Characteristics of Primary and Plasmatic Hemostasis in Preeclampsia

Platelet Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03149250
• Other study ID #: Hemostasis_Preeclampsia
• Status: Not yet recruiting
• Phase: N/A
• First received: May 3, 2017
• Last updated: August 17, 2017
• Start date: September 1, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: August 2017
• Source: Goethe University
• Contact: Christian F Weber, MD, PhD
• Phone: +49 69 6301 5514
• Email: christian.weber[@]kgu.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 1, 2018
• Est. primary completion date: December 31, 2017
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulation Disorder, Blood
• Hemostatic Disorders
• Platelet Function
• Pre-Eclampsia

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Goethe University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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