Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04803591
Status:
WITHDRAWN
Last Update Posted:
2021-10-13
First Post:
2021-03-10
Brief Title:
This is a Study to Verify if Tranexamic Acid Can Reduce the Anemia After a Femoral Shaft Fractures Surgery
Sponsor:
Christian Candrian
Organization:
Ente Ospedaliero Cantonale Bellinzona
Study Overview
Official Title:
Efficacy of Tranexamic Acid in Femoral Shaft Fractures Osteosynthesis A Double Blind Randomized Controlled Trial
Status:
WITHDRAWN
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not approved by Ethics Commettee
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORL-ORT-023
Brief 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
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 100000 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 1500 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 IV 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
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 IV 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None