ThrombocytopeniaNCT02306044
Bleeding Prediction in Thrombocytopenia
An observational study of Thrombocytopenia, run by Pernille Just Vinholt.
Trial summary
The purpose of the study is to investigate whether platelet indices from automated haematology equipment, whole blood impedance aggregometry and a standardized bleeding questionnaire predict bleeding in admitted patients with thrombocytopenia of various causes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thrombocytopenia
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Dec 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: Admitted patients with thrombocytopenia of any cause
Who may be able to join
- Admitted patients with thrombocytopenia
- Age ≥18 years
- Platelet count below 80 x109/L
Who cannot join
- Platelet transfusion within the previous 14 days,
- surgery or trauma within the previous 7 days
- Unable to give informed consent.
About this study
Official title: Bleeding Prediction in Thrombocytopenia Using Platelet Indices, Platelet Aggregometry and a Standardized Bleeding Questionnaire
The purpose of the study is to investigate whether platelet indices from automated haematology equipment, whole blood impedance aggregometry and a standardized bleeding questionnaire predict bleeding in admitted patients with thrombocytopenia of various causes.
Read the detailed description
Thrombocytopenia is a risk factor for bleeding, but studies concerning markers for stratification of bleeding risk among thrombocytopenic patients are lacking. This prospective observational cohort study investigates risk factor for bleeding in admitted patients with thrombocytopenia of various causes.
- Conditions
- Thrombocytopenia
- Keywords
- Bleeding, Platelet indices, Platelet aggregometry, Bleeding questionnaire
- Medical subject headings
- Thrombocytopenia, Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean platelet volume
Mean platelet volume (femtolitre (fL))
Measured: 30 days
Secondary outcomes (4)
Platelet count
Platelet count ( x10'9/L)
Measured: 30 days
immature platelet fraction
immature platelet fraction (%)
Measured: 30 days
Bleeding questionnaire
Bleeding score based on the condensed MCMDM-1 VWD bleeding questionnaire
Measured: 30 days
Platelet aggregation
Platelet aggregation by Multiplate Analyzer (aggregation units* min)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startApr 2013
- Primary completionDec 2013
- Study completionDec 2013
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pernille Just Vinholt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pernille Just Vinholt, Odense University Hospital
- Investigators
- Pernille J Vinholt, MD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306044
- Sponsor's protocol ID
- s-20120088
- Status last verified
- Aug 2019
- First submitted
- 24 Nov 2014
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bleeding Prediction in Thrombocytopenia Using Platelet Indices, Platelet Aggregometry and a Standardized Bleeding Questionnaire
- ClinicalTrials.gov ID
- NCT02306044
- Acronym / sponsor ID
- s-20120088
- Conditions
- Thrombocytopenia
- Keywords
- Bleeding, Platelet indices, Platelet aggregometry, Bleeding questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Pernille Just VinholtUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Dec 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 purpose of the study is to investigate whether platelet indices from automated haematology equipment, whole blood impedance aggregometry and a standardized bleeding questionnaire predict bleeding in admitted patients with thrombocytopenia of various causes.
Detailed description
Thrombocytopenia is a risk factor for bleeding, but studies concerning markers for stratification of bleeding risk among thrombocytopenic patients are lacking. This prospective observational cohort study investigates risk factor for bleeding in admitted patients with thrombocytopenia of various causes.
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
- Admitted patients with thrombocytopenia of any cause
Key inclusion criteria (3 listed)
- Admitted patients with thrombocytopenia
- Age ≥18 years
- Platelet count below 80 x109/L
Key exclusion criteria (3 listed)
- Platelet transfusion within the previous 14 days,
- surgery or trauma within the previous 7 days
- Unable to give informed consent.
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
Mean platelet volume
Time frame: 30 days
Mean platelet volume (femtolitre (fL))
4 secondary outcomes
Platelet count
Time frame: 30 days
immature platelet fraction
Time frame: 30 days
Bleeding questionnaire
Time frame: 30 days
Platelet aggregation
Time frame: 30 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 28 Aug 2019.
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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.
Pernille J Vinholt, MD principal investigator
Odense University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytopenia, run by Pernille Just Vinholt.
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 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 28 Aug 2019. 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?
Mean platelet volume (time frame: 30 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 28 Aug 2019.