Femur SurgeryPhase 4NCT02164565
The Use of Tranexamic Acid (TXA) Intravenously, to Reduce Blood Loss in Proximal Femur Surgery
A Phase 4 study testing Tranexamic Acid (TXA) treatment in people with Femur Surgery, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
The use of Tranexamic Acid (TXA) intravenously, to Reduce Blood Loss in proximal femur surgery. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Femur Surgery
- What is being tested?
- Tranexamic Acid (TXA) treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2014to Mar 2015
- Phase
- Phase 4
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 60, who came to the orthopedic department for proximal femur fracture surgery
- Sound judgment
Who cannot join
- Known hypersensitivity to Tranexamic Acid or component solution provided
- Subarachnoid hemorrhage
- Acquired color blindness
- Myocardial infarction in 12 months before admission
- Unstable angina
- Known clotting disorders (Thromboembolic disease in the past, elongated PT and PTT, hypercoagulability),
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- Kidney or liver failure
- Another situation prostate resection , pathologic fractures according to anamnesis or by imaging
- Oncology patients
- Patients on anticoagulation
- Patients undergoing vascular intervention ( coronary or peripheral ), which was inserted Supporter requires a Dual antiplatelet therapy
Trial locations and contacts
1 site in 1 country.
About this study
The use of Tranexamic Acid (TXA) intravenously, to Reduce Blood Loss in proximal femur surgery.
- Conditions
- Femur Surgery
- Being tested
- Tranexamic Acid (TXA) treatment, control grup: without Tranexamic Acid (TXA) treatment.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid (TXA) treatmentDrug
Tranexamic Acid (TXA) treatment
control grup: without Tranexamic Acid (TXA) treatment.Drug
control grup: without Tranexamic Acid (TXA) treatment.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid (TXA) treatment | Experimental | Tranexamic Acid (TXA) treatment Receives: Drug: Tranexamic Acid (TXA) treatment |
| control grup: without Tranexamic Acid (TXA) treatment. | Experimental | control grup: without Tranexamic Acid (TXA) treatment. Receives: Drug: control grup: without Tranexamic Acid (TXA) treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of blood loss in ml.
Hbloss=BV X (Hbi - Hbe) X 0.001 + Hbt Hbi - hemoglobin level before the surgery ) gram X liter-1(. Hbe - hemoglobin level 3 days after the surgery ( gram X liter-1). Hbt - The amount of hemoglobin that was given in the blood transfusion (gram). Hbloss - Change of hemoglobin loss.
After calculating the amount of loss of hemoglobin, the volume of blood lost can be found:
Blood loss = 1000 X Hbloss/ Hbi
Evaluation of blood loss will be through:
- Comparing hemoglobin level before and after surgery and calculation of quantitative Change of hemoglobin loss.
2 .Registration evaluating blood loss at the end of surgery 3. Collecting and recording blood drain. 4. Tracking Blood Transfusion. Of course we collect the data: assessment of bleeding in the analysis, the number of blood units given, the amount of blood collected drain
Measured: up to 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2015
- Study completionMar 2015
Why it stopped: Enrollment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femur SurgeryStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nimrod Rozen, Prof., Principal investigator, Division of Orthopedic & Rehabilitatio, HaEmek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164565
- Sponsor's protocol ID
- 104-12-EMC
- Status last verified
- Aug 2017
- First submitted
- 29 May 2014
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Tranexamic Acid (TXA) Intravenously, to Reduce Blood Loss in Proximal Femur Surgery
- ClinicalTrials.gov ID
- NCT02164565
- Acronym / sponsor ID
- 104-12-EMC
- Conditions
- Femur Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Enrollment difficulties
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 16 Jun 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 use of Tranexamic Acid (TXA) intravenously, to Reduce Blood Loss in proximal femur surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid (TXA) treatment | Experimental | Drug: Tranexamic Acid (TXA) treatmentTranexamic Acid (TXA) treatment |
| control grup: without Tranexamic Acid (TXA) treatment. | Experimental | Drug: control grup: without Tranexamic Acid (TXA) treatment.control grup: without Tranexamic Acid (TXA) treatment. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 60, who came to the orthopedic department for proximal femur fracture surgery
- Sound judgment
Key exclusion criteria (11 listed)
- Known hypersensitivity to Tranexamic Acid or component solution provided
- Subarachnoid hemorrhage
- Acquired color blindness
- Myocardial infarction in 12 months before admission
- Unstable angina
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 (TXA) treatmentTranexamic Acid (TXA) treatment | Drug | Tranexamic Acid (TXA) treatment |
| control grup: without Tranexamic Acid (TXA) treatment.control grup: without Tranexamic Acid (TXA) treatment. | Drug | control grup: without Tranexamic Acid (TXA) treatment. |
Primary outcome
Evaluation of blood loss in ml.
Time frame: up to 13 months
Hbloss=BV X (Hbi - Hbe) X 0.001 + Hbt Hbi - hemoglobin level before the surgery ) gram X liter-1(. Hbe - hemoglobin level 3 days after the surgery ( gram X liter-1). Hbt - The amount of hemoglobin that was given in the blood transfusion (gram). Hbloss - Change of hemoglobin loss. After calculating the amount of loss of hemoglobin, the volume of blood lost can be found: Blood loss = 1000 X Hbloss/ Hbi Evaluation of blood loss will be through: 1. Comparing hemoglobin level before and after surgery and calculation of quantitative Change of hemoglobin loss. 2 .Registration evaluating blood loss at the end of surgery 3. Collecting and recording blood drain. 4. Tracking Blood Transfusion. Of course we collect the data: assessment of bleeding in the analysis, the number of blood units given, the amount of blood collected drain
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
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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.
Nimrod Rozen, Prof. principal investigator
Division of Orthopedic & Rehabilitatio, HaEmek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid (TXA) treatment in people with Femur Surgery, run by HaEmek Medical Center, Israel 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 11 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: withdrawn, as of the sponsor's last update on 16 Aug 2017. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Evaluation of blood loss in ml. (time frame: up to 13 months). 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 16 Aug 2017.