Can Thrombelastography Predict Blood Loss in Patients With Hip Fractures

November 18, 2014 updated by: Peter Toft Tengberg, Hvidovre University Hospital

Study on the Value of Thrombelastogralhy to Pre-operatively Predict Hip Fracture Patients at Risk of Major Blood Loss During and After Surgery.

Hip fractures are associated with a large hidden blood loss. That is, the total blood loss associated with hip fracture surgery is much greater than that observed intra operatively. There is currently no viable method of identifying patients at risk of transfusion. The on admission haemoglobin level has been shown to be falsely reassuring .

We are conducting a study of 200 consecutive hip fracture patients. Thrombelastography (TEG) is taken on admission. The results are blinded to clinicians. Results will be evaluated at the end of the study, comparing intra-operative and total blood losses with the TEG profile of the patient.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hip fractures are associated with a large hidden blood loss. That is, the total blood loss associated with hip fracture surgery is much greater than that observed intra operatively. The total blood loss depends on the type of fracture and associated surgery. Extra-capsular fractures treated with an intramedullary nail are thus associated with the largest hidden blood loss with a median of approximately 1500 ml . This hidden blood loss is primarily associated with the trauma and fracture itself and not, as such, with the surgical procedure.

Postoperative anaemia necessitating transfusion and a haemoglobin level below 8 g per dL, in hip fracture patients, are both associated with an increased mortality Controversy remains on the benefits and indications for transfusion in this group of patients.

There is currently no viable method of identifying patients at risk of transfusion. The on admission haemoglobin level has been shown to be falsely reassuring . TEG has to our knowledge only been used in one previous study of hip fractures. The outcome measure in this study was thromboembolic events. We have not been able to identify any studies on the use of TEG, INR, APTT or other tests as predictors of blood loss in hip fracture patients.

Clinicians would greatly benefit from a tool to predict the at-risk patient on admission. TEG has been suggested as such a tool. Bolliger et al suggests that TEG can be used in goal-oriented algorithms to optimize targeted transfusion therapies in trauma patients or patients undergoing major surgery. We hypothesize that TEG can be used for this purpose in patients with hip fracture. These patients can have large blood losses and they sustain the double trauma of a hip fracture and major orthopaedic surgery.

Study Type

Observational

Enrollment (Actual)

180

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

  • Denmark
      • Hvidovre, Denmark, 2650
        • Hvidovre University Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Hip fracture patients admitted to Hvidovre University Hospital in the study period.

Description

Inclusion Criteria:

  • All hip fracture patients admitted through the emergency room (ER) at Hvidovre University Hospital in the study period.

Exclusion Criteria:

  • Hip fracture patients who are transfered from other wards in the hospital do not go through the ER and are not included.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TEG group
200 consecutive hip fracture patients, Thrombelastography is performed on admission.
Biological: Thrombelastography analysis (TEG)
TEG analysis is performed on admission

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total blood loss compared to TEG profile on admission
Time Frame: 4 days postoperatively
TEG profiles will be compared to the blood losses of the patients, after completion of the study.
4 days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thrombotic incidences
Time Frame: 90 days after operation
Can TEG analysis predict thrombotic incidences in hip fracture patients.
90 days after operation
Mortality
Time Frame: 90 days after operation
Relation between TEG values and mortality.
90 days after operation

Collaborators and Investigators

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

Sponsor

Hvidovre University Hospital

Collaborators

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Peter T Tengberg, MD, Hvidovre University Hospital

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

December 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

February 9, 2014

First Submitted That Met QC Criteria

November 18, 2014

First Posted (Estimate)

November 21, 2014

Study Record Updates

Last Update Posted (Estimate)

November 21, 2014

Last Update Submitted That Met QC Criteria

November 18, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEGHIP

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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