Characteristics of Primary and Plasmatic Hemostasis in Preeclampsia

Characteristics of Primary and Plasmatic Hemostasis in Preeclampsia - a Cross-sectional Study

The study aims to investigate the impact of preeclampsia on hemostasis.

Study Overview

• Status: Unknown
• Conditions: Platelet Function; Coagulation Disorder, Blood
• Intervention / Treatment: Diagnostic test: Aggregometry, Monitoring of plasmatic hemostasis

Detailed Description

In comparison to healthy pregnant women and non-pregnant woman, this study analyses parameters of primary hemostasis and plasmatic coaguation in preeclamptic pregnant woman. Detailed analyses of the platelet function is performed using the Multiple Electrode Aggregometry, detailed analyses of the plasmatic coagulation syste is performed by isolated coaguation factor analyses and conventional coagulation analyses.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Christian F Weber, MD, PhD; Phone Number: +49 69 6301 5514; Email: christian.weber@kgu.de
• Study Contact Backup: Name: Niels Loechelt, MD; Phone Number: +49 69 6301 5514; Email: niels.loechelt@kgu.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Pregnant patients suffering from preeclampsia, n = 20

Control group 1: Healthy pregnant patients, not suffering from preeclampsia, n=20

Control group 2: Healthy woman (age between 18 and 40y) that are not pregnant

Description

Inclusion Criteria:

• Platelet count > 100 / nll
• In study group and control group 1: Week of Pregnancy: 35-40
• in control group 2: healthy, not pregnant woman

Exclusion Criteria:

• Hereditary coagulopathy
• Missing content of the patient / proband
• Eclampsia
• HELLP syndrome
• CRP > 1 mg/dl
• Fever (> 38°C)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant Preeclampsia; Pregnant between 35th and 40th week of pregnancy Preeclampisa Intervention: Aggregometry, Monitoring of plasmatic hemostasis: Aggregometry and conventional coagulation testing after blood sampling in the context of routinely performed blood sampling	Diagnostic test: Aggregometry, Monitoring of plasmatic hemostasis; Multiple Electrode Aggregometry using the Multiplate system Coagulation factor analyses (FXIII, FVIII, vWF) Parameters of conventional coagulation testing (aPTT, INR, Platelet count)
Pregnant No-Preeclampsia; Control Group 1 Pregnant between 35th and 40th week of pregnancy No Preeclampsia Healthy Intervention: Aggregometry, Monitoring of plasmatic hemostasis: Aggregometry and conventional coagulation testing after blood sampling in the context of routinely performed blood sampling	Diagnostic test: Aggregometry, Monitoring of plasmatic hemostasis; Multiple Electrode Aggregometry using the Multiplate system Coagulation factor analyses (FXIII, FVIII, vWF) Parameters of conventional coagulation testing (aPTT, INR, Platelet count)
Not Pregnant; Control group 2 Healthy and not pregnant control group Intervention: Aggregometry, Monitoring of plasmatic hemostasis: Aggregometry and conventional coagulation testing after blood sampling.	Diagnostic test: Aggregometry, Monitoring of plasmatic hemostasis; Multiple Electrode Aggregometry using the Multiplate system Coagulation factor analyses (FXIII, FVIII, vWF) Parameters of conventional coagulation testing (aPTT, INR, Platelet count)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the aggregation curve in the ADPtest of the Multiple Electrode Aggregometry	ADP induced platelet aggregation	Between 35th and 40th week of pregnancy; in control group 2 (not pregnant) within 1 week after inclusion into the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the aggregation curve in the ASPItest of the Multiple Electrode Aggregometry	Arachidonic acid induced platelet aggregation	Between 35th and 40th week of pregnancy; in control group 2 (not pregnant) within 1 week after inclusion into the study
Area under the aggregation curve in the TRAPtest of the Multiple Electrode Aggregometry	Thrombin induced platelet aggregation	Between 35th and 40th week of pregnancy; in control group 2 (not pregnant) within 1 week after inclusion into the study
Parameters of plasmatic coagulation system	von Willebrand Factor, Factor VIII, Factor XIII, parameter of conventional coagulation testing (apTT, INR, platelet count, Fibrinogen)	Between 35th and 40th week of pregnancy; in control group 2 (not pregnant) within 1 week after inclusion into the study

Collaborators and Investigators

• Sponsor: Goethe University
• Investigators: Principal Investigator: Christian F Weber, MD, PhD, Goethe University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2017
• Primary Completion (Anticipated): December 31, 2017
• Study Completion (Anticipated): February 1, 2018

Study Registration Dates

• First Submitted: May 3, 2017
• First Submitted That Met QC Criteria: May 10, 2017
• First Posted (Actual): May 11, 2017

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 17, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Aggregometry
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Pregnancy Complications; Hypertension, Pregnancy-Induced; Hemostatic Disorders; Blood Coagulation Disorders; Pre-Eclampsia; Coagulants; Hemostatics
• Other Study ID Numbers: Hemostasis_Preeclampsia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No