Observational Study of Thrombogenic Properties in 220 Patients With Proximal Femur Fracture (thro-fract15)

April 14, 2021 updated by: Vestre Viken Hospital Trust
Measurement of thrombogenic properties by TEG and MEA and observation of thrombotic events over 2 years in 220 patients with hip fracture.

Study Overview

Status

Terminated

Conditions

Detailed Description

Patients with proximal femur fracture have high incidences of thrombotic events. By the two "bed-side" methods TEG (Thrombelastography) and MEA (Multiple Electrode Aggregometry), the thrombogenic properties of 220 patients with proximal femur fracture will be measured at time of hospital admission and 4 times over a period of 6 months postoperatively, and the patients will be followed in a total length of 2 years to register thrombotic events.

Study Type

Observational

Enrollment (Anticipated)

33

Contacts and Locations

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

Study Locations

  • Norway
      • Kongsberg, Norway, 3611
        • Kongsberg Hospital, Vestre Viken Hospital Trust

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to our hospital for proximal femur fracture and receive orthopedic surgery with concomittant thrombosis prophylaxis with LMWH or anticoagulation with Warfarin, and are capable to sign/accept informed concent

Description

Inclusion Criteria:

  • Patients older than 18 years who are admitted to our hospital for orthopedic surgery of proximal femur fracture.
  • The study participants must be capable to sign/accept informed concent

Exclusion Criteria:

  • Patients with severe dementia or that of other causes not ar capable to give informed concent.
  • Patients with known or suspected cancer, blood diseases or bleeding disorders
  • Surgery last 6 months
  • Severe renal- (eGFR (creatinine) <30)
  • Severe hepatic failure (2x UNL for bilirubin, 3x UNL for ALAT or INR > 1,3 without anticoagulation treatment)
  • Patients that, by drug spesification or -SPC, not are eligible for postoperative thrombosis prophylaxis

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurements of thrombogenic properties by TEG (Maximum Amplitude) and MEA (Units) and thrombotic events in 220 patients with Hip Fracture.
Time Frame: 24 months
Thrombogenic properties measured by TEG (different measurements as "MA") and MEA (measured as "U") 6 months after operation for hip fracture and clinical thrombotic events over 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurements of thrombogenic properties by TEG (Maximum Amplitude) and MEA (Units) in 220 patients with Hip Fracture.
Time Frame: 6 months
Measurements of thrombogenic properties by TEG and MEA in 220 patients patients with Hip Fracture to investigate any correlation between the two Methods and anti-fXa titer.
6 months
Measurements of thrombogenic properties by TEG (Maximum amplitude) and MEA (Units)) in the 100 patients with Hip Fracture and thrombotic complications
Time Frame: 6 months
Measurements of thrombogenic properties by TEG and MEA (in the first) 100 patients with Hip Fracture and .
6 months

Collaborators and Investigators

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

Sponsor

Vestre Viken Hospital Trust

Investigators

  • Principal Investigator: Øystein Meen, Phd, Kongsberg Hospital, Vestre Viken Hospital Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2015

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

May 31, 2015

First Submitted That Met QC Criteria

June 15, 2015

First Posted (Estimate)

June 18, 2015

Study Record Updates

Last Update Posted (Actual)

April 15, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK 2015/139

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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