ThrombocytopeniaNeo-HATNCT02371330
The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study
An observational study of Thrombocytopenia, run by Karolinska Institutet at 2 sites in 2 countries.
Trial summary
This is a prospective longitudinal study that evaluates Platelet Function Analyzer-100 (PFA-100) CT-ADPs (closure time-ADP) and incidence of bleeding using the Neonatal Bleeding Assessment Tool - Neo-BAT in preterm neonates <32 weeks gestational age or with a birth weight <1500 grams and with different degrees of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thrombocytopenia
- How many people
- 76 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2015to Sep 2017
- 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: Patients admitted to the Neonatal Intensive Care Unit who are <32 weeks gestation or with a birth weight <1500 grams.
Who may be able to join
- <32 weeks gestation or with a birth weight <1500 grams;
- Have confirmed moderate-to-severe thrombocytopenia, defined as a platelet count <100x109/L;
- Have a parent/guardian willing to comply with the protocol and provide written informed consent.
Who cannot join
- Are not expected to survive by the Attending Neonatologist;
- Are thought to have a congenital thrombocytopenia or platelet dysfunction, based on family history or clinical presentation (e.g. associated congenital malformations, platelet morphology);
- Have a major chromosomal anomaly such as Trisomy 13, 18, or 21.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Department of Pediatrics, Levine Children's Hospital, Carolinas Healthcare System
Charlotte, North Carolina, 28203
Sweden1 site
Astrid Lindgren Children's Hospital, Karolinska University Hospital
Stockholm, 171 76
About this study
Official title: The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study - Neo-HAT Study
This is a prospective longitudinal study that evaluates Platelet Function Analyzer-100 (PFA-100) CT-ADPs (closure time-ADP) and incidence of bleeding using the Neonatal Bleeding Assessment Tool - Neo-BAT in preterm neonates <32 weeks gestational age or with a birth weight <1500 grams and with different degrees of thrombocytopenia.
The investigators hypothesized that PFA-100 CT-ADP, a global in vitro test of primary hemostasis, will be a better predictor of clinical bleeding in neonates than platelet count alone. A bleeding risk assessment marker could help physicians more accurately determine the risk/benefit ratio of platelet transfusions, guiding platelet transfusion decisions in neonates with thrombocytopenia.
- Conditions
- Thrombocytopenia
- Keywords
- Thrombocytopenia, Neonate, PFA-100, Neo-BAT, Hemorrhage
- Medical subject headings
- Thrombocytopenia, Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Neo-BAT score (Neo-BAT: Neonatal Bleeding Assessment Tool)
The NeoBAT is a simple, reliable and objective tool for the standardized assessment of bleeding in neonates, which was developed by an international team of experts based on the World Health Organization bleeding score for adults.
Measured: study period: 5 days
Secondary outcomes (1)
Number of thrombotic events
Measured: up to post-conceptional age 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund
- Responsible party
- Principal investigator, Emoke Deschmann, Karolinska Institutet
- Investigators
- Emoke Deschmann, M.D., M.M.Sc., Principal investigator, Department of Women's and Children's Health, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371330
- Sponsor's protocol ID
- TRF-1516
- Acronym
- Neo-HAT
- Status last verified
- Nov 2017
- First submitted
- 13 Feb 2015
- Last updated
- 17 Nov 2017
- Results posted
- No
Publications
Deschmann E, Sola-Visner M, Saxonhouse MA. Primary hemostasis in neonates with thrombocytopenia. J Pediatr. 2014 Jan;164(1):167-72. doi: 10.1016/j.jpeds.2013.08.037. Epub 2013 Oct 3.
PubMed 24094764
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study - Neo-HAT Study
- ClinicalTrials.gov ID
- NCT02371330
- Acronym / sponsor ID
- Neo-HAT / TRF-1516
- Conditions
- Thrombocytopenia
- Keywords
- Thrombocytopenia, Neonate, PFA-100, Neo-BAT, Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- Apr 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 25 Feb 2015 (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.
This is a prospective longitudinal study that evaluates Platelet Function Analyzer-100 (PFA-100) CT-ADPs (closure time-ADP) and incidence of bleeding using the Neonatal Bleeding Assessment Tool - Neo-BAT in preterm neonates <32 weeks gestational age or with a birth weight <1500 grams and with different degrees of thrombocytopenia.
The investigators hypothesized that PFA-100 CT-ADP, a global in vitro test of primary hemostasis, will be a better predictor of clinical bleeding in neonates than platelet count alone. A bleeding risk assessment marker could help physicians more accurately determine the risk/benefit ratio of platelet transfusions, guiding platelet transfusion decisions in neonates with thrombocytopenia.
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
- Patients admitted to the Neonatal Intensive Care Unit who are <32 weeks gestation or with a birth weight <1500 grams.
Key inclusion criteria (3 listed)
- <32 weeks gestation or with a birth weight <1500 grams;
- Have confirmed moderate-to-severe thrombocytopenia, defined as a platelet count <100x109/L;
- Have a parent/guardian willing to comply with the protocol and provide written informed consent.
Key exclusion criteria (3 listed)
- Are not expected to survive by the Attending Neonatologist;
- Are thought to have a congenital thrombocytopenia or platelet dysfunction, based on family history or clinical presentation (e.g. associated congenital malformations, platelet morphology);
- Have a major chromosomal anomaly such as Trisomy 13, 18, or 21.
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
Neo-BAT score (Neo-BAT: Neonatal Bleeding Assessment Tool)
Time frame: study period: 5 days
The NeoBAT is a simple, reliable and objective tool for the standardized assessment of bleeding in neonates, which was developed by an international team of experts based on the World Health Organization bleeding score for adults.
1 secondary outcome
Number of thrombotic events
Time frame: up to post-conceptional age 36 weeks
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 17 Nov 2017.
- Background: PubMed 24094764Deschmann E, Sola-Visner M, Saxonhouse MA. Primary hemostasis in neonates with thrombocytopenia. J Pediatr. 2014 Jan;164(1):167-72. doi: 10.1016/j.jpeds.2013.08.037. Epub 2013 Oct 3.
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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.
Emoke Deschmann, M.D., M.M.Sc. principal investigator
Department of Women's and Children's Health, Karolinska Institutet
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytopenia, run by Karolinska Institutet at 2 sites in 2 countries.
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 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Sweden. 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?
Neo-BAT score (Neo-BAT: Neonatal Bleeding Assessment Tool) (time frame: study period: 5 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 NCT02371330, which also lists 1 linked publication.
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 17 Nov 2017.