Neonatal ThrombocytopeniaNEOHAT-2NCT04598750
The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia
An observational study of Neonatal Thrombocytopenia and Bleeding, run by Karolinska Institutet at 8 sites in 3 countries.
Trial summary
This is a prospective observational study designed to evaluate Immature Platelet Fraction or Immature Platelet Count and Platelet Function Analyzer-100/200 Closure Time-ADP (in vitro bleeding time) as markers of bleeding risk in thrombocytopenic preterm neonates admitted to the Neonatal Intensive Care Unit. Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Neonatal Thrombocytopenia, Bleeding
- How many people
- 250 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 15 Jun 2021to 31 Dec 2025
- 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 1 day and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: - Infants will be eligible for study if they have a gestational age <32 weeks and a birth weight ≥500 grams; and have a platelet count <100 x 109/L.
Who may be able to join
- Have a gestational age <32 weeks and a birth weight ≥500 grams;
- Have a platelet count <100 x 109/L; and
- Have a parent/guardian willing to provide written informed consent.
Who cannot join
- Are not expected to survive for >24 hours by the Attending Neonatologist;
- Are thought to have a familial thrombocytopenia or platelet dysfunction, based on family history or clinical presentation (associated congenital malformations, platelet morphology).
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
United States4 sites, 4 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Martha Sola-Visner, MD, martha.sola-visner@childrens.harvard.edu
- Not yet recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Martha Sola-Visner, MD, martha.sola-visner@childrens.harvard.edu
- Not yet recruiting
Intermountain Medical Center
Murray, Utah, 84107
Robert Christensen, MD, robert.christensen@hsc.utah.edu
- Not yet recruiting
Utah Valley Hospital
Provo, Utah, 84604
Robert Christensen, MD, robert.christensen@hsc.utah.edu
Netherlands2 sites, 2 recruiting
- Not yet recruiting
Amsterdam University Medical Centre
Amsterdam
Wes Onland, MD, PhD, w.onland@amsterdamumc.nl
- Not yet recruiting
Leiden University Medical Center
Leiden
Enrico Lopriore, MD, PhD, e.lopriore@lumc.nl
Sweden2 sites, 2 recruiting
- Recruiting
Karolinska University Hospital Huddinge campus
Huddinge
Emoke Deschmann, MD PhD MMSc, +46735395575, emoke.deschmann@sll.se
- Recruiting
Karolinska University Hospital Solna campus, Astrid Lindgren Children's Hospital
Stockholm
Emoke Deschmann, MD PhD MMSc, +46735395575, emoke.deschmann@sll.se
About this study
Official title: The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study-2
This is a prospective observational study designed to evaluate Immature Platelet Fraction or Immature Platelet Count and Platelet Function Analyzer-100/200 Closure Time-ADP (in vitro bleeding time) as markers of bleeding risk in thrombocytopenic preterm neonates admitted to the Neonatal Intensive Care Unit.
Read the detailed description
Thrombocytopenia is a known risk factor for clinically significant bleeding in neonates. However, there is a poor correlation between degree of thrombocytopenia and bleeding risk. A better marker of bleeding risk suitable for use in neonates could help physicians more accurately determine the risk/benefit ratio of platelet transfusions, guiding platelet transfusion decisions, and potentially protecting vulnerable infants from exposure to unnecessary transfusion-related risks. The investigators recently found that the Platelet Function Analyzer (PFA) Closure Time-Collagen/ADP (CT-ADP) was a better marker of bleeding than the platelet count in preterm neonates. However, the CT-ADP requires 0.8 mL blood limiting its potential widespread use. The Immature Platelet Fraction (IPF) is a new laboratory marker measuring the % newly released and more active platelets, measured from the same sample as the platelet count. This is a prospective observational study designed to evaluate IPF as marker of bleeding risk in thrombocytopenic neonates admitted to the Neonatal Intensive Care Unit, compared to platelet counts alone. And also, to validate the previously found association between PFA-100/200 CT-ADP and bleeding in a bigger cohort, to compare the IPF with the PFA-100/200 CT-ADP as bleeding predictors and to assess whether the PFA-100/200 CT-ADP combined with the IPF is able to predict bleeding in thrombocytopenic preterm neonates.
- Conditions
- Neonatal Thrombocytopenia, Bleeding
- Medical subject headings
- Thrombocytopenia, Neonatal Alloimmune, Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
NeoBAT score
NeoBAT scores will include any bleeding since the last platelet count or over the prior 24 hours, whichever is shortest. This will serve to correlate bleeding scores (NeoBAT) with platelet counts, IPF% and IPC, PFA-100/200 CT-ADP, and to quantify changes in response to platelet transfusions. The scale is 1 to 4 with 1 being Minor Hemorrhage and 4 being Severe Hemorrhage.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start15 Jun 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, National Heart, Lung, and Blood Institute (NHLBI), Boston Children's Hospital, Harvard Medical School (HMS and HSDM), Region Stockholm, The Swedish Society of Medicine
- Responsible party
- Principal investigator, Emoke Deschmann, Karolinska Institutet
- Investigators
- Emöke Deschmann, MD, PhD, Principal investigator, Karolinska InstitutetRobert Christensen, MD, Study chair, University of Utah Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598750
- Sponsor's protocol ID
- TRF15483
- Other IDs
- 2P01HL046925-21A1
- Acronym
- NEOHAT-2
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2020
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study-2
- ClinicalTrials.gov ID
- NCT04598750
- Acronym / sponsor ID
- NEOHAT-2 / TRF15483
- Conditions
- Neonatal Thrombocytopenia, Bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, National Heart, Lung, and Blood Institute (NHLBI), Boston Children's Hospital, Harvard Medical School (HMS and HSDM), Region Stockholm, The Swedish Society of Medicine
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Oct 2020 (actual)
- 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 observational study designed to evaluate Immature Platelet Fraction or Immature Platelet Count and Platelet Function Analyzer-100/200 Closure Time-ADP (in vitro bleeding time) as markers of bleeding risk in thrombocytopenic preterm neonates admitted to the Neonatal Intensive Care Unit.
Detailed description
Thrombocytopenia is a known risk factor for clinically significant bleeding in neonates. However, there is a poor correlation between degree of thrombocytopenia and bleeding risk. A better marker of bleeding risk suitable for use in neonates could help physicians more accurately determine the risk/benefit ratio of platelet transfusions, guiding platelet transfusion decisions, and potentially protecting vulnerable infants from exposure to unnecessary transfusion-related risks. The investigators recently found that the Platelet Function Analyzer (PFA) Closure Time-Collagen/ADP (CT-ADP) was a better marker of bleeding than the platelet count in preterm neonates. However, the CT-ADP requires 0.8 mL blood limiting its potential widespread use. The Immature Platelet Fraction (IPF) is a new laboratory marker measuring the % newly released and more active platelets, measured from the same sample as the platelet count. This is a prospective observational study designed to evaluate IPF as marker of bleeding risk in thrombocytopenic neonates admitted to the Neonatal Intensive Care Unit, compared to platelet counts alone. And also, to validate the previously found association between PFA-100/200 CT-ADP and bleeding in a bigger cohort, to compare the IPF with the PFA-100/200 CT-ADP as bleeding predictors and to assess whether the PFA-100/200 CT-ADP combined with the IPF is able to predict bleeding in thrombocytopenic preterm neonates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- - Infants will be eligible for study if they have a gestational age <32 weeks and a birth weight ≥500 grams; and have a platelet count <100 x 109/L.
Key inclusion criteria (3 listed)
- Have a gestational age <32 weeks and a birth weight ≥500 grams;
- Have a platelet count <100 x 109/L; and
- Have a parent/guardian willing to provide written informed consent.
Key exclusion criteria (2 listed)
- Are not expected to survive for >24 hours by the Attending Neonatologist;
- Are thought to have a familial thrombocytopenia or platelet dysfunction, based on family history or clinical presentation (associated congenital malformations, platelet morphology).
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
NeoBAT score
Time frame: 24 hours
NeoBAT scores will include any bleeding since the last platelet count or over the prior 24 hours, whichever is shortest. This will serve to correlate bleeding scores (NeoBAT) with platelet counts, IPF% and IPC, PFA-100/200 CT-ADP, and to quantify changes in response to platelet transfusions. The scale is 1 to 4 with 1 being Minor Hemorrhage and 4 being Severe Hemorrhage.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
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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.
Emöke Deschmann, MD, PhD principal investigator
Karolinska Institutet
Robert Christensen, MD study chair
University of Utah Medical Center
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Thrombocytopenia and Bleeding, run by Karolinska Institutet at 8 sites in 3 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 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: status not confirmed, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Netherlands, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emöke Deschmann, MD, PhD (+46 73 539 5575, emoke.deschmann@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NeoBAT score (time frame: 24 hours). 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 9 Oct 2024.