Blood Loss
Conditions
Keywords
Maxillofacial trauma; blood loss
Brief summary
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.
Detailed description
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.
Interventions
DRUGTranexamic 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.
DRUGPlacebo
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.
Sponsors
College of Medical Sciences Teaching Hospital. Nepal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Only the anaesthesiologist who is administering the medications is unmasked until completion of the data collection period.
Intervention model description
Randomized, double-blind, Parallel assignment
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative blood loss | Surgical period | Measured and recorded from the anaesthesia patient chart |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative bleeding event | upto 48 hours after surgery | postoperative bleeding and ecchymosis subjectively reported by patient and assessed by clinician, recorded as a dichotomous outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Complications if any during surgery and upto 48 hours after surgery | upto 48 hours after surgery | complications related to surgery as reported by patient and clinician |
Contacts
Primary ContactAshutosh K Singh, MDS
Backup ContactAshutosh K Singh, MDS
Outcome results
None listed