NCT02297061

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
Last Updated

November 21, 2014

Status Verified

November 1, 2014

Enrollment Period

5 months

First QC Date

February 9, 2014

Last Update Submit

November 18, 2014

Conditions

Keywords

Hip fractureThrombelastographyBlood loss

Outcome Measures

Primary Outcomes (1)

  • Total blood loss compared to TEG profile on admission

    TEG profiles will be compared to the blood losses of the patients, after completion of the study.

    4 days postoperatively

Secondary Outcomes (2)

  • Thrombotic incidences

    90 days after operation

  • Mortality

    90 days after operation

Study Arms (1)

TEG group

200 consecutive hip fracture patients, Thrombelastography is performed on admission.

Biological: Thrombelastography analysis (TEG)

Interventions

TEG analysis is performed on admission

TEG group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Hip FracturesHemorrhage

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Peter T Tengberg, MD

    Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 9, 2014

First Posted

November 21, 2014

Study Start

December 1, 2013

Primary Completion

May 1, 2014

Study Completion

August 1, 2014

Last Updated

November 21, 2014

Record last verified: 2014-11

Locations