This is a prospective, randomized, double-blind study investigating whether intravenous tranexamic acid has any effect on blood loss during maxillofacial trauma surgery, or the subsequent postoperative sequelae. Intraoperative bleeding and postoperative ecchymosis and edema are objectively rated and complications are noted.
Full Title of Study: “Effect of Perioperative Tranexamic Acid on Blood Loss During Management of Maxillofacial Trauma: A Randomized Double Blind Clinical Trial”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Study Primary Completion Date: October 15, 2021
This is a prospective, randomized, double-blind pilot study investigating whether intravenous tranexamic acid has any effect on blood loss during maxillofacial trauma surgery, or the subsequent postoperative sequelae. Intraoperative bleeding is calculated from anaesthesia chart and recorded in ml. Postoperative ecchymosis and bleeding are recorded as dichotomous events (yes/no) and are subjectively rated by both patient and surgeon on postoperative days 1and 2. Any surgical or postoperative complications are noted. Scores are aggregated for statistical analysis.
- Drug: Tranexamic acid
- Drug: Tranexamic Acid Injectable Solution the drug will be given to patients intravenously at a dose of 10mg/kg pre-operatively after induction on general anesthesia before incision.
- Drug: Placebo
- Other: Placebo (normal saline 0.9%) An equivalent amount of normal saline (0.9%) will be given to the patient pre-operatively after induction of general anesthesia. The amount of saline given will correspond to the same amount of fluid which would have been given had the patient been in the intervention group.
Arms, Groups and Cohorts
- Experimental: Tranexamic acid
- Experimental: TXA Group One gram of intravenous tranexamic acid (TXA) in normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 6 hours later in the postoperative period.
- Placebo Comparator: Placebo
- Placebo Comparator: Control Group Intravenous normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 6 hours later in the postoperative period.
Clinical Trial Outcome Measures
- Intraoperative blood loss
- Time Frame: Surgical period
- Measured and recorded from the anaesthesia patient chart
- Postoperative bleeding event
- Time Frame: upto 48 hours after surgery
- postoperative bleeding and ecchymosis subjectively reported by patient and assessed by clinician, recorded as a dichotomous outcome.
Participating in This Clinical Trial
- Patients undergoing ORIF under GA for Maxillofacial fractures – Patients between with ages of 16-65 – No cardiac comorbidities (hypertension, congenital heart malformation) – No known coagulopathy – No regular prescription medication altering normal blood coagulation (NSAIDs, other anticoagulants) – ASA I and II patients Exclusion Criteria:
- Patients younger than 16 and older than 65 – Patients with known coagulopathy – Patients with cardiac comorbidities – Patients with a family history of bleeding disorders – ASA III or higher
Gender Eligibility: All
Minimum Age: 16 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- College of Medical Sciences Teaching Hospital. Nepal
- Provider of Information About this Clinical Study
- Principal Investigator: Ashutosh Kumar Singh, Associate professor – College of Medical Sciences Teaching Hospital. Nepal
- Overall Official(s)
- Rajesh Yadav, MD, Study Director, College of Medical Sciences Teaching hospital, Bharatpur, Nepal
- Overall Contact(s)
- Ashutosh K Singh, MDS, +9779855082369, firstname.lastname@example.org
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