Platelet FunctionNCT00748878
Platelet Function During ECMO (Extra Corporeal Membrane Oxygenation)
An observational study of Platelet Function and Thrombocytopenia, run by University of Utah at 1 site in United States.
Trial summary
Platelet transfusions are routinely administered during neonatal ECMO, with an average of 1.3 platelet transfusions per day being administered while a patient is undergoing ECMO treatment. The cause of thrombocytopenia during ECMO largely involves platelet adherence to the oxygenator membrane. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Platelet Function, Thrombocytopenia
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jun 2013
- 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: Any patient on ECMO will be eligible for study.
Who may be able to join
- Any patient on ECMO will be eligible for study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Primary Children's Medical Center
Salt Lake City, Utah, 84113
About this study
Official title: Platelet Function During ECMO
Platelet transfusions are routinely administered during neonatal ECMO, with an average of 1.3 platelet transfusions per day being administered while a patient is undergoing ECMO treatment. The cause of thrombocytopenia during ECMO largely involves platelet adherence to the oxygenator membrane. Platelet transfusions carry risks such as infections with bacteria or yeast, and development or worsening of pulmonary hypertension. It is likely that if fewer platelet transfusions can be administered during the ECMO run, the cumulative adverse effects of platelet transfusions would diminish and patient outcomes improve. In order to better understand platelet function during ECMO, the investigators plan to serially determine the circulating platelet mass, plasma platelet factor 4 concentration, megakaryocyte mass (estimated by plasma thrombopoietin concentration), and platelet function as quantified by PFA100. Any patient on ECMO will be eligible for this pilot study of 5 patients. By understanding changes in platelet function, we hope to design a future study that may modify the frequency or need for platelet transfusions during ECMO.
Read the detailed description
Platelet transfusions are routinely administered during neonatal ECMO, with an average of 1.3 platelet transfusions per day being administered while a patient is undergoing ECMO treatment.1 In general, a platelet transfusion is ordered for a patient on ECMO if the platelet count falls below 100,000/uL in order to prevent generalized hemorrhaging.1,2 The cause of thrombocytopenia during ECMO largely involves platelet adherence to the oxygenator membrane,3 but other mechanisms are also likely to be involved.4 Platelet transfusions carry risks as well as benefits.5 Infections with bacteria or yeast are the most commonly reported complications of platelet transfusions,6,7 but with multiple platelet transfusions the development or worsening of pulmonary hypertension may be another common adverse effect.8,9 Pulmonary hypertension can be the result of administering biologically active pro-inflammatory proteins (known to be present in platelet transfusions) into the venous circulation. Of note, the first capillary bed encountered will be within the pulmonary circulation.
It is likely that if fewer platelet transfusions could safely be administered during the ECMO run, the cumulative adverse effects of platelet transfusions would diminish and thereby patient outcomes might improve.
- Conditions
- Platelet Function, Thrombocytopenia
- Keywords
- To better understand platelet function during ECMO
- Medical subject headings
- Thrombocytopenia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet FunctionStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Investigators
- Donald .Null, M.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748878
- Sponsor's protocol ID
- 28645
- Status last verified
- Oct 2013
- First submitted
- 8 Sep 2008
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Function During ECMO
- ClinicalTrials.gov ID
- NCT00748878
- Acronym / sponsor ID
- 28645
- Conditions
- Platelet Function, Thrombocytopenia
- Keywords
- To better understand platelet function during ECMO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 9 Sep 2008 (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.
Platelet transfusions are routinely administered during neonatal ECMO, with an average of 1.3 platelet transfusions per day being administered while a patient is undergoing ECMO treatment. The cause of thrombocytopenia during ECMO largely involves platelet adherence to the oxygenator membrane. Platelet transfusions carry risks such as infections with bacteria or yeast, and development or worsening of pulmonary hypertension. It is likely that if fewer platelet transfusions can be administered during the ECMO run, the cumulative adverse effects of platelet transfusions would diminish and patient outcomes improve. In order to better understand platelet function during ECMO, the investigators plan to serially determine the circulating platelet mass, plasma platelet factor 4 concentration, megakaryocyte mass (estimated by plasma thrombopoietin concentration), and platelet function as quantified by PFA100. Any patient on ECMO will be eligible for this pilot study of 5 patients. By understanding changes in platelet function, we hope to design a future study that may modify the frequency or need for platelet transfusions during ECMO.
Detailed description
Platelet transfusions are routinely administered during neonatal ECMO, with an average of 1.3 platelet transfusions per day being administered while a patient is undergoing ECMO treatment.1 In general, a platelet transfusion is ordered for a patient on ECMO if the platelet count falls below 100,000/uL in order to prevent generalized hemorrhaging.1,2 The cause of thrombocytopenia during ECMO largely involves platelet adherence to the oxygenator membrane,3 but other mechanisms are also likely to be involved.4 Platelet transfusions carry risks as well as benefits.5 Infections with bacteria or yeast are the most commonly reported complications of platelet transfusions,6,7 but with multiple platelet transfusions the development or worsening of pulmonary hypertension may be another common adverse effect.8,9 Pulmonary hypertension can be the result of administering biologically active pro-inflammatory proteins (known to be present in platelet transfusions) into the venous circulation. Of note, the first capillary bed encountered will be within the pulmonary circulation.
It is likely that if fewer platelet transfusions could safely be administered during the ECMO run, the cumulative adverse effects of platelet transfusions would diminish and thereby patient outcomes might improve.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient on ECMO will be eligible for study.
Key inclusion criteria (1 listed)
- Any patient on ECMO will be eligible for study.
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
Not reported in the source record.
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 16 Oct 2013.
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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.
Donald .Null, M.D. principal investigator
University of Utah
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 Platelet Function and Thrombocytopenia, run by University of Utah at 1 site in United States.
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: finished, as of the sponsor's last update on 16 Oct 2013. 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 United States. 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.
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 16 Oct 2013.