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

Red Blood Cells Transfusion Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02724605
• Other study ID #: IRB0000871236
• Status: Completed
• Phase: Phase 2
• First received: March 20, 2016
• Last updated: January 4, 2018
• Start date: January 2016
• Est. completion date: August 2017

Study information

• Verified date: January 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Red Blood Cells Transfusion

Intervention

Biological:
• 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
• 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

Locations

Country	Name	City	State
Egypt	Assiut university faculty of medicine	Assiut

Sponsors (2)

Lead Sponsor	Collaborator
Abdelrady S Ibrahim, MD	Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Qu L, Triulzi DJ. Clinical effects of red blood cell storage. Cancer Control. 2015 Jan;22(1):26-37. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum potassium level	Mmol/l	One hour after red blood cells transfusion
Secondary	Serum ionised calcium	mg/dl	One hour after red blood cells transfusion
Secondary	Serum glucose level	Mmol/l	One hour after red blood cells transfusion
Secondary	Blood Urea Nitrogen	mg/dL	One hour after red blood cells transfusion
Secondary	Hemoglobin level	g/dl	One hour after red blood cells transfusion