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

NCT ID: NCT02724605

Last Updated: 2018-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-08-31

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.

Conditions

Red Blood Cells Transfusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group A

Red blood cells unit age 14 days or less

Group Type: OTHER

Red blood cells unit age 14 days or less

Intervention Type: BIOLOGICAL

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

Group B

Red blood cells unit age more than 14 days

Group Type: OTHER

Red blood cells unit age more than 14 days

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: 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

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: collaborator

Abdelrady S Ibrahim, MD

OTHER

Sponsor Role: lead

Responsible Party

Abdelrady S Ibrahim, MD

Assistant professor of Anesthesia and Intensive care

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Abdelrady S Ibrahim

Role: PRINCIPAL_INVESTIGATOR

Assistant professor of anesthesia and intensive care

Locations

Assiut university faculty of medicine

Asyut, , Egypt

Countries

Egypt

References

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

Reference Type: BACKGROUND

PMID: 25504276 (View on PubMed)

Other Identifiers

IRB0000871236

Identifier Type: -

Identifier Source: org_study_id