Stratifying Risk for Intracerebral Haemorrhage (NEW_STRATEGI)

University of Erlangen-Nürnberg Medical School

Status: Unknown

Conditions: Coagulation Disorder Neonatal; Coagulation Protein Disorders; Preterm Birth

Treatments: Diagnostic Test: mass spectrometry (LC-MS/MS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04140812

294_19B

Details and patient eligibility

About

This study aims to investigates the role of gestational age on the prevalence of coagulation factors and components of the complement system in preterm- (≤32+0 weeks) and term neonates (≥37+0 weeks) and their role for the development of brain hemorrhage.

Full description

The occurrence of brain hemorrhage (germinal matrix hemorrhage and intraventricular hemorrhage, GM-IVH) in newborns, especially in preterm infants, is one of the most important prognostic factors for mortality and morbidity (especially for later neurological development) in this collective. The risk of high-grade bleeding in extremely premature infants (22 weeks) is approx. 38% and decreases to approx. 7% by the 28th week. The total frequency of GM-IVH is around 8% in gestational weeks 23 to 31, with each additional gestational week reducing the risk by 3.5%. The etiopathology of brain hemorrhage is complex and involves both environmental and genetic factors. Recent studies particularly suggest an involvement of the immature coagulation system in preterm neonates. Global coagulation parameters, such as the International Normalized Ratio (INR), have already been associated with an increased risk of bleeding, but rarely show fluctuations outside the norm. Furthermore, polymorphisms in the area of individual coagulation factors as well as other inflammatory and vascular individual components of coagulation, are associated with an increased risk of bleeding. Mass spectrometry has long been used for the analysis of biological samples and has developed into an indispensable tool for proteomics research. The study aims to establish the mass spectrometric detection of a total of 125 blood plasma factors containing the individual components of the coagulation system and the complement system. The method enables quantitative detection of the coagulation system with even the smallest sample quantities, so that sampling can be combined with routine measures, particularly in the field of neonatology. This pilot study to compare the compositional differences regarding coagulation factors and the complement system in relation to the gestational age (i.e. preterm ≤32+0 weeks vs. term neonates ≥37+0 weeks).

Enrollment: 50 estimated patients

Sex: All

Ages: Under 72 hours old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• medical indication (newborn screening) and informed consent for blood drawing

Exclusion criteria

• clinical evidence of infection
• clinical evidence of hyperbilirubinemia
• Preeclampsia (PE), HELLP-syndrome, intrauterine growth restriction (IUGR) and PE+IUGR

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Term infants (≥37+0 weeks)

Active Comparator group

Description:

Blood collection (5 drops) during newborn-screening (36-72h after birth) or postnatal hospitalization (\<36h after birth). The blood sample will then be examined using mass spectrometry (LC-MS/MS).

Treatment:

Diagnostic Test: mass spectrometry (LC-MS/MS)

Preterm infants (≤32+0 weeks)

Experimental group

Description:

Blood collection (5 drops) during newborn-screening (36-72h after birth) or postnatal hospitalization (\<36h after birth). The blood sample will then be examined using mass spectrometry (LC-MS/MS).

Treatment:

Diagnostic Test: mass spectrometry (LC-MS/MS)