Fibrinogen as a Surrogate for Global Haemostasis in Plasma Exchange

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02095821

Enrollment

Registered

2014-03-26

Start date

2014-02-28

Completion date

2019-10-31

Last updated

2020-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clotting Disorder Due to Plasma Exchange Therapy, Humoral Rejection After Kidney Transplantation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Thrombin clotting time	Baseline, daily measurement until hospital discharge (avarage hospital stay: 10 days)	Daily measurement after initiation of plasma exchange therapy until treatment course is finished

Countries

Germany

Outcome results