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Monitoring Outcome in Neonatal Thrombocytopenia (MONET)

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ClinicalTrials.gov Identifier: NCT03110887
Recruitment Status : Completed
First Posted : April 12, 2017
Last Update Posted : August 15, 2017
Sponsor:
Collaborators:
Leiden University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Information provided by (Responsible Party):
Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research

Brief Summary:

Rationale: Approximately 10% of neonates admitted to neonatal intensive care units develop a major hemorrhage. In an attempt to avert this severe complication various preventive measures have been implemented. One of these is the transfusion of platelets to premature neonates with low platelet counts. However, this practice is not supported by scientific evidence. Most neonates with low platelet counts never experience a major bleeding and platelet transfusions may carry risks of volume overload or infection. Therefore, it is important to treat only those patients that truly benefit from this intervention. We urgently need a scientifically based tool to predict which premature neonates are at risk for major bleeding. A few prediction models do exist, but these only allow assessment of bleeding risk at baseline, and do not correct for changes in clinical status during the admission period. We believe that adding this feature to our prediction model will significantly improve our ability to predict bleeding. The prediction model will also be helpful in developing individualized transfusion guidelines as it helps us to predict which neonates would benefit from prophylactic platelet transfusions.

Main objective: to develop a dynamic prediction model for bleeding in preterm neonates with low platelet counts.

Study design: retrospective observational cohort study.

Study population: neonates with a gestational age at birth of < 34 weeks admitted to a neonatal intensive care unit (NICU), with a thrombocyte count of less than 50x109/L will be included.

Assessments: only data generated through standard care will be collected. This includes platelet counts, cerebral ultrasounds, information about bleeding and transfusions, and multiple clinical variables.

Main study endpoint: major bleeding during admission

Statistical analyses: dynamic prediction model using landmarking.


Condition or disease
Neonatal Thrombocytopenia Intraventricular Hemorrhage Platelet Transfusion

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Monitoring Outcome in Neonatal Thrombocytopenia
Actual Study Start Date : November 20, 2015
Actual Primary Completion Date : October 21, 2016
Actual Study Completion Date : November 9, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Group/Cohort
Preterm neonate with thrombocytopenia
Preterm neonates (GA<34 weeks) with severe thrombocytopenia



Primary Outcome Measures :
  1. Major hemorrhage [ Time Frame: T0 = time of first platelet count <50. End of study = major bleed, death or discharge. Datacollection between 01-01-2010 and 31-12-2014 ]
    Any type of major bleeding (IVH, pulmonary hemorrhage, gastro-intestinal hemorrhage, etc, according to prespecified definitions)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Admitted to participating neonatal intensive care unit, gestational age >34 weeks.
Criteria

Inclusion Criteria:

  • gestational age <34 weeks at birth
  • platelet count <50x10^9/L

Exclusion Criteria:

  • readmission to NICU (only first admissions are included. Postnatal transfers from non-NICU hospitals are included)
  • major congenital malformations
  • high suspicion of spurious platelet count
  • thrombocytopenia exclusively in the context of exchange transfusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110887


Sponsors and Collaborators
Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
Leiden University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Principal Investigator: Karin Fijnvandraat, MD PhD prof Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Principal Investigator: Enrico Lopriore, MD PhD prof Leiden University Medical Center
Principal Investigator: Anske van der Bom, MD PhD prof Sanquin Blood Supply Foundation, department of clinical transfusion research, Leiden, the Netherlands

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
ClinicalTrials.gov Identifier: NCT03110887     History of Changes
Other Study ID Numbers: PPOC 12-012027
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: August 15, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research:
Dynamic prediction model

Additional relevant MeSH terms:
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Hemorrhage
Thrombocytopenia
Cerebral Hemorrhage
Thrombocytopenia, Neonatal Alloimmune
Pathologic Processes
Blood Platelet Disorders
Hematologic Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Infant, Newborn, Diseases