The Effect of Red Blood Cells Storage Duration on Biochem... | NCT02724605

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

NCT02724605

Sponsor

Abdelrady S Ibrahim, MD

Status

Completed

Last Update Posted

Jan 8, 2018Actual

Enrollment

100Actual

Phase

Phase 2

Conditions

Red Blood Cells Transfusion

Interventions

Red blood cells unit age 14 days or less
Red blood cells unit age more than 14 days

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016Actual

Primary Completion Date

Jun 2017Actual

Completion Date

Aug 2017Actual

First Submitted Date

Mar 20, 2016

First Submission Date that Met QC Criteria

Mar 30, 2016

First Posted Date

Mar 31, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2018

Last Update Posted Date

Jan 8, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Abdelrady S Ibrahim, MD, Assistant professor of Anesthesia and Intensive care, Assiut UniversitySponsor-Investigator

Lead Sponsor

Abdelrady S Ibrahim, MDOTHER

Collaborators

Name	Class
Assiut University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Other	Red blood cells unit age 14 days or less	Biological: Red blood cells unit age 14 days or less
Group B	Other	Red blood cells unit age more than 14 days	Biological: Red blood cells unit age more than 14 days

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum potassium level	Mmol/l	One hour after red blood cells transfusion

Secondary Outcomes

Measure	Description	Time Frame
Serum ionised calcium	mg/dl	One hour after red blood cells transfusion
Serum glucose level	Mmol/l	One hour after red blood cells transfusion

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Abdelrady S Ibrahim	Assistant professor of anesthesia and intensive care	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut university faculty of medicine		Asyut			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25504276	Background	Qu L, Triulzi DJ. Clinical effects of red blood cell storage. Cancer Control. 2015 Jan;22(1):26-37. doi: 10.1177/107327481502200105.