Hip FractureNCT02297061
Can Thrombelastography Predict Blood Loss in Patients With Hip Fractures
An observational study of Hip Fracture and Blood Loss, run by Hvidovre University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Fracture, Blood Loss
- What is being tested?
- Thrombelastography analysis (TEG)
- How many people
- 180 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2013to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hip fracture patients admitted to Hvidovre University Hospital in the study period.
Who may be able to join
- All hip fracture patients admitted through the emergency room (ER) at Hvidovre University Hospital in the study period.
Who cannot join
- Hip fracture patients who are transfered from other wards in the hospital do not go through the ER and are not included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hip Fracture, Blood Loss
- Being tested
- Thrombelastography analysis (TEG)
- Keywords
- Hip fracture, Thrombelastography, Blood loss
- Medical subject headings
- Hip Fractures, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombelastography analysis (TEG)Biological
TEG analysis is performed on admission
| Study group | Role | What they receive |
|---|---|---|
| TEG group | 200 consecutive hip fracture patients, Thrombelastography is performed on admission. Receives: Biological: Thrombelastography analysis (TEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 days postoperatively
Secondary outcomes (2)
Thrombotic incidences
Can TEG analysis predict thrombotic incidences in hip fracture patients.
Measured: 90 days after operation
Mortality
Relation between TEG values and mortality.
Measured: 90 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startDec 2013
- Primary completionMay 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Peter Toft Tengberg, Hvidovre University Hospital
- Investigators
- Peter T Tengberg, MD, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297061
- Sponsor's protocol ID
- TEGHIP
- Status last verified
- Nov 2014
- First submitted
- 9 Feb 2014
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Value of Thrombelastogralhy to Pre-operatively Predict Hip Fracture Patients at Risk of Major Blood Loss During and After Surgery.
- ClinicalTrials.gov ID
- NCT02297061
- Acronym / sponsor ID
- TEGHIP
- Conditions
- Hip Fracture, Blood Loss
- Keywords
- Hip fracture, Thrombelastography, Blood loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- Dec 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEG group | – | Biological: Thrombelastography analysis (TEG)200 consecutive hip fracture patients, Thrombelastography is performed on admission. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hip fracture patients admitted to Hvidovre University Hospital in the study period.
Key inclusion criteria (1 listed)
- All hip fracture patients admitted through the emergency room (ER) at Hvidovre University Hospital in the study period.
Key exclusion criteria (1 listed)
- Hip fracture patients who are transfered from other wards in the hospital do not go through the ER and are not included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thrombelastography analysis (TEG)TEG analysis is performed on admission | Biological | TEG group |
Primary outcome
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.
2 secondary outcomes
Thrombotic incidences
Time frame: 90 days after operation
Mortality
Time frame: 90 days after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter T Tengberg, MD principal investigator
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fracture and Blood Loss, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total blood loss compared to TEG profile on admission (time frame: 4 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2014.