Coagulation Disorder, BloodNCT03149250
Characteristics of Primary and Plasmatic Hemostasis in Preeclampsia
An observational study of Coagulation Disorder, Blood and Platelet Function, run by Goethe University.
Trial summary
The study aims to investigate the impact of preeclampsia on hemostasis. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Coagulation Disorder, Blood, Platelet Function
- What is being tested?
- Aggregometry, Monitoring of plasmatic hemostasis
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2017to 1 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Adult
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
Who may be able to join
- Platelet count > 100 / nll
- In study group and control group 1: Week of Pregnancy: 35-40
- in control group 2: healthy, not pregnant woman
Who cannot join
- Hereditary coagulopathy
- Missing content of the patient / proband
- Eclampsia
- HELLP syndrome
- CRP > 1 mg/dl
- Fever (> 38°C)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Characteristics of Primary and Plasmatic Hemostasis in Preeclampsia - a Cross-sectional Study
The study aims to investigate the impact of preeclampsia on hemostasis.
Read the 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.
- Conditions
- Coagulation Disorder, Blood, Platelet Function
- Being tested
- Aggregometry, Monitoring of plasmatic hemostasis
- Keywords
- Aggregometry
- Medical subject headings
- Blood Coagulation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aggregometry, Monitoring of plasmatic hemostasisDiagnostic test
Multiple Electrode Aggregometry using the Multiplate system Coagulation factor analyses (FXIII, FVIII, vWF) Parameters of conventional coagulation testing (aPTT, INR, Platelet count)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Aggregometry, Monitoring of plasmatic hemostasis | |
| 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 Receives: Diagnostic Test: Aggregometry, Monitoring of plasmatic hemostasis | |
| 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. Receives: Diagnostic Test: Aggregometry, Monitoring of plasmatic hemostasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the aggregation curve in the ADPtest of the Multiple Electrode Aggregometry
ADP induced platelet aggregation
Measured: Between 35th and 40th week of pregnancy; in control group 2 (not pregnant) within 1 week after inclusion into the study
Secondary outcomes (3)
Area under the aggregation curve in the ASPItest of the Multiple Electrode Aggregometry
Arachidonic acid induced platelet aggregation
Measured: 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
Measured: 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)
Measured: Between 35th and 40th week of pregnancy; in control group 2 (not pregnant) within 1 week after inclusion into the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start1 Sep 2017 (estimated)
- Primary completion31 Dec 2017 (estimated)
- Study completion1 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coagulation Disorder, BloodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian F. Weber, MD, Cooperative Weichteilsarkom Study Group
- Investigators
- Christian F Weber, MD, PhD, Principal investigator, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149250
- Sponsor's protocol ID
- Hemostasis_Preeclampsia
- Status last verified
- Aug 2017
- First submitted
- 3 May 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Primary and Plasmatic Hemostasis in Preeclampsia - a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03149250
- Acronym / sponsor ID
- Hemostasis_Preeclampsia
- Conditions
- Coagulation Disorder, Blood, Platelet Function
- Keywords
- Aggregometry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 1 Feb 2018 (estimated)
- First posted
- 11 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to investigate the impact of preeclampsia on 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pregnant Preeclampsia | – | Diagnostic Test: Aggregometry, Monitoring of plasmatic hemostasisPregnant 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 |
| Pregnant No-Preeclampsia | – | Diagnostic Test: Aggregometry, Monitoring of plasmatic hemostasisControl 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 |
| Not Pregnant | – | Diagnostic Test: Aggregometry, Monitoring of plasmatic hemostasisControl group 2 Healthy and not pregnant control group Intervention: Aggregometry, Monitoring of plasmatic hemostasis: Aggregometry and conventional coagulation testing after blood sampling. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- 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
Key inclusion criteria (3 listed)
- Platelet count > 100 / nll
- In study group and control group 1: Week of Pregnancy: 35-40
- in control group 2: healthy, not pregnant woman
Key exclusion criteria (6 listed)
- Hereditary coagulopathy
- Missing content of the patient / proband
- Eclampsia
- HELLP syndrome
- CRP > 1 mg/dl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aggregometry, Monitoring of plasmatic hemostasisMultiple Electrode Aggregometry using the Multiplate system Coagulation factor analyses (FXIII, FVIII, vWF) Parameters of conventional coagulation testing (aPTT, INR, Platelet count) | Diagnostic test | Not Pregnant, Pregnant No-Preeclampsia, Pregnant Preeclampsia |
Primary outcome
Area under the aggregation curve in the ADPtest of the Multiple Electrode Aggregometry
Time frame: 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
3 secondary outcomes
Area under the aggregation curve in the ASPItest of the Multiple Electrode Aggregometry
Time frame: 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
Time frame: 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
Time frame: Between 35th and 40th week of pregnancy; in control group 2 (not pregnant) within 1 week after inclusion into the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian F Weber, MD, PhD principal investigator
Goethe University
Questions about this trial
What is this clinical trial studying?
An observational study of Coagulation Disorder, Blood and Platelet Function, run by Goethe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian F Weber, MD, PhD (+49 69 6301 5514, christian.weber@kgu.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the aggregation curve in the ADPtest of the Multiple Electrode Aggregometry (time frame: Between 35th and 40th week of pregnancy; in control group 2 (not pregnant) within 1 week after inclusion into the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.