Femoral Shaft Fracture Clinical Trial
— ORL-ORT-023Official title:
Efficacy of Tranexamic Acid in Femoral Shaft Fractures Osteosynthesis; A Double Blind Randomized Controlled Trial
Verified date | October 2021 |
Source | Ente Ospedaliero Cantonale, Bellinzona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 1, 2026 |
Est. primary completion date | September 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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)>1.4Ă— 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Christian Candrian |
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative anaemia | Postoperative anaemia detected by daily measurements of haemoglobin in the first 3 days after surgery | 3 days after surgery | |
Secondary | Post-operative anaemia | Post-operative anaemia reported as changes in haemoglobin and haematocrit values during the first 3 days after surgery. | 3 days | |
Secondary | 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. | Day 0 | |
Secondary | 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 | Up to day 2 | |
Secondary | Estimated total blood loss. | This outcome will be documented using Hb balance formula. | Up to day 2 | |
Secondary | Estimated total blood loss. | This outcome will be documented using Gross Formula. | Up to day 2 | |
Secondary | 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. | Up to day 2 | |
Secondary | Length of hospital stay | Length of hospital stay | Up to week 2 | |
Secondary | 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. | 1 week |
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