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Clinical Trials/NCT02724605
NCT02724605CompletedPhase 2

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

Abdelrady S Ibrahim, MD1 site in 1 country100 target enrollmentStarted: January 1, 2016Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Serum potassium level
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
2 Years to 10 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Group A

Other

Red blood cells unit age 14 days or less

Intervention: Red blood cells unit age 14 days or less (Biological)

Group B

Other

Red blood cells unit age more than 14 days

Intervention: Red blood cells unit age more than 14 days (Biological)

Outcomes

Primary Outcomes

Serum potassium level

Time Frame: One hour after red blood cells transfusion

Mmol/l

Secondary Outcomes

  • Hemoglobin level(One hour after red blood cells transfusion)
  • Blood Urea Nitrogen(One hour after red blood cells transfusion)
  • Serum glucose level(One hour after red blood cells transfusion)
  • Serum ionised calcium(One hour after red blood cells transfusion)

Investigators

Sponsor
Abdelrady S Ibrahim, MD
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Abdelrady S Ibrahim, MD

Assistant professor of Anesthesia and Intensive care

Assiut University

Study Sites (1)

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