- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04282382
Intraoperative Transfusion Practice in Children
August 23, 2021 updated by: Dr. Florian Piekarski, Johann Wolfgang Goethe University Hospital
A Retrospective Analysis of Perioperative Transfusion Management in Children
The purpose of this study is to examine factors, impact and outcome on perioperative blood transfusion for pediatric patients.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
66
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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NRW
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Frankfurt, NRW, Germany, 60598
- Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second to 17 years (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All pediatric patients being operated an receiving transfusion will be included.
Description
Inclusion Criteria:
- Operation
- Anaesthesia
- Transfusion (pRBC, plasma or platelets)
Exclusion Criteria:
- No
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of children being transfused intraoperative
Time Frame: 01.04.2018 to 31.10.2019
|
Amount of transfused pRBC, plasma, thrombocytes will be evaluated in children undergoing surgery
|
01.04.2018 to 31.10.2019
|
|
Documented transfusion indication
Time Frame: 01.04.2018 to 31.10.2019
|
Physiologic transfusion triggers will be evaluated (Hb Level, lactate, venous O2 saturation, levels of catecholamines)
|
01.04.2018 to 31.10.2019
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2020
Primary Completion (Actual)
October 1, 2020
Study Completion (Actual)
October 15, 2020
Study Registration Dates
First Submitted
February 17, 2020
First Submitted That Met QC Criteria
February 21, 2020
First Posted (Actual)
February 24, 2020
Study Record Updates
Last Update Posted (Actual)
August 24, 2021
Last Update Submitted That Met QC Criteria
August 23, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- KGU_FP_2020_CA5
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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