Trial | NCT04494126  Report issue

Title

Effect of Perioperative Tranexamic Acid on Blood Loss During Management of Maxillofacial Trauma
Effect of Perioperative Tranexamic Acid on Blood Loss During Management of Maxillofacial Trauma: A Randomized Double Blind Clinical Trial

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    200
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.
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.
Study Started
Aug 15
2021
Anticipated
Primary Completion
Oct 15
2021
Anticipated
Study Completion
Dec 15
2021
Anticipated
Last Update
Aug 03
2021

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.

  • Other names: Injection TXA 1 gram

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.

  • Other names: Normal saline

Tranexamic acid Experimental

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 Placebo Comparator

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.

Criteria 

Inclusion Criteria:

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
No Results Posted