Fibrinogen as a Surrogate for Global Haemostasis in Plasma Exchange

Terminated

• Conditions: Clotting Disorder Due to Plasma Exchange Therapy; Humoral Rejection After Kidney Transplantation

• Registration Number: NCT02095821
• Lead Sponsor: Hannover Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-27
• Study First Submitted QC: 2014-03-21
• Study First Posted: 2014-03-26
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-16
• Last Update Posted: 2020-04-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hannover Medical School; 🇩🇪 Hannover, Germany