14 days