Characteristics of Primary and Plasmatic Hemostasis in Preeclampsia

• Sponsor: Goethe University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03149250
• Collaborator: (none)
• Enrollment: 60
• Anticipated Duration (Months): 5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Coagulation Disorder, Blood; Platelet Function	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 Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Characteristics of Primary and Plasmatic Hemostasis in Preeclampsia - a Cross-sectional Study
• Anticipated Study Start Date: Sep 1, 2017
• Anticipated Primary Completion Date: Dec 31, 2017
• Anticipated Study Completion Date: Feb 1, 2018

Arms and Interventions

Arm	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)

Outcome Measures

Primary Outcome Measures

1. Area under the aggregation curve in the ADPtest of the Multiple Electrode Aggregometry [Between 35th and 40th week of pregnancy; in control group 2 (not pregnant) within 1 week after inclusion into the study]

   ADP induced platelet aggregation

Secondary Outcome Measures

1. Area under the aggregation curve in the ASPItest of the Multiple Electrode Aggregometry [Between 35th and 40th week of pregnancy; in control group 2 (not pregnant) within 1 week after inclusion into the study]

   Arachidonic acid induced platelet aggregation

2. Area under the aggregation curve in the TRAPtest of the Multiple Electrode Aggregometry [Between 35th and 40th week of pregnancy; in control group 2 (not pregnant) within 1 week after inclusion into the study]

   Thrombin induced platelet aggregation

3. Parameters of plasmatic coagulation system [Between 35th and 40th week of pregnancy; in control group 2 (not pregnant) within 1 week after inclusion into the study]

   von Willebrand Factor, Factor VIII, Factor XIII, parameter of conventional coagulation testing (apTT, INR, platelet count, Fibrinogen)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Goethe University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Christian F. Weber, MD, Prof. Dr. med. Christian F. Weber, Cooperative Weichteilsarkom Study Group
• ClinicalTrials.gov Identifier: NCT03149250
• Other Study ID Numbers: Hemostasis_Preeclampsia
• First Posted: May 11, 2017
• Last Update Posted: Aug 22, 2017
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Christian F. Weber, MD, Prof. Dr. med. Christian F. Weber, Cooperative Weichteilsarkom Study Group: Aggregometry
• Additional relevant MeSH terms: Pre-Eclampsia; Hemostatic Disorders; Blood Coagulation Disorders; Hemostatics

Study Results

No Results Posted as of Aug 22, 2017