TransfusionNCT04282382
Intraoperative Transfusion Practice in Children
An observational study of Transfusion, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The purpose of this study is to examine factors, impact and outcome on perioperative blood transfusion for pediatric patients. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Transfusion
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2020to 15 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 17 years
- All sexes
- Child
Study population: All pediatric patients being operated an receiving transfusion will be included.
Who may be able to join
- Operation
- Anaesthesia
- Transfusion (pRBC, plasma or platelets)
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University
Frankfurt, North Rhine-Westphalia, 60598
About this study
Official title: 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.
- Conditions
- Transfusion
- Keywords
- Transfusion, Pediatric, Patient Blood Management
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of children being transfused intraoperative
Amount of transfused pRBC, plasma, thrombocytes will be evaluated in children undergoing surgery
Measured: 01.04.2018 to 31.10.2019
Documented transfusion indication
Physiologic transfusion triggers will be evaluated (Hb Level, lactate, venous O2 saturation, levels of catecholamines)
Measured: 01.04.2018 to 31.10.2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start1 Mar 2020
- Primary completion1 Oct 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransfusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Florian Piekarski, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282382
- Sponsor's protocol ID
- KGU_FP_2020_CA5
- Status last verified
- Aug 2021
- First submitted
- 17 Feb 2020
- Last updated
- 24 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis of Perioperative Transfusion Management in Children
- ClinicalTrials.gov ID
- NCT04282382
- Acronym / sponsor ID
- KGU_FP_2020_CA5
- Conditions
- Transfusion
- Keywords
- Transfusion, Pediatric, Patient Blood Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine factors, impact and outcome on perioperative blood transfusion for pediatric patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- All pediatric patients being operated an receiving transfusion will be included.
Key inclusion criteria (3 listed)
- Operation
- Anaesthesia
- Transfusion (pRBC, plasma or platelets)
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transfusion, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of children being transfused intraoperative (time frame: 01.04.2018 to 31.10.2019). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.