Closed Fracture of HipNCT01326403
Tranexamic Acid in Hip Fracture Patients
A study testing Tranexamic acid in people with Closed Fracture of Hip, run by Michal Roll PhD,MBA at 1 site in Israel.
Trial summary
This is a randomized controlled trial comparing the use of tranexamic acid to placebo in patients admitted to hospital with a hip fracture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Closed Fracture of Hip
- 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
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2012to Jun 2013
- 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 admitted to the emergency room with proximal hip fractures (31A-31B according to the Muller AO classification of fractures - long bones).
- Patients mentally capable of giving informed consent.
Who cannot join
- Vascular events within the last 2 months such as CVA, TIA, ACS, MI, DVT or arterial thrombosis.
- Patients receiving anticoagulation therapy with Coumadin or Plavix.
- Pregnancy and breastfeeding females.
- Previous arterial or venous thrombosis
- History of seizures.
- Creatinine >2.
- Oestroprogestive therapy.
- Multiple fractures.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sourasky Medical Center
Tel Aviv
ELI STEINBERG, MD, 0524266346, STEINBERGE@TASMC.HEALTH.GOV.IL
AMIR SHLAIFER, MD, 0527360803, SHLAIFER.MD@GMAIL.COM
About this study
This is a randomized controlled trial comparing the use of tranexamic acid to placebo in patients admitted to hospital with a hip fracture.
Read the detailed description
- transfusion of allogeneic RBC's is not free of adverse events and has been associated with an increased risk of postoperative infection
- Tranexamic acid in trauma patients has been shown to reduce 30-day mortality. Hospital trauma protocol includes tranexamic acid in patients with major bleeding.
- Tranexamic acid in orthopedic elective joint reconstruction surgery has been shown to substantially decrease bleeding in knee and hip arthroplasty.
- in hip fracture surgery, transexamic acid reduces erythrocyte transfusion rate but may promote a hypercoagulable state.
- Tranexamic acid is an antifibrinolytic drug that inhibits plasminogen from turning into plasmin thereby inhibiting clot breakdown.
- Conditions
- Closed Fracture of Hip
- Being tested
- Tranexamic acid
- Keywords
- proximal, hip, fractures
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called placebo group, post injury group, preoperative group
GROUP A - receive IV Tranexamic acid 1 gram upon diagnosis and consent in the emergency room. A second 1 gram in a slow drip during the next 8 hours.
GROUP B - IV Tranexamic acid 1 gram five minutes before skin incision and a second 1 gram in a slow drip during the next 8 hours.
Group C - A control group will only receive placebo in the emergency room and in the OR.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients will receive IV Tranexamic acid 1 gram upon diagnosis and consent in the emergency room. A second 1 gram in a slow drip during the next 8 hours. Receives: Drug: Tranexamic acid |
| GROUP B | Experimental | Patients will receive IV Tranexamic acid 1 gram five minutes before skin incision and a second 1 gram in a slow drip during the next 8 hours. Receives: Drug: Tranexamic acid |
| GROUP C | Placebo comparator | A control group will only receive placebo in the emergency room and in the OR. Receives: Drug: Tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of blood loss per patient from admission to day 5 post-op
Measured: 5 DAYS
Secondary outcomes (5)
Number of packed cell transfusion per patient.
Measured: 5 DAYS
Initial functional outcome and feeling of well-being.
Measured: 5 days
thromboembolic events
Measured: 5 days
post-operative bacterial infection
Measured: 5 days
30 day mortality rate
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startJun 2012
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Closed Fracture of HipStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michal Roll PhD,MBA
- Sponsor type
- Other government
- Collaborators
- Tel-Aviv Sourasky Medical Center
- Responsible party
- Sponsor-investigator, Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center
- Investigators
- ELI SHTEINBERG, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326403
- Sponsor's protocol ID
- TASMC-11-ES-0129-CTIL
- Status last verified
- Jun 2012
- First submitted
- 21 Mar 2011
- Last updated
- 7 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid in Hip Fracture Patients
- ClinicalTrials.gov ID
- NCT01326403
- Acronym / sponsor ID
- TASMC-11-ES-0129-CTIL
- Conditions
- Closed Fracture of Hip
- Keywords
- proximal, hip, fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Michal Roll PhD,MBAOther government
- Collaborators
- Tel-Aviv Sourasky Medical Center
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 30 Mar 2011 (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.
This is a randomized controlled trial comparing the use of tranexamic acid to placebo in patients admitted to hospital with a hip fracture.
Detailed description
- transfusion of allogeneic RBC's is not free of adverse events and has been associated with an increased risk of postoperative infection
- Tranexamic acid in trauma patients has been shown to reduce 30-day mortality. Hospital trauma protocol includes tranexamic acid in patients with major bleeding.
- Tranexamic acid in orthopedic elective joint reconstruction surgery has been shown to substantially decrease bleeding in knee and hip arthroplasty.
- in hip fracture surgery, transexamic acid reduces erythrocyte transfusion rate but may promote a hypercoagulable state.
- Tranexamic acid is an antifibrinolytic drug that inhibits plasminogen from turning into plasmin thereby inhibiting clot breakdown.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Tranexamic acidPatients will receive IV Tranexamic acid 1 gram upon diagnosis and consent in the emergency room. A second 1 gram in a slow drip during the next 8 hours. |
| GROUP B | Experimental | Drug: Tranexamic acidPatients will receive IV Tranexamic acid 1 gram five minutes before skin incision and a second 1 gram in a slow drip during the next 8 hours. |
| GROUP C | Placebo comparator | Drug: Tranexamic acidA control group will only receive placebo in the emergency room and in the OR. |
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 admitted to the emergency room with proximal hip fractures (31A-31B according to the Muller AO classification of fractures - long bones).
- Patients mentally capable of giving informed consent.
Key exclusion criteria (8 listed)
- Vascular events within the last 2 months such as CVA, TIA, ACS, MI, DVT or arterial thrombosis.
- Patients receiving anticoagulation therapy with Coumadin or Plavix.
- Pregnancy and breastfeeding females.
- Previous arterial or venous thrombosis
- History of seizures.
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: placebo group, post injury group, preoperative groupGROUP A - receive IV Tranexamic acid 1 gram upon diagnosis and consent in the emergency room. A second 1 gram in a slow drip during the next 8 hours. GROUP B - IV Tranexamic acid 1 gram five minutes before skin incision and a second 1 gram in a slow drip during the next 8 hours. Group C - A control group will only receive placebo in the emergency room and in the OR. | Drug | GROUP B, GROUP C, Group A |
Primary outcome
Total amount of blood loss per patient from admission to day 5 post-op
Time frame: 5 DAYS
5 secondary outcomes
Number of packed cell transfusion per patient.
Time frame: 5 DAYS
Initial functional outcome and feeling of well-being.
Time frame: 5 days
thromboembolic events
Time frame: 5 days
post-operative bacterial infection
Time frame: 5 days
30 day mortality rate
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2012.
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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.
ELI SHTEINBERG, MD principal investigator
Tel-Aviv Sourasky Medical Center
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 Closed Fracture of Hip, run by Michal Roll PhD,MBA at 1 site in Israel.
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 8 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: status not confirmed, as of the sponsor's last update on 7 Jun 2012. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amount of blood loss per patient from admission to day 5 post-op (time frame: 5 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 7 Jun 2012.