Monitoring Outcome in Neonatal Thrombocytopenia

NCT03110887 | Completed

• 1 other identifier: PPOC 12-012027
• Study Type: observational
• Target: 700
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neonatal Thrombocytopenia; Intraventricular Hemorrhage; Platelet Transfusion

Keywords

Dynamic prediction model

Outcome Measures

Primary Outcomes (1)

• Major hemorrhage

  Any type of major bleeding (IVH, pulmonary hemorrhage, gastro-intestinal hemorrhage, etc, according to prespecified definitions)

  T0 = time of first platelet count <50. End of study = major bleed, death or discharge. Datacollection between 01-01-2010 and 31-12-2014

Study Arms (1)

Preterm neonate with thrombocytopenia

Preterm neonates (GA\<34 weeks) with severe thrombocytopenia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Admitted to participating neonatal intensive care unit, gestational age \>34 weeks.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research: lead
• Leiden University Medical Center: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator

Related Publications (1)

• Fustolo-Gunnink SF, Fijnvandraat K, Putter H, Ree IM, Caram-Deelder C, Andriessen P, d'Haens EJ, Hulzebos CV, Onland W, Kroon AA, Vijlbrief DC, Lopriore E, van der Bom JG. Dynamic prediction of bleeding risk in thrombocytopenic preterm neonates. Haematologica. 2019 Nov;104(11):2300-2306. doi: 10.3324/haematol.2018.208595. Epub 2019 Feb 28.

  PMID: 30819913 DERIVED

MeSH Terms

Conditions

Thrombocytopenia, Neonatal Alloimmune

Condition Hierarchy (Ancestors)

Thrombocytopenia; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 12, 2017
• Study Start: November 20, 2015
• Primary Completion: October 21, 2016
• Study Completion: November 9, 2016
• Last Updated: August 15, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share