Hip FracturePhase 3THIFNCT00327106
Tranexamic Acid in HIp Fracture Surgery (THIF Study)
A Phase 3 study testing Tranexamic acid (Exacyl) in people with Hip Fracture, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The purpose of this study is to assess the efficacy of tranexamic acid in hip fracture surgery on the reduction of allogeneic red blood cell transfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Tranexamic acid (Exacyl)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2005to Feb 2007
- Phase
- Phase 3
- 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
- Patient requiring surgery for an isolated hip fracture of less than 48 hours
Who cannot join
- Contraindication to tranexamic acid
- Contraindication to fondaparinux
- Contraindication to general anesthesia associated with a femoral nerve block
- pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site
Chu Saint-Etienne
Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055
About this study
Official title: Efficacy of Tranexamic Acid on Perioperative Blood Loss During Hip Fracture Surgery.
The purpose of this study is to assess the efficacy of tranexamic acid in hip fracture surgery on the reduction of allogeneic red blood cell transfusion.
Read the detailed description
Studies in hip and knee arthroplasty (scheduled surgery) have shown that tranexamic acid decreases allogeneic red blood cell transfusion. In hip fracture surgery, an emergent procedure, transfusion is frequent. Transfusion increases adverse events such as postoperative bacterial infection and venous thrombosis. The purpose of this study is to assess the efficacy of tranexamic acid, an anti-fibrinolytic agent, in hip fracture surgery on the reduction of allogeneic red blood cell transfusion. The trial will also evaluate if the reduction in transfusion will be associated with less postoperative infection and without an increase in the thrombotic risk.
Patients with an isolated hip fracture of less than 48 hours will be randomized to either tranexamic acid 15mg/kg IV at skin incision and three hours later or saline.Patients will receive fondaparinux for prophylaxis of venous thrombosis.
- Conditions
- Hip Fracture
- Being tested
- Tranexamic acid (Exacyl), Placebo
- Keywords
- hip fracture, transfusion, tranexamic acid, fondaparinux
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid (Exacyl)Drug
Also called Exacyl
15 mg/kg IV (in the vein), just before surgery and 3 hours after surgery
PlaceboDrug
NaCl 9‰, 0,15 ml/kg IV (in the vein), just before surgery and 3 hours after surgery.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Exacyl Receives: Drug: Tranexamic acid (Exacyl) |
| 2 | Placebo comparator | Physiologic serum Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients receiving the transfusion of at least one unit of allogeneic red blood cell
Measured: between the begining of surgery (day 1) and the eighth post-operative day (day 8)
Secondary outcomes (5)
number of patients receiving the transfusion of at least one unit of allogeneic red blood cell
Measured: between the administration of fondaparinux for venous thrombosis prophylaxis(8 hours after end of surgery on day 1) and the eighth post-operative day (day 8)
post-operative major hemorrhage
Measured: day 8
post-operative blood loss
Measured: untill day 8
post-operative bacterial infection (combined criteria of wound infection, bronchopulmonary infection and urinary tract infection)
Measured: untill six weeks
thromboembolic events (combined criteria of venous thrombo-embolism, stroke, acute coronary syndrome and peripheral arterial thrombosis)
Measured: untill six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2006 (estimated)
- Study startApr 2005
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Investigators
- Paul Zufferey, Doctor, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327106
- Sponsor's protocol ID
- 0401129
- Other IDs
- DGS 2005-01094
- Acronym
- THIF
- Status last verified
- Jun 2009
- First submitted
- 17 May 2006
- Last updated
- 11 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zufferey PJ, Miquet M, Quenet S, Martin P, Adam P, Albaladejo P, Mismetti P, Molliex S; tranexamic acid in hip-fracture surgery (THIF) study. Tranexamic acid in hip fracture surgery: a randomized controlled trial. Br J Anaesth. 2010 Jan;104(1):23-30. doi: 10.1093/bja/aep314.
PubMed 19926634
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tranexamic Acid on Perioperative Blood Loss During Hip Fracture Surgery.
- ClinicalTrials.gov ID
- NCT00327106
- Acronym / sponsor ID
- THIF / 0401129
- Conditions
- Hip Fracture
- Keywords
- hip fracture, transfusion, tranexamic acid, fondaparinux
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 18 May 2006 (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 purpose of this study is to assess the efficacy of tranexamic acid in hip fracture surgery on the reduction of allogeneic red blood cell transfusion.
Detailed description
Studies in hip and knee arthroplasty (scheduled surgery) have shown that tranexamic acid decreases allogeneic red blood cell transfusion. In hip fracture surgery, an emergent procedure, transfusion is frequent. Transfusion increases adverse events such as postoperative bacterial infection and venous thrombosis. The purpose of this study is to assess the efficacy of tranexamic acid, an anti-fibrinolytic agent, in hip fracture surgery on the reduction of allogeneic red blood cell transfusion. The trial will also evaluate if the reduction in transfusion will be associated with less postoperative infection and without an increase in the thrombotic risk.
Patients with an isolated hip fracture of less than 48 hours will be randomized to either tranexamic acid 15mg/kg IV at skin incision and three hours later or saline.Patients will receive fondaparinux for prophylaxis of venous thrombosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Tranexamic acid (Exacyl)Exacyl |
| 2 | Placebo comparator | Drug: PlaceboPhysiologic serum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient requiring surgery for an isolated hip fracture of less than 48 hours
Key exclusion criteria (4 listed)
- Contraindication to tranexamic acid
- Contraindication to fondaparinux
- Contraindication to general anesthesia associated with a femoral nerve block
- pregnancy
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 acid (Exacyl)Also: Exacyl15 mg/kg IV (in the vein), just before surgery and 3 hours after surgery | Drug | 1 |
| PlaceboNaCl 9‰, 0,15 ml/kg IV (in the vein), just before surgery and 3 hours after surgery. | Drug | 2 |
Primary outcome
number of patients receiving the transfusion of at least one unit of allogeneic red blood cell
Time frame: between the begining of surgery (day 1) and the eighth post-operative day (day 8)
5 secondary outcomes
number of patients receiving the transfusion of at least one unit of allogeneic red blood cell
Time frame: between the administration of fondaparinux for venous thrombosis prophylaxis(8 hours after end of surgery on day 1) and the eighth post-operative day (day 8)
post-operative major hemorrhage
Time frame: day 8
post-operative blood loss
Time frame: untill day 8
post-operative bacterial infection (combined criteria of wound infection, bronchopulmonary infection and urinary tract infection)
Time frame: untill six weeks
thromboembolic events (combined criteria of venous thrombo-embolism, stroke, acute coronary syndrome and peripheral arterial thrombosis)
Time frame: untill six weeks
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 11 Jun 2009.
- Derived from this study: PubMed 19926634Zufferey PJ, Miquet M, Quenet S, Martin P, Adam P, Albaladejo P, Mismetti P, Molliex S; tranexamic acid in hip-fracture surgery (THIF) study. Tranexamic acid in hip fracture surgery: a randomized controlled trial. Br J Anaesth. 2010 Jan;104(1):23-30. doi: 10.1093/bja/aep314.
Related trials for Hip Fracture
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
Not yet recruitingObservational study
3D-Printed Pelvic Models for Planning Complex Total Hip Arthroplasty
Developmental Dysplasia of the Hip, Acetabular Bone Loss
Recruiting
Monitored Anesthesia Care and Soft Tissue Infiltration With Local Anesthesia Feasibility Trial
Hip Fracture Surgeries, Intertrochanteric Fracture
Not yet recruitingPhase 4
Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture
Hip Fractures (ICD-10 72.01-72.2), Post Operative Analgesia
Active, not recruitingPhase 2
BDSF Vs DHS With Anterotational Screw in Vertical FNF
Evaluation of BDSF in FNF
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.
Paul Zufferey, Doctor principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic acid (Exacyl) in people with Hip Fracture, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 4 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 11 Jun 2009. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
number of patients receiving the transfusion of at least one unit of allogeneic red blood cell (time frame: between the begining of surgery (day 1) and the eighth post-operative day (day 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00327106, which also lists 1 linked publication.
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 11 Jun 2009.