BleedingNCT02350101
Massive Transfusion Protocol With Coagulation Algorithm
An observational study of Bleeding, run by University of Zurich.
Trial summary
In 2008 at the University Hospital Zurich (USZ) a massive transfusion protocol was introduced. Based on laboratory diagnostics and point of care (POC) devices including ROTEM. Goal of this retrospective study is to evaluate the influence of this algorithm on coagulation, use of blood products, coagulation factors and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding
- What is being tested?
- Rotational thromboelastometry
- Type of treatment
- Medical device
- How many people
- 243 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2012
- 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: All patients needing massive transfusion (more than 10 RBCs)
Who may be able to join
- Massive transfusion
Who cannot join
- non
About this study
Official title: Introduction of a Massive Transfusion Protocol - Evaluation Over Three Years
In 2008 at the University Hospital Zurich (USZ) a massive transfusion protocol was introduced. Based on laboratory diagnostics and point of care (POC) devices including ROTEM.
Goal of this retrospective study is to evaluate the influence of this algorithm on coagulation, use of blood products, coagulation factors and ROTEM evolution.
Read the detailed description
In 2008 at the USZ a massive transfusion protocol was introduced. Based on laboratory diagnostics and POC (point of care) devices including ROTEM.
Goal of this retrospective study is to evaluate the influence of this algorithm on coagulation, use of blood products, coagulation factors and ROTEM evolution over three years (2008-2010)
- Conditions
- Bleeding
- Being tested
- Rotational thromboelastometry
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotational thromboelastometryDevice
In bleeding patients point of care measurements are performed, in this case Rotational Thromboelastometry (ROTEM) to guide the use of blood products and coagulation factors.
What is being measured
The primary outcome is the main question the study is designed to answer.
Coagulation in ROTEM
Point of care devices are used in bleeding patients. In the university hospital of Zurich an algorithm in the case of massive bleeding was introduced in 2008. The primary outcome measure is to investigate the changes of ROTEM parameters in the sense of amelioration reflected by better coagulation by using goal directed transfusions.
Measured: 3 years
Secondary outcomes (1)
Transfusion needs
To evaluate the blood products and coagulation factors needed and to evaluate if there is a reduction between the time before the introduction of the algorithm compared to afterwards.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startJan 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies 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
- Retrospective
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oliver Theusinger, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350101
- Sponsor's protocol ID
- KEK-ZH-Nr. 2010-0234/4
- Status last verified
- Jan 2015
- First submitted
- 16 Jan 2015
- Last updated
- 29 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introduction of a Massive Transfusion Protocol - Evaluation Over Three Years
- ClinicalTrials.gov ID
- NCT02350101
- Acronym / sponsor ID
- KEK-ZH-Nr. 2010-0234/4
- Conditions
- Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 Jan 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.
In 2008 at the University Hospital Zurich (USZ) a massive transfusion protocol was introduced. Based on laboratory diagnostics and point of care (POC) devices including ROTEM.
Goal of this retrospective study is to evaluate the influence of this algorithm on coagulation, use of blood products, coagulation factors and ROTEM evolution.
Detailed description
In 2008 at the USZ a massive transfusion protocol was introduced. Based on laboratory diagnostics and POC (point of care) devices including ROTEM.
Goal of this retrospective study is to evaluate the influence of this algorithm on coagulation, use of blood products, coagulation factors and ROTEM evolution over three years (2008-2010)
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients needing massive transfusion (more than 10 RBCs)
Key inclusion criteria (1 listed)
- Massive transfusion
Key exclusion criteria (1 listed)
- non
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rotational thromboelastometryIn bleeding patients point of care measurements are performed, in this case Rotational Thromboelastometry (ROTEM) to guide the use of blood products and coagulation factors. | Device | – |
Primary outcome
Coagulation in ROTEM
Time frame: 3 years
Point of care devices are used in bleeding patients. In the university hospital of Zurich an algorithm in the case of massive bleeding was introduced in 2008. The primary outcome measure is to investigate the changes of ROTEM parameters in the sense of amelioration reflected by better coagulation by using goal directed transfusions.
1 secondary outcome
Transfusion needs
Time frame: 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 29 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bleeding, run by University of Zurich.
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 29 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Coagulation in ROTEM (time frame: 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 29 Jan 2015.