Fibrinogen as a Surrogate for Global Haemostasis in Plasm... | NCT02095821

Studies
Fibrinogen as a Surrogate for Global Haemostasis in Plasma Exchange

NCT02095821

Sponsor

Hannover Medical School

Status

Terminated

Last Update Posted

Apr 20, 2020Actual

Enrollment

2Actual

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was stopped due to recruitment failure

Expanded Access Info

Start Date

Feb 2014Actual

Primary Completion Date

Oct 2019Actual

Completion Date

Oct 2019Actual

First Submitted Date

Feb 27, 2014

First Submission Date that Met QC Criteria

Mar 21, 2014

First Posted Date

Mar 26, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2020

Last Update Posted Date

Apr 20, 2020Actual

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Label	Type	Description	Intervention Names
Humoral rejection, TPE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Tertiary hospital patients after kidney transplantation, humoral rejection

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sascha David, MD	Medical School Hannover	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hannover Medical School		Hanover			Germany