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NCT Number: NCT02297061

Can Thrombelastography Predict Blood Loss in Patients With Hip Fractures

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.

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Key information

Conditions

Hip Fracture Blood Loss Femoral Fractures Fractures, Bone Hemorrhage Hip Fractures Hip Injuries Leg Injuries Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Hvidovre University Hospital

Hvidovre, 2650, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thrombelastography analysis (TEG)

Biological

TEG analysis is performed on admission

Primary outcomes

  1. 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.

Secondary outcomes

  1. Thrombotic incidences

    Time frame: 90 days after operation

    Can TEG analysis predict thrombotic incidences in hip fracture patients.

  2. Mortality

    Time frame: 90 days after operation

    Relation between TEG values and mortality.

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Rigshospitalet, Denmark

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 21, 2014
Registry last updated
Nov 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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