Femoral Shaft FracturePhase 4ORL-ORT-023NCT04803591
This is a Study to Verify if Tranexamic Acid Can Reduce the Anemia After a Femoral Shaft Fractures Surgery
A Phase 4 study testing Tranexamic Acid in people with Femoral Shaft Fracture, run by Christian Candrian.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Femoral Shaft Fracture
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 1 Sep 2026
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
About this study
Official title: Efficacy of Tranexamic Acid in Femoral Shaft Fractures Osteosynthesis; A Double Blind Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Femoral Shaft Fracture
- Being tested
- Tranexamic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called TRANEXAM OrPha Inj Lös 500 mg/5ml
Tranexamic Acid will be administered as an injectable solution (500mg/5ml or 1000mg/10ml).
| Study group | Role | What they receive |
|---|---|---|
| A: Tranexamic Acid group | Experimental | 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). Receives: Drug: Tranexamic Acid |
| B : No treatment group | No intervention | In the control group, will not be administered TXA or any other drugs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative anaemia
Postoperative anaemia detected by daily measurements of haemoglobin in the first 3 days after surgery
Measured: 3 days after surgery
Secondary outcomes (8)
Post-operative anaemia
Post-operative anaemia reported as changes in haemoglobin and haematocrit values during the first 3 days after surgery.
Measured: 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.
Measured: 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
Measured: Up to day 2
Estimated total blood loss.
This outcome will be documented using Hb balance formula.
Measured: Up to day 2
Estimated total blood loss.
This outcome will be documented using Gross Formula.
Measured: 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.
Measured: Up to day 2
Length of hospital stay
Length of hospital stay
Measured: 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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Aug 2021 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Why it stopped: Not approved by Ethics Commettee
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Femoral Shaft FractureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian Candrian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christian Candrian, Ente Ospedaliero Cantonale, Bellinzona
- Investigators
- Christian Candrian, MD; Prof., Principal investigator, EOC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803591
- Sponsor's protocol ID
- ORL - ORT - 023
- Acronym
- ORL-ORT-023
- Status last verified
- Oct 2021
- First submitted
- 10 Mar 2021
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Charoencholvanich K, Siriwattanasakul P. Tranexamic acid reduces blood loss and blood transfusion after TKA: a prospective randomized controlled trial. Clin Orthop Relat Res. 2011 Oct;469(10):2874-80. doi: 10.1007/s11999-011-1874-2. Epub 2011 Apr 22.
PubMed 21512813Haghighi M, Ettehad H, Mardani-Kivi M, Mirbolook A, Nabi BN, Moghaddam R, Sedighinejad A, Khanjanian G. Does Tranexamic Acid Reduce Bleeding during Femoral Fracture Operation? Arch Bone Jt Surg. 2017 Mar;5(2):103-108.
PubMed 28497100Gross JB. Estimating allowable blood loss: corrected for dilution. Anesthesiology. 1983 Mar;58(3):277-80. doi: 10.1097/00000542-198303000-00016. No abstract available.
PubMed 6829965Drakos A, Raoulis V, Karatzios K, Doxariotis N, Kontogeorgakos V, Malizos K, Varitimidis SE. Efficacy of Local Administration of Tranexamic Acid for Blood Salvage in Patients Undergoing Intertrochanteric Fracture Surgery. J Orthop Trauma. 2016 Aug;30(8):409-14. doi: 10.1097/BOT.0000000000000577.
PubMed 26978136Nagra NS, van Popta D, Whiteside S, Holt EM. An analysis of postoperative hemoglobin levels in patients with a fractured neck of femur. Acta Orthop Traumatol Turc. 2016 Oct;50(5):507-513. doi: 10.1016/j.aott.2015.11.001. Epub 2016 Oct 15.
PubMed 27756504Lua J, Tan VH, Sivasubramanian H, Kwek E. Complications of Open Tibial Fracture Management: Risk Factors and Treatment. Malays Orthop J. 2017 Mar;11(1):18-22. doi: 10.5704/MOJ.1703.006.
PubMed 28435569Neumann MV, Strohm PC, Reising K, Zwingmann J, Hammer TO, Suedkamp NP. Complications after surgical management of distal lower leg fractures. Scand J Trauma Resusc Emerg Med. 2016 Dec 9;24(1):146. doi: 10.1186/s13049-016-0333-1.
PubMed 27938394Maniar RN, Kumar G, Singhi T, Nayak RM, Maniar PR. Most effective regimen of tranexamic acid in knee arthroplasty: a prospective randomized controlled study in 240 patients. Clin Orthop Relat Res. 2012 Sep;470(9):2605-12. doi: 10.1007/s11999-012-2310-y. Epub 2012 Mar 15.
PubMed 22419350Jiang W, Shang L. Tranexamic acid can reduce blood loss in patients undergoing intertrochanteric fracture surgery: A meta-analysis. Medicine (Baltimore). 2019 Mar;98(11):e14564. doi: 10.1097/MD.0000000000014564.
PubMed 30882622Xin WQ, Gao YL, Shen J, Yang XY. Intravenous tranexamic acid reduces blood transfusions in revision total hip arthroplasty: a meta-analysis. J Comp Eff Res. 2019 Aug;8(11):917-928. doi: 10.2217/cer-2019-0030. Epub 2019 Aug 22.
PubMed 31436114Yao RZ, Gao WQ, Wang BW, Wang GL, Wu CX, A-Mu YD. Efficacy and Safety of Tranexamic Acid in Reducing Blood Loss of Lower Extremity Osteotomy in Peri-acetabulum and High Tibia: A Systematic Review and Meta-analysis. Orthop Surg. 2019 Aug;11(4):545-551. doi: 10.1111/os.12515.
PubMed 31456323Chen S, Wu K, Kong G, Feng W, Deng Z, Wang H. The efficacy of topical tranexamic acid in total hip arthroplasty: a meta-analysis. BMC Musculoskelet Disord. 2016 Feb 16;17:81. doi: 10.1186/s12891-016-0923-0.
PubMed 26878845Moskal JT, Capps SG. Meta-analysis of Intravenous Tranexamic Acid in Primary Total Hip Arthroplasty. Orthopedics. 2016 Sep 1;39(5):e883-92. doi: 10.3928/01477447-20160526-02. Epub 2016 Jun 1.
PubMed 27248332Barrachina B, Lopez-Picado A, Remon M, Fondarella A, Iriarte I, Bastida R, Rodriguez-Gascon A, Achaerandio MA, Iturricastillo MC, Aizpuru F, Valero CA, Tobalina R, Hernanz R. Tranexamic Acid Compared with Placebo for Reducing Total Blood Loss in Hip Replacement Surgery: A Randomized Clinical Trial. Anesth Analg. 2016 Apr;122(4):986-95. doi: 10.1213/ANE.0000000000001159.
PubMed 26991616Yue C, Kang P, Yang P, Xie J, Pei F. Topical application of tranexamic acid in primary total hip arthroplasty: a randomized double-blind controlled trial. J Arthroplasty. 2014 Dec;29(12):2452-6. doi: 10.1016/j.arth.2014.03.032. Epub 2014 Mar 29.
PubMed 24793893
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tranexamic Acid in Femoral Shaft Fractures Osteosynthesis; A Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04803591
- Acronym / sponsor ID
- ORL-ORT-023 / ORL - ORT - 023
- Conditions
- Femoral Shaft Fracture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not approved by Ethics Commettee
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Christian CandrianUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 17 Mar 2021 (actual)
- 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 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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Tranexamic Acid group | Experimental | Drug: Tranexamic AcidPatients 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). |
| B : No treatment group | No intervention | –In the control group, will not be administered TXA or any other drugs. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
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: TRANEXAM OrPha Inj Lös 500 mg/5mlTranexamic Acid will be administered as an injectable solution (500mg/5ml or 1000mg/10ml). | Drug | A: Tranexamic Acid group |
Primary outcome
Postoperative anaemia
Time frame: 3 days after surgery
Postoperative anaemia detected by daily measurements of haemoglobin in the first 3 days after surgery
8 secondary outcomes
Post-operative anaemia
Time frame: 3 days
Intra-operative blood loss
Time frame: Day 0
Post-operative blood loss at during the first 2 days after surgery
Time frame: Up to day 2
Estimated total blood loss.
Time frame: Up to day 2
Estimated total blood loss.
Time frame: Up to day 2
Blood transfusion requirements.
Time frame: Up to day 2
Length of hospital stay
Time frame: Up to week 2
Cost effectiveness of the treatment with tranexamic acid.
Time frame: 1 week
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 13 Oct 2021.
- Background: PubMed 21512813Charoencholvanich K, Siriwattanasakul P. Tranexamic acid reduces blood loss and blood transfusion after TKA: a prospective randomized controlled trial. Clin Orthop Relat Res. 2011 Oct;469(10):2874-80. doi: 10.1007/s11999-011-1874-2. Epub 2011 Apr 22.
- Background: PubMed 28497100Haghighi M, Ettehad H, Mardani-Kivi M, Mirbolook A, Nabi BN, Moghaddam R, Sedighinejad A, Khanjanian G. Does Tranexamic Acid Reduce Bleeding during Femoral Fracture Operation? Arch Bone Jt Surg. 2017 Mar;5(2):103-108.
- Background: PubMed 6829965Gross JB. Estimating allowable blood loss: corrected for dilution. Anesthesiology. 1983 Mar;58(3):277-80. doi: 10.1097/00000542-198303000-00016. No abstract available.
- Background: PubMed 26978136Drakos A, Raoulis V, Karatzios K, Doxariotis N, Kontogeorgakos V, Malizos K, Varitimidis SE. Efficacy of Local Administration of Tranexamic Acid for Blood Salvage in Patients Undergoing Intertrochanteric Fracture Surgery. J Orthop Trauma. 2016 Aug;30(8):409-14. doi: 10.1097/BOT.0000000000000577.
- Background: PubMed 27756504Nagra NS, van Popta D, Whiteside S, Holt EM. An analysis of postoperative hemoglobin levels in patients with a fractured neck of femur. Acta Orthop Traumatol Turc. 2016 Oct;50(5):507-513. doi: 10.1016/j.aott.2015.11.001. Epub 2016 Oct 15.
- Background: PubMed 28435569Lua J, Tan VH, Sivasubramanian H, Kwek E. Complications of Open Tibial Fracture Management: Risk Factors and Treatment. Malays Orthop J. 2017 Mar;11(1):18-22. doi: 10.5704/MOJ.1703.006.
- Background: PubMed 27938394Neumann MV, Strohm PC, Reising K, Zwingmann J, Hammer TO, Suedkamp NP. Complications after surgical management of distal lower leg fractures. Scand J Trauma Resusc Emerg Med. 2016 Dec 9;24(1):146. doi: 10.1186/s13049-016-0333-1.
- Background: PubMed 22419350Maniar RN, Kumar G, Singhi T, Nayak RM, Maniar PR. Most effective regimen of tranexamic acid in knee arthroplasty: a prospective randomized controlled study in 240 patients. Clin Orthop Relat Res. 2012 Sep;470(9):2605-12. doi: 10.1007/s11999-012-2310-y. Epub 2012 Mar 15.
- Background: PubMed 30882622Jiang W, Shang L. Tranexamic acid can reduce blood loss in patients undergoing intertrochanteric fracture surgery: A meta-analysis. Medicine (Baltimore). 2019 Mar;98(11):e14564. doi: 10.1097/MD.0000000000014564.
- Background: PubMed 31436114Xin WQ, Gao YL, Shen J, Yang XY. Intravenous tranexamic acid reduces blood transfusions in revision total hip arthroplasty: a meta-analysis. J Comp Eff Res. 2019 Aug;8(11):917-928. doi: 10.2217/cer-2019-0030. Epub 2019 Aug 22.
- Background: PubMed 31456323Yao RZ, Gao WQ, Wang BW, Wang GL, Wu CX, A-Mu YD. Efficacy and Safety of Tranexamic Acid in Reducing Blood Loss of Lower Extremity Osteotomy in Peri-acetabulum and High Tibia: A Systematic Review and Meta-analysis. Orthop Surg. 2019 Aug;11(4):545-551. doi: 10.1111/os.12515.
- Background: PubMed 26878845Chen S, Wu K, Kong G, Feng W, Deng Z, Wang H. The efficacy of topical tranexamic acid in total hip arthroplasty: a meta-analysis. BMC Musculoskelet Disord. 2016 Feb 16;17:81. doi: 10.1186/s12891-016-0923-0.
- helsinki-ethical-principles-for-medical-research-involving-human-subjectsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Christian Candrian, MD; Prof. principal investigator
EOC
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid in people with Femoral Shaft Fracture, run by Christian Candrian.
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 6 inclusion and 13 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 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Postoperative anaemia (time frame: 3 days after surgery). 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 NCT04803591, which also lists 23 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 13 Oct 2021; AzTrials last refreshed its copy on 30 Oct 2026.