Impact of Thrombocytopenia and Platelet Transfusions on Neonatal Bleeding and Inflammation

  • STATUS
    Recruiting
  • End date
    Sep 1, 2024
  • participants needed
    160
  • sponsor
    Boston Children's Hospital
Updated on 1 May 2022

Summary

This is a prospective observational study that was designed with the following two Specific

Aims
  1. To determine whether the Immature Platelet Fraction percentage (IPF%) and the Immature Platelet Count (IPC) are better predictors of bleeding than the platelet count alone in neonates of different gestational and post-conceptional ages and with different etiologies of thrombocytopenia; and
  2. To characterize the effects of neonatal thrombocytopenia and platelet transfusions (PLT Tx) on bleeding and on markers of systemic inflammation, thrombosis, and neutrophil extracellular traps (NET) formation in neonates with different underlying conditions.

Description

This is a prospective observational study designed to contrast the potential positive effects of neonatal platelet transfusion on clinical bleeding vs. their potentially negative effects on NET formation, intravascular thrombosis and elevation of pro-inflammatory cytokines.

Importantly, patients will be consented when they have a platelet count <100 x 109/L, but they will enter study only when the platelet count falls to <50 x 109/L.

After obtaining signed Informed Consent, enrolled infants will undergo the following:

  1. Prospective collection of clinical and laboratory data, including:
  2. Baseline demographic and clinical information from infants and mothers;
  3. Clinical diagnoses at the time of enrollment (if NEC, then Bell's stage) and illness severity (SNAP scores) at the time of diagnosis;
  4. All hemoglobins, hematocrits, PLT counts, IPF% and IPCs obtained during study. An IPF (the PLT equivalent of the reticulocyte count) is automatically run on every thrombocytopenic sample at all participating hospitals, and will provide information regarding mechanism of thrombocytopenia;
  5. All blood culture results, and all markers of liver and renal function;
  6. All PLT, RBC and plasma transfusions, including product characteristics, transfusion times, and volume; and
  7. Neonatal outcomes including IVH (any grade), chronic lung disease (oxygen requirement at 36 wks post-conception), retinopathy of prematurity (any grade), and mortality.

Infants will be followed until resolution of the severe thrombocytopenia (PLT count >50x109/L without PLT Tx x 72 hours), death or discharge, whichever comes first.

2. Study-specific procedures. In addition to the data collected as above, enrolled infants will undergo the following study-specific measurements:

  1. A bleeding score (Neo-BAT, see Appendix) will be obtained by the bedside nurse within 2 hours of every PLT count and IPF% checked. NeoBAT scores will include any bleeding since the last PLT count or over the prior 24 hours, whichever is shortest. This will serve to correlate bleeding scores with PLT counts, and to quantify changes following PLT Tx;
  2. Two optional blood samples will be obtained within 2 hours prior to and 4±2 hours (see below) following the first clinically indicated PLT Tx after enrollment. These 2 study-specific blood samples (0.5-1.0 cc each) will be taken to the study laboratory for a CBC and plasma separation and storage for future measurements of dsDNA and MPO-DNA ELISA, markers of NET formation, TAT complexes (markers of intravascular coagulation), and for a panel of serum cytokines/vascular injury markers (IFNɣ, IL-6, IL-8, IL-10, IL-17, IL-18, TNFα/β, IP-10, MCP-1, ICAM, VCAM, and VEGF) by Luminex;
  3. In addition, left-over plasma samples from clinical tests will be collected daily from the clinical laboratory, aliquoted, and frozen for future cytokine measurements, as we did to generate the preliminary data for this study.

Details
Condition Neonatal Thrombocytopenia
Clinical Study IdentifierNCT03848923
SponsorBoston Children's Hospital
Last Modified on1 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Have a post-menstrual age between 23 and 44 weeks
Have a PLT count <100 x 109/L; and
Have a parent/guardian willing to provide written informed consent

Exclusion Criteria

Are not expected to survive for >5 days by the Attending Neonatologist
Are thought to have a congenital thrombocytopenia or platelet dysfunction, based on family history or clinical presentation (e.g. congenital malformations, platelet morphology); or
Are on extracorporeal membrane oxygenation (ECMO)
Importantly, patients will be consented when they have a platelet count <100 x 109/L, but
they will enter study only when the platelet count falls to <50 x 109/L
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note