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

April 13, 2011 updated by: Heidelberg University

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

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

all patients with elective knee and hip endoprothesis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
elective knee and limb endoprothesis

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Investigators

  • Principal Investigator: Evangelos Giannitsis, Prof. Dr., Heidelberg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

April 13, 2011

First Submitted That Met QC Criteria

April 13, 2011

First Posted (Estimate)

April 14, 2011

Study Record Updates

Last Update Posted (Estimate)

April 14, 2011

Last Update Submitted That Met QC Criteria

April 13, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TnT hs 3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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