Pulmonary HypertensionPhase 4NCT02050230
Hemodynamic Effects of Stored Blood Transfusion in Intensive Care Patients
A Phase 4 study testing Blood transfusion in people with Pulmonary Hypertension, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Transfusion of stored blood has been associated with increased pulmonary vascular resistance in lambs. The investigators hypothesize that transfusion of one unit of red blood cells stored under standard conditions in intensive care patients will increase pulmonary arterial pressure and pulmonary vascular resistance to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Blood transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2014to Jun 2016
- Phase
- Phase 4
- 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
Who may be able to join
- The patient has a pulmonary artery catheter in place
- Transfusion of 1 unit of packed red blood cells indicated for standard intensive care therapy
- The patient has an arterial catheter
Who cannot join
- Age < 18 years
- Clinical prediction that the patient will not survive at least 48 hours
- Acute bleeding: > 2 units of packed red blood cells/hour
- Vasopressor use: noradrenalin > 0.2 μg/kg/min or any use of adrenalin within 6 hours of inclusion into the study
- Therapy with inhaled NO, inhaled prostacyclin, or phosphodiesterase-5-inhibitors
- Sepsis
Trial locations and contacts
1 site in 1 country.
Austria1 site
General Hospital of the Medical University of Vienna
Vienna, 1090
About this study
Transfusion of stored blood has been associated with increased pulmonary vascular resistance in lambs. The investigators hypothesize that transfusion of one unit of red blood cells stored under standard conditions in intensive care patients will increase pulmonary arterial pressure and pulmonary vascular resistance to a greater extent than will one unit of fresh red blood cells.
- Conditions
- Pulmonary Hypertension
- Being tested
- Blood transfusion
- Keywords
- transfusion, pulmonary hypertension, intensive care medicine
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood transfusionBiological
One unit of red blood cells will be transfused over the course of 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Fresh blood transfusion | Active comparator | One unit of blood stored for less than 14 days Receives: Biological: Blood transfusion |
| Standard issue blood transfusion | Experimental | One unit of blood stored under standard conditions Receives: Biological: Blood transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary arterial pressure
Measured: Change from baseline to immediately after transfusion (time frame of 20 min)
Pulmonary vascular resistance
Measured: Change from baseline to immediately after transfusion (time frame of 20 min)
Secondary outcomes (2)
Systemic pressure
Measured: Change from baseline to immediately after transfusion (time frame of 20 min)
Systemic vascular resistance
Measured: Change from baseline to immediately after transfusion (time frame of 20 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Protracted recruitment of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David M Baron, MD, Medical University of Vienna
- Investigators
- Roman Ullrich, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050230
- Sponsor's protocol ID
- BASG 2013-002316-27
- Other IDs
- 2013-002316-27
- Status last verified
- Oct 2016
- First submitted
- 17 Jan 2014
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of Stored Blood Transfusion in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT02050230
- Acronym / sponsor ID
- BASG 2013-002316-27
- Conditions
- Pulmonary Hypertension
- Keywords
- transfusion, pulmonary hypertension, intensive care medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protracted recruitment of patients
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Jan 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.
Transfusion of stored blood has been associated with increased pulmonary vascular resistance in lambs. The investigators hypothesize that transfusion of one unit of red blood cells stored under standard conditions in intensive care patients will increase pulmonary arterial pressure and pulmonary vascular resistance to a greater extent than will one unit of fresh red blood cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fresh blood transfusion | Active comparator | Biological: Blood transfusionOne unit of blood stored for less than 14 days |
| Standard issue blood transfusion | Experimental | Biological: Blood transfusionOne unit of blood stored under standard conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient has a pulmonary artery catheter in place
- Transfusion of 1 unit of packed red blood cells indicated for standard intensive care therapy
- The patient has an arterial catheter
Key exclusion criteria (6 listed)
- Age < 18 years
- Clinical prediction that the patient will not survive at least 48 hours
- Acute bleeding: > 2 units of packed red blood cells/hour
- Vasopressor use: noradrenalin > 0.2 μg/kg/min or any use of adrenalin within 6 hours of inclusion into the study
- Therapy with inhaled NO, inhaled prostacyclin, or phosphodiesterase-5-inhibitors
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 |
|---|---|---|
| Blood transfusionOne unit of red blood cells will be transfused over the course of 20 minutes | Biological | Fresh blood transfusion, Standard issue blood transfusion |
Primary outcome
Pulmonary arterial pressure
Time frame: Change from baseline to immediately after transfusion (time frame of 20 min)
Pulmonary vascular resistance
Time frame: Change from baseline to immediately after transfusion (time frame of 20 min)
2 secondary outcomes
Systemic pressure
Time frame: Change from baseline to immediately after transfusion (time frame of 20 min)
Systemic vascular resistance
Time frame: Change from baseline to immediately after transfusion (time frame of 20 min)
Results and safety
The study was stopped early (reason given: Protracted recruitment of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
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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.
Roman Ullrich, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood transfusion in people with Pulmonary Hypertension, run by Medical University of Vienna at 1 site in Austria.
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 6 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: stopped early, as of the sponsor's last update on 27 Oct 2016. 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 Austria. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Protracted recruitment of patients). Results are not available in the source record.
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?
Pulmonary arterial pressure (time frame: Change from baseline to immediately after transfusion (time frame of 20 min)). 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 27 Oct 2016.