Clinical trial NCT02724605: The Effect of Red Blood Cells Storage Duration on Biochemical Changes in Pediatric Patients
Official title: Is Intraoperative Red Blood Cells Transfusion With Different Storage Duration Has Effect on Some Biochemical Parameters in Pediatric Trauma Patients Need Intraoperative Transfusion?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Red Blood Cells Transfusion
Keywords: RBCS,
Transfusion,
Pediatric
Changes
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Assiut University
First posted: 2016-03-31
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serum potassium level
timeFrame: One hour after red blood cells transfusion
Secondary outcomes:
measure: Serum ionised calcium
timeFrame: One hour after red blood cells transfusion
measure: Serum glucose level
timeFrame: One hour after red blood cells transfusion
measure: Blood Urea Nitrogen
timeFrame: One hour after red blood cells transfusion
measure: Hemoglobin level
timeFrame: One hour after red blood cells transfusion
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university faculty of medicine
Study officials:
affiliation: Assistant professor of anesthesia and intensive care
name: Abdelrady S Ibrahim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Qu L, Triulzi DJ. Clinical effects of red blood cell storage. Cancer Control. 2015 Jan;22(1):26-37. doi: 10.1177/107327481502200105.