Fibrinogen as a Surrogate for Global Haemostasis in Plasma Exchange

Clotting Disorder Due to Plasma Exchange Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02095821
• Other study ID #: FIB-2110-2014
• Status: Terminated
• Start date: February 2014
• Est. completion date: October 2019

Study information

• Verified date: April 2020
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Clotting Disorder Due to Plasma Exchange Therapy
• Hemostatic Disorders
• Humoral Rejection After Kidney Transplantation

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

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