Characteristics of Primary and Plasmatic Hemostasis in Preeclampsia

NCT ID: NCT03149250

Last Updated: 2017-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-02-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Coagulation Disorder, Blood Platelet Function

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Aggregometry, Monitoring of plasmatic hemostasis

Intervention Type DIAGNOSTIC_TEST

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

Aggregometry, Monitoring of plasmatic hemostasis

Intervention Type DIAGNOSTIC_TEST

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.

Aggregometry, Monitoring of plasmatic hemostasis

Intervention Type DIAGNOSTIC_TEST

Multiple Electrode Aggregometry using the Multiplate system Coagulation factor analyses (FXIII, FVIII, vWF) Parameters of conventional coagulation testing (aPTT, INR, Platelet count)

Interventions

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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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Goethe University

OTHER

Sponsor Role lead

Responsible Party

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Christian F. Weber, MD

Prof. Dr. med. Christian F. Weber

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian F Weber, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Goethe University

Central Contacts

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Christian F Weber, MD, PhD

Role: CONTACT

+49 69 6301 5514

Niels Loechelt, MD

Role: CONTACT

+49 69 6301 5514

Other Identifiers

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Hemostasis_Preeclampsia

Identifier Type: -

Identifier Source: org_study_id

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