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Completed

NCT Number: NCT02724605

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

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

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Key information

Conditions

Red Blood Cells Transfusion

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Assiut university faculty of medicine

Asyut, Egypt

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Red blood cells unit age 14 days or less

Biological

30 Patients who will receive units of packed red blood cells stored stored for 14 days or less

Red blood cells unit age more than 14 days

Biological

30 patients who will receive units of packed red blood cells stored for more than 14 days

Primary outcomes

  1. Serum potassium level

    Time frame: One hour after red blood cells transfusion

    Mmol/l

Secondary outcomes

  1. Serum ionised calcium

    Time frame: One hour after red blood cells transfusion

    mg/dl

  2. Serum glucose level

    Time frame: One hour after red blood cells transfusion

    Mmol/l

  3. Blood Urea Nitrogen

    Time frame: One hour after red blood cells transfusion

    mg/dL

  4. Hemoglobin level

    Time frame: One hour after red blood cells transfusion

    g/dl

Sponsors and collaborators

Lead sponsor

Abdelrady S Ibrahim, MD

Other

Collaborators

  • Assiut University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 31, 2016
Registry last updated
Jan 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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