NCT02724605

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

January 8, 2018

Status Verified

January 1, 2018

Enrollment Period

1.4 years

First QC Date

March 20, 2016

Last Update Submit

January 4, 2018

Conditions

Red Blood Cells Transfusion

Keywords

RBCS,Transfusion,PediatricChanges

Outcome Measures

Primary Outcomes (1)

  • Serum potassium level

    Mmol/l

    One hour after red blood cells transfusion

Secondary Outcomes (4)

  • Serum ionised calcium

    One hour after red blood cells transfusion

  • Serum glucose level

    One hour after red blood cells transfusion

  • Blood Urea Nitrogen

    One hour after red blood cells transfusion

  • Hemoglobin level

    One hour after red blood cells transfusion

Study Arms (2)

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

Red blood cells unit age 14 days or lessBIOLOGICAL

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

Group A
Red blood cells unit age more than 14 daysBIOLOGICAL

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

Group B

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with renal failure (serum creatinine 1.5 mg/dL)
  • Hepatic insufficiency.
  • Furosemide diuresis.
  • Succinylcholine for rapid sequence induction.
  • Electrolytes disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university faculty of medicine

Asyut, Egypt

Location

Related Publications (1)

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

    PMID: 25504276BACKGROUND

Study Officials

  • Abdelrady S Ibrahim

    Assistant professor of anesthesia and intensive care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor of Anesthesia and Intensive care

Study Record Dates

First Submitted

March 20, 2016

First Posted

March 31, 2016

Study Start

January 1, 2016

Primary Completion

June 1, 2017

Study Completion

August 1, 2017

Last Updated

January 8, 2018

Record last verified: 2018-01

Locations

EG(1)