High Sensitive Troponin T (hsTnT) and Copeptin as Prognos... | NCT01335815

Studies
High Sensitive Troponin T (hsTnT) and Copeptin as Prognostic Parameters in Patients With Elective Total Endoprosthesis

NCT01335815

Sponsor

Heidelberg University

Status

Unknown status

Last Update Posted

Apr 14, 2011Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Perioperative Myocardial Infarctions
Pulmonary Embolism

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 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Mar 2012Estimated

Completion Date

Mar 2013Estimated

First Submitted Date

Apr 13, 2011

First Submission Date that Met QC Criteria

Apr 13, 2011

First Posted Date

Apr 14, 2011Estimated

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 13, 2011

Last Update Posted Date

Apr 14, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Summary: The purpose of the study is to prove if the biomarker high sensitive troponin T (hsTnT) and the biomarker of endogenous stress copeptin can serve as surrogate parameter of prognosis in patients with elective knee and hip total endoprosthesis.

Detailed Description

Consecutively, high sensitive troponin T and copeptin will be measured in all patients with elective knee and hip endoprosthesis in the orthopedic department of the University of Heidelberg. The blood is taken during the routine blood testes if possible, on admission and the days 1-4 following the operation. Usual baseline characteristics are taken as well as usual blood results (hb, cholesterol and so on). Primary endpoint is the detection of perioperative myocardial infarction and pulmonary embolism.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Label	Type	Description	Intervention Names
elective knee and limb endoprothesis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of perioperative myocardial infarction and pulmonary embolism		Until 96h after operation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Consecutive patients with elective knee and hip endoprosthesis

Exclusion Criteria:

Not willing or not able to take part in the observational trial
No written inform consent

Accepts Healthy Volunteers

Yes

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

all patients with elective knee and hip endoprothesis

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
evangelos Giannitsis, Prof. Dr.	Contact	0049-6221-56-38686		Evangelos_Giannitsis@med.uni-heidelberg.de

Overall Officials

Name	Affiliation	Role
Evangelos Giannitsis, Prof. Dr.	Heidelberg University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Heidelberg	Recruiting	Heidelberg	Baden-Wurttemberg	69120	Germany

Condition Browse Module

MeSH Terms

ID	Term
D011655	Pulmonary Embolism

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D004617	Embolism
D016769	Embolism and Thrombosis

Browse Leaves

Not provided

Browse Branches

Not provided