HemorrhagePBM-USZNCT02473666
Patient Blood Management - Use and Outcome
An observational study of Hemorrhage, run by University of Zurich at 1 site in Switzerland.
Trial summary
Study the influence of transfusion related Patient Blood Management Program actions on transfusion-related outcome measures and cost. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemorrhage
- How many people
- 250,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2012to Dec 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All cases of all in hospital patients. Area of Focus: Transfusions of blood products.
Who may be able to join
- Only case records, all discharged patients of the University Hospital of Zürich
Who cannot join
- Not discharged from our Hospital.
Trial locations and contacts
1 site in 1 country.
About this study
Study the influence of transfusion related Patient Blood Management Program actions on transfusion-related outcome measures and cost.
Read the detailed description
At the University Hospital of Zurich, an in-house designed monitoring and feedback system was introduced which electronically registers each transfusion of any allogeneic blood product, be it red blood cells, plasma or platelets as well as corresponding laboratory data. Results are reported quarterly to Department heads. The investigator analyzes whether the introduction of this monitoring and feedback system as part of a patient blood management Program has a significant influence on use of allogeneic blood product transfusions and transfusion-related costs, without compromising patient outcome.
- Conditions
- Hemorrhage
- Keywords
- Patient Blood Management, Red Blood Cells, Platelet
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All Health Conditions. | All Health Conditions. Area of Focus: Transfusions of blood products. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of transfusions per participant
Participant wich had transfusion will be identified and the administrative, financial and clinical data will be compared to participants without transfusions
Measured: participants will be followed form date of hospital entry until date of discharge or date of death up to 3 years
Secondary outcomes (3)
Percentage of transfusion of any blood product per participant
Count of any blood products per case, QM Data
Measured: participants will be followed form date of hospital entry until date of discharge or date of death up to 3 years
Cost of any blood product per participant
costs per case
Measured: participants will be followed form date of hospital entry until date of discharge or date of death up to 3 years
Survey of Patient Blood Management System
clinical, financial,and administrative data of all participants will be reviewed on the focus on transfusions
Measured: participants will be followed form date of hospital entry until date of discharge or date of death up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study startJan 2012
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 250,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donat R Spahn, Prof, Principal investigator, IFA University Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473666
- Sponsor's protocol ID
- KEK 2015-0175
- Acronym
- PBM-USZ
- Status last verified
- Nov 2020
- First submitted
- 11 May 2015
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Blood Management - Use and Outcome
- ClinicalTrials.gov ID
- NCT02473666
- Acronym / sponsor ID
- PBM-USZ / KEK 2015-0175
- Conditions
- Hemorrhage
- Keywords
- Patient Blood Management, Red Blood Cells, Platelet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250,000 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 16 Jun 2015 (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.
Study the influence of transfusion related Patient Blood Management Program actions on transfusion-related outcome measures and cost.
Detailed description
At the University Hospital of Zurich, an in-house designed monitoring and feedback system was introduced which electronically registers each transfusion of any allogeneic blood product, be it red blood cells, plasma or platelets as well as corresponding laboratory data. Results are reported quarterly to Department heads. The investigator analyzes whether the introduction of this monitoring and feedback system as part of a patient blood management Program has a significant influence on use of allogeneic blood product transfusions and transfusion-related costs, without compromising patient outcome.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Health Conditions. | – | –All Health Conditions. Area of Focus: Transfusions of blood products. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All cases of all in hospital patients. Area of Focus: Transfusions of blood products.
Key inclusion criteria (1 listed)
- Only case records, all discharged patients of the University Hospital of Zürich
Key exclusion criteria (1 listed)
- Not discharged from our Hospital.
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
Percentage of transfusions per participant
Time frame: participants will be followed form date of hospital entry until date of discharge or date of death up to 3 years
Participant wich had transfusion will be identified and the administrative, financial and clinical data will be compared to participants without transfusions
3 secondary outcomes
Percentage of transfusion of any blood product per participant
Time frame: participants will be followed form date of hospital entry until date of discharge or date of death up to 3 years
Cost of any blood product per participant
Time frame: participants will be followed form date of hospital entry until date of discharge or date of death up to 3 years
Survey of Patient Blood Management System
Time frame: participants will be followed form date of hospital entry until date of discharge or date of death up to 3 years
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 12 Nov 2020.
Related trials for Hemorrhage
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
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.
Donat R Spahn, Prof principal investigator
IFA University Hospital Zurich
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 Hemorrhage, run by University of Zurich at 1 site in Switzerland.
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 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 12 Nov 2020. 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 Switzerland. 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?
Percentage of transfusions per participant (time frame: participants will be followed form date of hospital entry until date of discharge or date of death up to 3 years). 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 12 Nov 2020.