Blood TransfusionNCT02917811
Red Cell Distribution Width (RDW) as a Prognostic Marker in ICU
An observational study of Blood Transfusion and Biochemical Marker, run by Università degli Studi di Ferrara at 1 site in Italy.
Trial summary
The aim of this study is to verify if high values of RDW are useful prognostic marker for ICU mortality and 90-days mortality. Moreover, we will investigate the prognostic value of RDW in specific subgroup population with some clinical characteristic wich may modify RDW baseline values, i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Transfusion, Biochemical Marker
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2016to Nov 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: All patients admitted to ICU will be considered for the study
Who may be able to join
- Unselected ICU patients
Who cannot join
- Length of stay in ICU <48 hours
- Hematological disease
- Age <18 years
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to verify if high values of RDW are useful prognostic marker for ICU mortality and 90-days mortality. Moreover, we will investigate the prognostic value of RDW in specific subgroup population with some clinical characteristic wich may modify RDW baseline values, i.e. transfused patients or patients with high markers of hemolysis
- Conditions
- Blood Transfusion, Biochemical Marker
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 |
|---|---|---|
| ICU patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-days mortality
Measured: 90 days
Secondary outcomes (2)
ICU mortality
Measured: 90 days
Length of mechanical ventilation
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startJan 2016
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blood 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Savino Spadaro, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917811
- Sponsor's protocol ID
- 20042016
- Status last verified
- Mar 2017
- First submitted
- 13 Sep 2016
- Last updated
- 30 Mar 2017
- Results posted
- No
Publications
Kim CH, Park JT, Kim EJ, Han JH, Han JS, Choi JY, Han SH, Yoo TH, Kim YS, Kang SW, Oh HJ. An increase in red blood cell distribution width from baseline predicts mortality in patients with severe sepsis or septic shock. Crit Care. 2013 Dec 9;17(6):R282. doi: 10.1186/cc13145.
PubMed 24321201Lorente L, Martin MM, Abreu-Gonzalez P, Sole-Violan J, Ferreres J, Labarta L, Diaz C, Gonzalez O, Garcia D, Jimenez A, Borreguero-Leon JM. Red blood cell distribution width during the first week is associated with severity and mortality in septic patients. PLoS One. 2014 Aug 25;9(8):e105436. doi: 10.1371/journal.pone.0105436. eCollection 2014.
PubMed 25153089
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Red Cell Distribution Width (RDW) as a Prognostic Marker in ICU
- ClinicalTrials.gov ID
- NCT02917811
- Acronym / sponsor ID
- 20042016
- Conditions
- Blood Transfusion, Biochemical Marker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 28 Sep 2016 (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.
The aim of this study is to verify if high values of RDW are useful prognostic marker for ICU mortality and 90-days mortality. Moreover, we will investigate the prognostic value of RDW in specific subgroup population with some clinical characteristic wich may modify RDW baseline values, i.e. transfused patients or patients with high markers of hemolysis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to ICU will be considered for the study
Key inclusion criteria (1 listed)
- Unselected ICU patients
Key exclusion criteria (3 listed)
- Length of stay in ICU <48 hours
- Hematological disease
- Age <18 years
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
90-days mortality
Time frame: 90 days
2 secondary outcomes
ICU mortality
Time frame: 90 days
Length of mechanical ventilation
Time frame: 90 days
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 30 Mar 2017.
- Results publication: PubMed 24321201Kim CH, Park JT, Kim EJ, Han JH, Han JS, Choi JY, Han SH, Yoo TH, Kim YS, Kang SW, Oh HJ. An increase in red blood cell distribution width from baseline predicts mortality in patients with severe sepsis or septic shock. Crit Care. 2013 Dec 9;17(6):R282. doi: 10.1186/cc13145.
- Results publication: PubMed 25153089Lorente L, Martin MM, Abreu-Gonzalez P, Sole-Violan J, Ferreres J, Labarta L, Diaz C, Gonzalez O, Garcia D, Jimenez A, Borreguero-Leon JM. Red blood cell distribution width during the first week is associated with severity and mortality in septic patients. PLoS One. 2014 Aug 25;9(8):e105436. doi: 10.1371/journal.pone.0105436. eCollection 2014.
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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.
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 Blood Transfusion and Biochemical Marker, run by Università degli Studi di Ferrara 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 3 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 30 Mar 2017. 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?
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?
90-days mortality (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02917811, which also lists 2 linked publications.
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 30 Mar 2017.