Hip FractureNCT01535781
Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced?
A study testing Tranexamic Acid in people with Hip Fracture and Anemia, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The effect of Tranexamic acid on blood loss, hemoglobin and transfusions in patients with pertrochanteric hip fractures. Tranexamic acid is a well known drug used in many types of surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fracture, Anemia
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2011to Aug 2014
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients planned to undergo osteosynthesis with short intramedullary nail for a pertrochanteric hip fracture.
- ASA score 3, 2 or 1
Who cannot join
- Allergy for tranexamic acid
- Clinical signs of acute thromboembolic event
- Renal function impairment (S-creatinin>120micromol/l)
- Active thrombotic disease or DIC
- K-vitamin antagonist treatment
- Malignancy
Show all 9Show fewer
- Pathological fracture
- Previously operated in same hip
- BW > 100kg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Tranexamic Acid on Blood Loss and Transfusion Need in Patients Operated With a Short Intramedullary Nail, for Pertrochanteric Fractures .
The effect of Tranexamic acid on blood loss, hemoglobin and transfusions in patients with pertrochanteric hip fractures.
Tranexamic acid is a well known drug used in many types of surgery. The investigators wish to investigate if the use of tranexamic acid can reduce the peri- and post-operative blood loss in patients who undergo surgery with a short intramedullary nail, for a pertrochanteric hip fracture.
An interim analysis was planned when reaching 60 inclusions. The interim analysis was conducted only on the primary outcome (TBL). A difference in TBL of no less than 500 ml was considered a reason to halt the study. The 0.001 level was chosen as a simple approach to this interim analysis from the Haybittle-Peto boundary
Read the detailed description
Studies have shown that hip fractures have a hidden blood loss besides the recorded perioperative blood loss. Patients who are osteosynthesised with an intramedullary nail have been shown to have the largest hidden blood loss.
Postoperative anaemia is associated with a higher morbidity and mortality. We wish to investigate the possibility of reducing this hidden blood loss, with the use of a well known drug (tranexamic acid) that is widely used to reduce blood loss in other forms of surgery and in multitraumatized patients.
- Conditions
- Hip Fracture, Anemia
- Being tested
- Tranexamic Acid, Placebo
- Keywords
- pertrochanteric fracture, tranexamic acid, postoperative blood loss, blood loss, hidden blood loss, blood transfusions
- Medical subject headings
- Hip Fractures, Anemia, Postoperative Hemorrhage, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called Cyklokapron (tranexamic acid)
1 g of tranexamic acid as a bolus immediately before surgery 3 g of tranexamic acid in 24hours postop.
PlaceboDrug
Also called Saline
Identical syringe and drip used as in the intervention, to ensure blinding.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients are given saline instead of tranexamic acid in the placebo group Receives: Drug: Placebo |
| Tranexamic Acid | Active comparator | Tranexamic acid; 1 gram as a bolus prior to surgery. 3 grams of Tranexamic acid in 1 liter of saline as a 24 hour infusion. Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Blood Loss
Calculated as described by Foss et al in their study of 2006. "Hidden Blood Loss After Surgery for Hip Fracture" JBJS br. 2006.
Measured: time in hospital (approximately 10 days)
Secondary outcomes (3)
Transfusions
Information from local blood bank
Measured: From admission to third day after surgery.
Mortality
Mortality is obtained via central personal registration system (Danish CPR system)
Measured: 30 days and 90 days follow up
Thromboembolic Event (clinical, NOT by routine ultrasound measurement)
Obtained in-hospital, through routine check ups daily. After discharge; obtained from patient records.
Measured: 90 days follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2012 (estimated)
- Study startSep 2011
- Primary completionJun 2014
- Study completionAug 2014
Why it stopped: Recruiting slower than expected.
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Toft Tengberg, Hvidovre University Hospital
- Investigators
- Peter T Tengberg, MD, Principal investigator, Hvidovre University HospitalHenrik Palm, MD, Study chair, Hvidovre University HospitalAnders Troelsen, PhD, Study director, Hvidovre University HospitalMichael Krasheninnikoff, MD, Study chair, Hvidovre University HospitalNicolai B Foss, PhD, Dr.Med, Study chair, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535781
- Sponsor's protocol ID
- TA0001
- Status last verified
- Feb 2015
- First submitted
- 23 Nov 2011
- Last updated
- 5 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tranexamic Acid on Blood Loss and Transfusion Need in Patients Operated With a Short Intramedullary Nail, for Pertrochanteric Fractures .
- ClinicalTrials.gov ID
- NCT01535781
- Acronym / sponsor ID
- TA0001
- Conditions
- Hip Fracture, Anemia
- Keywords
- pertrochanteric fracture, tranexamic acid, postoperative blood loss, blood loss, hidden blood loss, blood transfusions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruiting slower than expected.
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 20 Feb 2012 (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.
The effect of Tranexamic acid on blood loss, hemoglobin and transfusions in patients with pertrochanteric hip fractures.
Tranexamic acid is a well known drug used in many types of surgery. The investigators wish to investigate if the use of tranexamic acid can reduce the peri- and post-operative blood loss in patients who undergo surgery with a short intramedullary nail, for a pertrochanteric hip fracture.
An interim analysis was planned when reaching 60 inclusions. The interim analysis was conducted only on the primary outcome (TBL). A difference in TBL of no less than 500 ml was considered a reason to halt the study. The 0.001 level was chosen as a simple approach to this interim analysis from the Haybittle-Peto boundary
Detailed description
Studies have shown that hip fractures have a hidden blood loss besides the recorded perioperative blood loss. Patients who are osteosynthesised with an intramedullary nail have been shown to have the largest hidden blood loss.
Postoperative anaemia is associated with a higher morbidity and mortality. We wish to investigate the possibility of reducing this hidden blood loss, with the use of a well known drug (tranexamic acid) that is widely used to reduce blood loss in other forms of surgery and in multitraumatized patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPatients are given saline instead of tranexamic acid in the placebo group |
| Tranexamic Acid | Active comparator | Drug: Tranexamic AcidTranexamic acid; 1 gram as a bolus prior to surgery. 3 grams of Tranexamic acid in 1 liter of saline as a 24 hour infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients planned to undergo osteosynthesis with short intramedullary nail for a pertrochanteric hip fracture.
- ASA score 3, 2 or 1
Key exclusion criteria (9 listed)
- Allergy for tranexamic acid
- Clinical signs of acute thromboembolic event
- Renal function impairment (S-creatinin>120micromol/l)
- Active thrombotic disease or DIC
- K-vitamin antagonist treatment
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 |
|---|---|---|
| Tranexamic AcidAlso: Cyklokapron (tranexamic acid)1 g of tranexamic acid as a bolus immediately before surgery 3 g of tranexamic acid in 24hours postop. | Drug | Tranexamic Acid |
| PlaceboAlso: SalineIdentical syringe and drip used as in the intervention, to ensure blinding. | Drug | Placebo |
Primary outcome
Total Blood Loss
Time frame: time in hospital (approximately 10 days)
Calculated as described by Foss et al in their study of 2006. "Hidden Blood Loss After Surgery for Hip Fracture" JBJS br. 2006.
3 secondary outcomes
Transfusions
Time frame: From admission to third day after surgery.
Mortality
Time frame: 30 days and 90 days follow up
Thromboembolic Event (clinical, NOT by routine ultrasound measurement)
Time frame: 90 days follow up
Results and safety
The study was stopped early (reason given: Recruiting slower than expected.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2015.
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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
Henrik Palm, MD study chair
Hvidovre University Hospital
Anders Troelsen, PhD study director
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic Acid in people with Hip Fracture and Anemia, 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 2 inclusion and 9 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: stopped early, as of the sponsor's last update on 5 Feb 2015. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Recruiting slower than expected.). Results are not available in the source record.
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 (time frame: time in hospital (approximately 10 days)). 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 5 Feb 2015.