Stratifying Risk for Intracerebral Haemorrhage

NCT ID: NCT04140812

Last Updated: 2019-10-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-21
• Study Completion Date: 2020-09-30

Brief Summary

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.

Detailed 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).

Conditions

Preterm Birth; Coagulation Protein Disorders; Coagulation Disorder Neonatal

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Term infants (≥37+0 weeks)

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).

Group Type: ACTIVE_COMPARATOR

mass spectrometry (LC-MS/MS)

Intervention Type: DIAGNOSTIC_TEST

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) for 125 proteins.

Preterm infants (≤32+0 weeks)

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).

Group Type: EXPERIMENTAL

mass spectrometry (LC-MS/MS)

Intervention Type: DIAGNOSTIC_TEST

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) for 125 proteins.

Interventions

mass spectrometry (LC-MS/MS)

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) for 125 proteins.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Maximum Eligible Age: 72 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabian B Fahlbusch, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department for Children- and Adolescent Medicine

Locations

Department of Pediatrics- and Adolescent Medicine, FAU Erlangen-Nuremberg

Erlangen, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Fahlbusch

Role: CONTACT

fabian.fahlbusch@uk-erlangen.de

+49 9131 8533118

Ferdinand Knieling, M.D.

Role: CONTACT

ferdinand.knieling@uk-erlangen.de

+49 9131 8533118

Facility Contacts

Fabian Fahlbusch

Role: primary

fabian.fahlbusch@uk-erlangen.de

+49 9131 85 33118

Ferdinand Knieling

Role: backup

ferdinand.knieiling@uk-erlangen.de

+49 9131 85 33118

Other Identifiers

294_19B

Identifier Type: -

Identifier Source: org_study_id