ThrombocytopeniaNCT02263157
Evaluate the Association Between Infection and Thrombocytopenia
An observational study of Thrombocytopenia, run by Jinling Hospital, China.
Trial summary
The study is designed to evaluate the association between nosocomial bloodstream infection and the occurrence of thrombocytopenia in surgical critical ill patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Thrombocytopenia
- How many people
- 390 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jun 2014
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sequential consenting adult patients of either sex were prospectively enrolled into the study.
Who may be able to join
- Sequential consenting adult patients of either sex were prospectively enrolled into the study.
Who cannot join
- Patients who passed away within 24 hours after hospitalization would be excluded.
- Patients who developed into a bloodstream infection within 48 hours after hospital admission were also excluded.
About this study
Official title: Evaluate the Association Between Blood Stream Infection (BSI) and Thrombocytopenia (Surgical Intensive Care Unit)SICU Patients
The study is designed to evaluate the association between nosocomial bloodstream infection and the occurrence of thrombocytopenia in surgical critical ill patients.
- Conditions
- Thrombocytopenia
- Medical subject headings
- Thrombocytopenia
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 |
|---|---|---|
| BSI group with thrombocytopenia | BSI patients with thrombocytopenia | |
| Non-BSI group with thrombocytopenia | Non-BSI patients with thrombocytopenia | |
| BSI group without thrombocytopenia | BSI patients without thrombocytopenia | |
| Non-BSI group without thrombocytopenia | Non-BSI patients without thrombocytopenia |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rate
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startJan 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianan Ren, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263157
- Sponsor's protocol ID
- BSI-PLT
- Status last verified
- Oct 2014
- First submitted
- 5 Oct 2014
- Last updated
- 13 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Association Between Blood Stream Infection (BSI) and Thrombocytopenia (Surgical Intensive Care Unit)SICU Patients
- ClinicalTrials.gov ID
- NCT02263157
- Acronym / sponsor ID
- BSI-PLT
- Conditions
- Thrombocytopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 13 Oct 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.
The study is designed to evaluate the association between nosocomial bloodstream infection and the occurrence of thrombocytopenia in surgical critical ill patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BSI group with thrombocytopenia | – | –BSI patients with thrombocytopenia |
| Non-BSI group with thrombocytopenia | – | –Non-BSI patients with thrombocytopenia |
| BSI group without thrombocytopenia | – | –BSI patients without thrombocytopenia |
| Non-BSI group without thrombocytopenia | – | –Non-BSI patients without thrombocytopenia |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sequential consenting adult patients of either sex were prospectively enrolled into the study.
Key inclusion criteria (1 listed)
- Sequential consenting adult patients of either sex were prospectively enrolled into the study.
Key exclusion criteria (2 listed)
- Patients who passed away within 24 hours after hospitalization would be excluded.
- Patients who developed into a bloodstream infection within 48 hours after hospital admission were also excluded.
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
mortality rate
Time frame: 28 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 13 Oct 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytopenia, run by Jinling Hospital, China.
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 2 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 13 Oct 2014. 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?
mortality rate (time frame: 28 days). 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 13 Oct 2014.