Fibrinogen as a Surrogate for Global Haemostasis in Plasma Exchange
April 16, 2020 updated by: Julius Schmidt, Hannover Medical School
Observational Study of Fibrinogen as a Surrogate for Global Haemostasis in Plasma Exchange Therapy
Plasma exchange is a frequently used therapy in many antibody-mediated disorders, such as humoral rejection after kidney transplantation.
Treatment frequency is adjusted to daily measured fibrinogen blood levels to prevent bleeding complications.
However, data about the correlation of fibrinogen blood levels and function of the coagulation system during plasma exchange therapy is scarce.
In the present study we examine blood fibrinogen levels and coagulation factors as well as thrombin clotting time in patients under plasma exchange therapy.
Study Overview
Status
Terminated
Study Type
Observational
Enrollment (Actual)
2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hannover, Germany
- Hannover Medical School
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Tertiary hospital patients after kidney transplantation, humoral rejection
Description
Inclusion Criteria:
- plasma exchange therapy due to humoral rejection after kidney transplantation
Exclusion Criteria:
- hereditary coagulopathy
- chronic liver disease (Child C)
- therapeutic anticoagulation
- malnutrition (BMI<17.5)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Humoral rejection, TPE
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Thrombin clotting time
Time Frame: Baseline, daily measurement until hospital discharge (avarage hospital stay: 10 days)
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Daily measurement after initiation of plasma exchange therapy until treatment course is finished
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Baseline, daily measurement until hospital discharge (avarage hospital stay: 10 days)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sascha David, MD, Medical School Hannover
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2014
Primary Completion (Actual)
October 1, 2019
Study Completion (Actual)
October 1, 2019
Study Registration Dates
First Submitted
February 27, 2014
First Submitted That Met QC Criteria
March 21, 2014
First Posted (Estimate)
March 26, 2014
Study Record Updates
Last Update Posted (Actual)
April 20, 2020
Last Update Submitted That Met QC Criteria
April 16, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FIB-2110-2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.