Hip FracturePhase 3TRANEXFERNCT02150720
Prevention of Postoperative Bleeding in Subcapital Femoral Fractures
A Phase 3 study testing Tranexamic Acid, Fibrin glue and Electrocauterization in people with Hip Fracture and Blood Loss, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 6 sites in Spain.
Trial summary
The main hypothesis of this clinical trial is that the use of intra-articular tranexamic acid and the fibrin glue plus usual hemostasis will reduce at least a 25% the postoperative blood loss with respect to usual hemostasis in patients undergoing subcapital femoral fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fracture, Blood Loss
- What is being tested?
- Tranexamic Acid, Fibrin glue and Electrocauterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 6 sitesSpain
- Study dates
- Feb 2013to Mar 2016
- 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
- Patients over 18 years
- Patients with unilateral subcapital femoral fracture
- Patients requiring hip replacement (total or partial)
- Signed informed consent from the patient or legal representative
Who cannot join
- Known allergy to fibrin glue and tranexamic acid
- Multiple fractures
- Pathological fractures
- Contraceptives or estrogen therapy
- Use of blood salvage during surgery
- History compatible with thromboembolic disease:
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- Cerebral vascular accident
- Ischemic heart disease (myocardial infarction, angina )
- Deep vein thrombosis
- Pulmonary Embolism
- Peripheral arterial vasculopathy
- Patients with thrombogenic arrhythmias
- Patients with cardiovascular stents
- Prothrombotic alterations in coagulation
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital Germans Trias i Pujol de Badalona
Badalona, Barcelona, 08916
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
Hospital Clinic
Barcelona, Barcelona, 08036
Parc Taulí
Sabadell, Barcelona, 08208
Hospital Universitari Mútua Terrassa
Terrassa, Barcelona, 08221
Hospital Universitari Terrassa-Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08227
About this study
Official title: Prevention of Postoperative Bleeding in Femoral Fractures: a Multicenter, Randomized, Controlled, Parallel Clinical Trial to Assess the Efficacy of Tranexamic Acid and Fibrin Glue
The main hypothesis of this clinical trial is that the use of intra-articular tranexamic acid and the fibrin glue plus usual hemostasis will reduce at least a 25% the postoperative blood loss with respect to usual hemostasis in patients undergoing subcapital femoral fractures.
- Conditions
- Hip Fracture, Blood Loss
- Being tested
- Tranexamic Acid, Fibrin glue, Electrocauterization
- Keywords
- Hip fractures, Clinical Trial, Randomized, Fibrin glue, Tranexamic acid, 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.
Tranexamic AcidDrug
Also called Amchafibrin
1g intra-articular before closing the wound surgery
Fibrin glueDrug
Also called Evicel
5mL intra-articular before closing the wound surgery
ElectrocauterizationProcedure or surgery
Coagulation blood from vessels by means of a electrocautery.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Experimental | Tranexamic acid, 1g intra-articular before closing the surgery wound Receives: Drug: Tranexamic Acid; Procedure: Electrocauterization |
| Fibrin glue | Experimental | One intra-articular dose of fibrin glue (Evicel 5mL) before closing the wound surgery, Receives: Drug: Fibrin glue; Procedure: Electrocauterization |
| Usual hemostasia | Active comparator | Electrocauterization Receives: Procedure: Electrocauterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss (ml) after surgery
The blood lost from the wound will be collected by a drainage system during the first 24 hours postoperatively.
Measured: The first postoperative 24h
Secondary outcomes (10)
Hidden blood loss
The hidden blood loss is the total blood loss calculated by the formula of Nadler minus the blood loss by drain.
Measured: The first postoperative five days
Proportion of patients requiring blood transfusion
Measured: The first postoperative ten days
Units of blood transfused
Measured: The first postoperative ten days
Proportion of patients with wound infection
Measured: The first postoperative month
Proportion of patients with wound dehiscence
Measured: The first postoperative month
Deep venous thrombosis
Measured: The first postoperative ten days
Length of hospital stay
Time from hip surgery until hospital discharge
Measured: The first postoperative ten days
Quality of life measured with the generic EQ-5D -5L
Measured: Preoperatively, at 5 days postoperatively , 1-2, 6 and 12 months postoperative follow-up
Mortality
Measured: During the 12 month of follow-up after surgery
Direct cost
Measured: During the first postoperative month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startFeb 2013
- Primary completionApr 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MJ Martínez-Zapata, MD, PhD, Principal investigator, Iberoamerican Cochrane Centre. Research Institut Hospital de la Santa Creu i Sant Pau. IIB Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150720
- Sponsor's protocol ID
- IIBSP-FAT-2011-103
- Other IDs
- EC11-341, 2011-006278-15, SA/12/AYU/456
- Acronym
- TRANEXFER
- Status last verified
- Sep 2016
- First submitted
- 22 May 2014
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Martínez-Zapata MJ, Jordán M, Aguilera X, Cánovas E, Urrutia G (en nombre del grupo TRANEXFER). Estudio prospectivo multicéntrico de una cohorte para evaluar la calidad de vida de pacientes intervenidos de fractura subcapital de fémur. Trauma 2014; 25 (4): 188-195.
Merchan-Galvis A, Posso M, Canovas E, Jordan M, Aguilera X, Martinez-Zapata MJ. Quality of life and cost-effectiveness analysis of topical tranexamic acid and fibrin glue in femur fracture surgery. BMC Musculoskelet Disord. 2022 Aug 31;23(1):827. doi: 10.1186/s12891-022-05775-y.
PubMed 36045358
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Postoperative Bleeding in Femoral Fractures: a Multicenter, Randomized, Controlled, Parallel Clinical Trial to Assess the Efficacy of Tranexamic Acid and Fibrin Glue
- ClinicalTrials.gov ID
- NCT02150720
- Acronym / sponsor ID
- TRANEXFER / IIBSP-FAT-2011-103
- Conditions
- Hip Fracture, Blood Loss
- Keywords
- Hip fractures, Clinical Trial, Randomized, Fibrin glue, Tranexamic acid, Blood loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 30 May 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.
The main hypothesis of this clinical trial is that the use of intra-articular tranexamic acid and the fibrin glue plus usual hemostasis will reduce at least a 25% the postoperative blood loss with respect to usual hemostasis in patients undergoing subcapital femoral fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Drug: Tranexamic Acid, Procedure: ElectrocauterizationTranexamic acid, 1g intra-articular before closing the surgery wound |
| Fibrin glue | Experimental | Drug: Fibrin glue, Procedure: ElectrocauterizationOne intra-articular dose of fibrin glue (Evicel 5mL) before closing the wound surgery, |
| Usual hemostasia | Active comparator | Procedure: ElectrocauterizationElectrocauterization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over 18 years
- Patients with unilateral subcapital femoral fracture
- Patients requiring hip replacement (total or partial)
- Signed informed consent from the patient or legal representative
Key exclusion criteria (14 listed)
- Known allergy to fibrin glue and tranexamic acid
- Multiple fractures
- Pathological fractures
- Contraceptives or estrogen therapy
- Use of blood salvage during surgery
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: Amchafibrin1g intra-articular before closing the wound surgery | Drug | Tranexamic acid |
| Fibrin glueAlso: Evicel5mL intra-articular before closing the wound surgery | Drug | Fibrin glue |
| ElectrocauterizationCoagulation blood from vessels by means of a electrocautery. | Procedure or surgery | Fibrin glue, Tranexamic acid, Usual hemostasia |
Primary outcome
Blood loss (ml) after surgery
Time frame: The first postoperative 24h
The blood lost from the wound will be collected by a drainage system during the first 24 hours postoperatively.
10 secondary outcomes
Hidden blood loss
Time frame: The first postoperative five days
Proportion of patients requiring blood transfusion
Time frame: The first postoperative ten days
Units of blood transfused
Time frame: The first postoperative ten days
Proportion of patients with wound infection
Time frame: The first postoperative month
Proportion of patients with wound dehiscence
Time frame: The first postoperative month
Deep venous thrombosis
Time frame: The first postoperative ten days
Length of hospital stay
Time frame: The first postoperative ten days
Quality of life measured with the generic EQ-5D -5L
Time frame: Preoperatively, at 5 days postoperatively , 1-2, 6 and 12 months postoperative follow-up
Mortality
Time frame: During the 12 month of follow-up after surgery
Direct cost
Time frame: During the first postoperative month
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 20 Sep 2016.
- Results publicationMartínez-Zapata MJ, Jordán M, Aguilera X, Cánovas E, Urrutia G (en nombre del grupo TRANEXFER). Estudio prospectivo multicéntrico de una cohorte para evaluar la calidad de vida de pacientes intervenidos de fractura subcapital de fémur. Trauma 2014; 25 (4): 188-195.
- Derived from this study: PubMed 36045358Merchan-Galvis A, Posso M, Canovas E, Jordan M, Aguilera X, Martinez-Zapata MJ. Quality of life and cost-effectiveness analysis of topical tranexamic acid and fibrin glue in femur fracture surgery. BMC Musculoskelet Disord. 2022 Aug 31;23(1):827. doi: 10.1186/s12891-022-05775-y.
- Publication of quality of life (subgroup of patients)Link provided by the sponsor.
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Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
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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.
MJ Martínez-Zapata, MD, PhD principal investigator
Iberoamerican Cochrane Centre. Research Institut Hospital de la Santa Creu i Sant Pau. IIB Sant Pau
6 sites 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, Fibrin glue and Electrocauterization in people with Hip Fracture and Blood Loss, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 6 sites in Spain.
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 4 inclusion and 14 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 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. 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.
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?
Blood loss (ml) after surgery (time frame: The first postoperative 24h). 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 NCT02150720, which also lists 2 linked publications.
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 20 Sep 2016.