This is a Study to Verify if Tranexamic Acid Can Reduce the Anemia After a Femoral Shaft Fractures Surgery (ORL-ORT-023)
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| ClinicalTrials.gov Identifier: NCT04803591 |
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Recruitment Status :
Withdrawn
(Not approved by Ethics Commettee)
First Posted : March 17, 2021
Last Update Posted : October 13, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Femoral Shaft Fracture | Drug: Tranexamic Acid | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Efficacy of Tranexamic Acid in Femoral Shaft Fractures Osteosynthesis; A Double Blind Randomized Controlled Trial |
| Estimated Study Start Date : | August 1, 2021 |
| Estimated Primary Completion Date : | September 1, 2026 |
| Estimated Study Completion Date : | September 1, 2026 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: A: Tranexamic Acid group
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).
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Drug: Tranexamic Acid
Tranexamic Acid will be administered as an injectable solution (500mg/5ml or 1000mg/10ml).
Other Name: TRANEXAM OrPha Inj Lös 500 mg/5ml |
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No Intervention: B : No treatment group
In the control group, will not be administered TXA or any other drugs.
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- Postoperative anaemia [ Time Frame: 3 days after surgery ]Postoperative anaemia detected by daily measurements of haemoglobin in the first 3 days after surgery
- Post-operative anaemia [ Time Frame: 3 days ]Post-operative anaemia reported as changes in haemoglobin and haematocrit values during the first 3 days after surgery.
- Intra-operative blood loss [ Time Frame: Day 0 ]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.
- Post-operative blood loss at during the first 2 days after surgery [ Time Frame: Up to day 2 ]This outcome will be documented using postoperative drain outputs. Blood collected in the drain outputs will be measured in milliliter at 24h and 48h
- Estimated total blood loss. [ Time Frame: Up to day 2 ]This outcome will be documented using Hb balance formula.
- Estimated total blood loss. [ Time Frame: Up to day 2 ]This outcome will be documented using Gross Formula.
- Blood transfusion requirements. [ Time Frame: Up to day 2 ]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.
- Length of hospital stay [ Time Frame: Up to week 2 ]Length of hospital stay
- Cost effectiveness of the treatment with tranexamic acid. [ Time Frame: 1 week ]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.
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Acute femoral shaft fracture.
- Patients treated surgically with intramedullary nail or femoral plate
- Patients aged 18-80 years old.
- Patients with a BMI >18.5 and <35.
- Patients able to provide informed consent and follow all the study procedures as indicated by the protocol.
- Informed Consent as documented by signature
Exclusion Criteria:
- Pathological fracture or other lower limb fractures associated or multiple fractures.
- Use of any anticoagulant at the time of admission (eg, vitamin K antagonists, anti-thrombin agents, antiplatelet agents or factor IIa and Xa inhibitors).
- Contraindications to TXA (eg documented allergy to TXA).
- Hepatic dysfunction (aspartate transaminase (AST)/alanine transaminase (ALT)>60 U/l) or renal dysfunction (Cr >1.5 mg/dl of glomerular filtration rate (GFR)>30 ml/min).
- History of DVT or pulmonary embolus.
- Active coronary artery disease or cerebrovascular accident (event in the past 12 months).
- Coagulopathy based on admission laboratory values (international normalised ratio (INR)>1.4, partial thromboplastin time (PTT)>1.4× normal sec, platelets <50 000 per mm3)
- Women who are pregnant or breast feeding.
- Known or suspected non-compliance, drug or alcohol abuse.
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
- Participation in another study with investigational drug within the 30 days preceding and during the present study.
- Previous enrolment into the current study.
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04803591
| Principal Investigator: | Christian Candrian, MD; Prof. | EOC |
Publications:
| Responsible Party: | Christian Candrian, Principal Investigator, Ente Ospedaliero Cantonale, Bellinzona |
| ClinicalTrials.gov Identifier: | NCT04803591 |
| Other Study ID Numbers: |
ORL - ORT - 023 |
| First Posted: | March 17, 2021 Key Record Dates |
| Last Update Posted: | October 13, 2021 |
| Last Verified: | October 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Fractures, Bone Femoral Fractures Wounds and Injuries Leg Injuries Tranexamic Acid |
Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |