Skip to main content
Clinical Trials/NCT02095821
NCT02095821
Terminated
Not Applicable

Observational Study of Fibrinogen as a Surrogate for Global Haemostasis in Plasma Exchange Therapy

Hannover Medical School1 site in 1 country2 target enrollmentFebruary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Clotting Disorder Due to Plasma Exchange Therapy
Sponsor
Hannover Medical School
Enrollment
2
Locations
1
Primary Endpoint
Thrombin clotting time
Status
Terminated
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
October 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Julius Schmidt

MD

Hannover Medical School

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Thrombin clotting time

Time Frame: Baseline, daily measurement until hospital discharge (avarage hospital stay: 10 days)

Daily measurement after initiation of plasma exchange therapy until treatment course is finished

Study Sites (1)

Loading locations...

Similar Trials