Excessive Amount of Blood / Fluid TransfusionNCT02149069
Blood Management Program in the Post - Operative Period.
An observational study of Excessive Amount of Blood / Fluid Transfusion, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial summary
A care path in the field of transfusion medicine was creates at ASMN - IRCCS addressed to patients undergoing complex surgical procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Excessive Amount of Blood / Fluid Transfusion
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2014to Jan 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing complex surgical procedures
Who may be able to join
- -All patients undergoing complex surgical procedures
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS-Arcispedale Santa Maria Nuova
Reggio Emilia, Emilia-Romagna, 42123
Pamela Berni, Biology, +39-0522-295057, pamela.berni@asmn.re.it
Di Bartolomeo Erminia, Physician
About this study
Official title: Blood Management Program: Appropriateness of Transfusion Therapy in the Post - Operative Period.
A care path in the field of transfusion medicine was creates at ASMN - IRCCS addressed to patients undergoing complex surgical procedures.
Read the detailed description
This pathway is called Blood Management Program (BMP).
The implementation of this process should improve transfusion therapy in the peri-operative period in order to:
- correct the transfusional approach to surgical patients
- optimize the management of transfusional resources (red blood cells, plasma, platelets)
- optimize the management of plasma derivatives, drugs and techniques designed to limit the use of homologous blood
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of therapeutic appropriateness for Red Cells - Plasma - Platelets transfusion: comparison between prospective vs. retrospective data in ASMN ,Reggio Emilia (Italy)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive Amount of Blood / Fluid 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
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Principal investigator, PAMELABERNI, Azienda USL Reggio Emilia - IRCCS
- Investigators
- Erminia Di Bartolomeo, MD, Principal investigator, ASMN-IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149069
- Sponsor's protocol ID
- BMP - TRASFU1
- Status last verified
- Jun 2015
- First submitted
- 26 May 2014
- Last updated
- 3 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Management Program: Appropriateness of Transfusion Therapy in the Post - Operative Period.
- ClinicalTrials.gov ID
- NCT02149069
- Acronym / sponsor ID
- BMP - TRASFU1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 29 May 2014 (estimated)
- 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.
A care path in the field of transfusion medicine was creates at ASMN - IRCCS addressed to patients undergoing complex surgical procedures.
Detailed description
This pathway is called Blood Management Program (BMP).
The implementation of this process should improve transfusion therapy in the peri-operative period in order to:
- correct the transfusional approach to surgical patients
- optimize the management of transfusional resources (red blood cells, plasma, platelets)
- optimize the management of plasma derivatives, drugs and techniques designed to limit the use of homologous blood
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing complex surgical procedures
Key inclusion criteria (1 listed)
- -All patients undergoing complex surgical procedures
Key exclusion criteria (0 listed)
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
Evaluation of therapeutic appropriateness for Red Cells - Plasma - Platelets transfusion: comparison between prospective vs. retrospective data in ASMN ,Reggio Emilia (Italy)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2015.
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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.
Erminia Di Bartolomeo, MD principal investigator
ASMN-IRCCS
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 Excessive Amount of Blood / Fluid Transfusion, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
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 1 inclusion and 0 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 3 Aug 2015. 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 Italy. 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 Berni Pamela, Doctor (0039-0522-295601, pamela.berni@asmn.re.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of therapeutic appropriateness for Red Cells - Plasma - Platelets transfusion: comparison between prospective vs. retrospective data in ASMN ,Reggio Emilia (Italy) (time frame: 24 months). 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 3 Aug 2015.