Congenital Heart Disease in ChildrenTransPédiaNCT05128084
Amotosalen and Platelet Transfusion in Pediatric Heart Surgery
An observational study of Congenital Heart Disease in Children, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
High level of security during blood transfusion has been achieved by donor selection and pathogen detection using serology or direct identification. Nevertheless, blood banking becomes hazardous during epidemic outbreaks or facing new pathogens. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Congenital Heart Disease in Children
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2020to 31 Dec 2021
- 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 1 year to 17 years
- All sexes
- Child
Study population: Minor patient having had cardiac surgery act under cardiopulmonary bypass for correction of congenital heart disease
Who may be able to join
- Minor patient (<18 years old)
- Cardiac surgery act under cardiopulmonary bypass for correction of congenital heart disease
- Platelet transfusion for any reason
- Cardiac surgery performed at Bordeaux or Strasbourg University Hospital over two periods:
- Period A: January 01, 2016 - June 30, 2017 (before treatment)
- Period B: January 01, 2018 - June 30, 2019 (after treatment)
- Subject (and / or his parental authority) not having expressed, after information, his opposition to the reuse of his data for the purposes of this research
Who cannot join
- Subject (and / or his parental authority) having expressed, after information, his opposition to the reuse of his data for the purposes of this research
- Presence or installation of transient circulatory assistance (outside of the CEC) or definitive
- Heart or cardiopulmonary transplantation
Trial locations and contacts
1 site in 1 country.
Saïd CHAYER, PhD, HDR contact
France1 site, 1 recruiting
- Recruiting
Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Xavier DELABRANCHE, MD, 33 3 69 55 09 36, xavier.delabranche@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, said.chayer@chru-strasbourg.fr
About this study
Official title: Platelet Transfusion in Pediatric Heart Surgery and Impact of Amotosalen Treatment
High level of security during blood transfusion has been achieved by donor selection and pathogen detection using serology or direct identification. Nevertheless, blood banking becomes hazardous during epidemic outbreaks or facing new pathogens. Amotosalen, a psoralen, targets nucleic acids and destroys them after ultraviolet exposure, resulting in inactivation of pathogens.
Treatment inoccuity and efficacy have been demonstrated but preservation of platelet functions after treatment is still debated. Previous studies focused on hematological patients. There is no evidence for an increased requirement of transfused platelets to achieve platelet count target. Studies in heart surgery are lacking.
The investigators perform a multicenter, retrospective, "before/after", controlled study in minor patients requiring heart surgery with cardiopulmonary bypass. One center (Strasbourg) uses Amotosalen-treated platelet concentrates since 2006 (control arm). This treatment becomes available in Bordeaux in October 2017 (intervention arm). There is two periods of inclusion: one "before" (January 2016 to June 2017) and one "after" (January 2018 to June 2019).
- Conditions
- Congenital Heart Disease in Children
- Keywords
- Congenital Heart, Platelet transfusion, Procoagulant drugs, Amotosalen, Pediatric heart surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective study of the non-inferiority of treatment with Amotosalen of platelet concentrates over transfusion during pediatric cardiac surgery
Measured: Files analysed retrospectively from January 01, 2016 to June 30, 2019 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start1 Oct 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease in ChildrenStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier DELABRANCHE, MD, Principal investigator, Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128084
- Sponsor's protocol ID
- 7977
- Acronym
- TransPédia
- Status last verified
- Oct 2021
- First submitted
- 12 Oct 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Transfusion in Pediatric Heart Surgery and Impact of Amotosalen Treatment
- ClinicalTrials.gov ID
- NCT05128084
- Acronym / sponsor ID
- TransPédia / 7977
- Conditions
- Congenital Heart Disease in Children
- Keywords
- Congenital Heart, Platelet transfusion, Procoagulant drugs, Amotosalen, Pediatric heart surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 19 Nov 2021 (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.
High level of security during blood transfusion has been achieved by donor selection and pathogen detection using serology or direct identification. Nevertheless, blood banking becomes hazardous during epidemic outbreaks or facing new pathogens. Amotosalen, a psoralen, targets nucleic acids and destroys them after ultraviolet exposure, resulting in inactivation of pathogens.
Treatment inoccuity and efficacy have been demonstrated but preservation of platelet functions after treatment is still debated. Previous studies focused on hematological patients. There is no evidence for an increased requirement of transfused platelets to achieve platelet count target. Studies in heart surgery are lacking.
The investigators perform a multicenter, retrospective, "before/after", controlled study in minor patients requiring heart surgery with cardiopulmonary bypass. One center (Strasbourg) uses Amotosalen-treated platelet concentrates since 2006 (control arm). This treatment becomes available in Bordeaux in October 2017 (intervention arm). There is two periods of inclusion: one "before" (January 2016 to June 2017) and one "after" (January 2018 to June 2019).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Minor patient having had cardiac surgery act under cardiopulmonary bypass for correction of congenital heart disease
Key inclusion criteria (7 listed)
- Minor patient (<18 years old)
- Cardiac surgery act under cardiopulmonary bypass for correction of congenital heart disease
- Platelet transfusion for any reason
- Cardiac surgery performed at Bordeaux or Strasbourg University Hospital over two periods:
- Subject (and / or his parental authority) not having expressed, after information, his opposition to the reuse of his data for the purposes of this research
Key exclusion criteria (3 listed)
- Subject (and / or his parental authority) having expressed, after information, his opposition to the reuse of his data for the purposes of this research
- Presence or installation of transient circulatory assistance (outside of the CEC) or definitive
- Heart or cardiopulmonary transplantation
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
Retrospective study of the non-inferiority of treatment with Amotosalen of platelet concentrates over transfusion during pediatric cardiac surgery
Time frame: Files analysed retrospectively from January 01, 2016 to June 30, 2019 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 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.
Saïd CHAYER, PhD, HDR contact
Xavier DELABRANCHE, MD principal investigator
Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg
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 Congenital Heart Disease in Children, run by University Hospital, Strasbourg, France at 1 site in France.
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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Nov 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xavier DELABRANCHE, MD (33 3 69 55 09 36, xavier.delabranche@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective study of the non-inferiority of treatment with Amotosalen of platelet concentrates over transfusion during pediatric cardiac surgery (time frame: Files analysed retrospectively from January 01, 2016 to June 30, 2019 will be examined]). 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 19 Nov 2021.