A Phase 4 interventional study of Tranexamic Acid in Femoral Shaft Fracture, sponsored by Christian Candrian. Withdrawn. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-10-13.
Sponsored by Christian Candrian · Phase 4, Interventional, and Treatment
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The investigators are going to evaluate if adding Tranexamic Acid in femoral shaft fractures surgery can lead to any advantages to the participants, namely if it can reduce post-operative anaemia, blood loss, blood transfusion requirements, length and cost of hospitalisation.
Lower limb procedures represent the majority of orthopaedic surgeries, including joint arthroplasties, sport medicine treatments, and fractures osteo-synthesis, with a rate over 500 per 100,000 population every year, increasing. Albeit being successful procedures routinely performed in the clinical practice, they are frequently encumbered by complications. In particular, femur fractures are common and frequently result in considerable blood loss, ranging from 900 to 1,500 ml, which exposes patients to postoperative anaemia and reduced functional recovery. Allogenic blood transfusions are financial burden, and, even more, they are associated with an unneglectable risk of serious complications, including infection, immuno-suppression, cardiovascular dysfunction, resulting in potentially life-threatening effects on patients. Various strategies have been attempted to minimize blood loss and the need for blood transfusion, and to this aim the use of hemostatic agents, in particular of tranexamic acid (TXA), has recently widely increased in orthopaedic lower limb surgery.
TXA is a synthetic anti-fibrinolytic agent that competitively blocks the lysine binding sites on plasminogen, thereby slowing the conversion of plasminogen to plasmin, thus preventing fibrin clot degradation. A large amount of randomized controlled trials and meta-analysis converge in showing that TXA, applied either through systemic or local administration, is effective in reducing blood loss and subsequent transfusions in lower limb fractures surgery, especially in hip fracture patients, as well in replacement procedures. However, there are still concerns about the risk of increasing venous thromboembolic (VTE) complications, such as deep venous thrombosis or pulmonary embolisms; overall, the scientific high-level literature evidence supports the safety of TXA for the different orthopaedic applications.
This is a 2-arm study aimed at comparing the Tranexamic Acid supplementation protocol and evaluating his advantages over routine protocols. The primary objective will be the effect on postoperative anaemia, detected by serial measurements of haemoglobin, of TXA supplementation for femoral shaft fractures surgery. The secondary objectives of the study will be the comparison between I.V. peri-operative TXA supplementation and normal protocol without TXA in terms of post-operative anaemia (detected by serial haematocrit measurements), intra-operative blood loss, post-operative blood loss, total blood loss (evaluated using the Hb balance formula, estimated blood loss, blood transfusion requirements, length of hospitalisation, cost-effectiveness and frequency of adverse events. In particular the study aims to assess safety of TXA and its tolerability in terms of incidence of venous thromboembolic complications, such as deep venous thrombosis or pulmonary embolisms, wound infection, and death. The safety of TXA supplementation protocol will be verified comparing to the no-treatment group in terms of incidence of complications, such as deep venous thrombosis (based on the Homan sign and Mose sign and confirmed by compression ultrasonography upon clinical suspicion), Pulmonary embolism (confirmed by spiral computed tomography), cerebrovascular accident (confirmed by computed tomographic scan or magnetic resonance imaging), and acute coronary syndrome or myocardial infarction (confirmed by troponin I estimation and electrocardiogram changes), infection, and death. This randomized control trial will thus define if the peri-operative protocol should be implemented with tranexamic acid to reduce post-operative anaemia and blood loss and the rate of blood transfusion leading to a better cost effectiveness, without an increase in adverse events.
The study presents only minimal risks for the included patients.
Christian Candrian is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in the Tranexamic Acid (TXA) group (arm-A) will be administered with 2 doses of intravenous tranexamic acid (cumulative dose 10ml=1g) as follows: the first dose 10 minutes before the surgical incision (1 vial of 5 ml = 0,5g by slow intravenous injection(=1ml/minute)), and the second 3 hours after the start of surgery (1 vial of 5 ml = 0,5g, by slow intravenous injection).
Drug: Tranexamic Acid
In the control group, will not be administered TXA or any other drugs.
Tranexamic Acid will be administered as an injectable solution (500mg/5ml or 1000mg/10ml).
Also known as: TRANEXAM OrPha Inj Lös 500 mg/5ml
Postoperative anaemia
Postoperative anaemia detected by daily measurements of haemoglobin in the first 3 days after surgery
Time frame: 3 days after surgery
Post-operative anaemia
Post-operative anaemia reported as changes in haemoglobin and haematocrit values during the first 3 days after surgery.
Time frame: 3 days
Intra-operative blood loss
This outcome will be documented using a suction apparatus during the procedure. Blood collected in the suction bottle will be measured by subtracting the volume of saline used for wash.
Time frame: Day 0
Post-operative blood loss at during the first 2 days after surgery
This outcome will be documented using postoperative drain outputs. Blood collected in the drain outputs will be measured in milliliter at 24h and 48h
Time frame: Up to day 2
Estimated total blood loss.
This outcome will be documented using Hb balance formula.
Time frame: Up to day 2
Estimated total blood loss.
This outcome will be documented using Gross Formula.
Time frame: Up to day 2
Blood transfusion requirements.
This outcome will be documented in terms of number of patients who required packed red blood cell (PRBC) (transfusion rate) and the mean number of transfusion units per patient during all the length of hospitalization.
Time frame: Up to day 2
Length of hospital stay
Length of hospital stay
Time frame: Up to week 2
Cost effectiveness of the treatment with tranexamic acid.
This outcome will be documented reporting the mean cost per patient as sum of the cost TXA administration (if administered), the transfusion cost per patients, and the cost of hospital stay.
Time frame: 1 week
No study locations are listed for this record.
Plan to share: No
Start is estimated for Aug 2021; primary completion for Sep 2026, 61 months later.
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This study is withdrawn, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tranexamic Acid
Christian Candrian