Blood Loss During Surgery, Duration of Surgery, Hemoglobin Level Measurement
Conditions
Keywords
Tranexamic acid, Oral and maxillofacial trauma surgery, Blood loss, Hemoglobin, Duration of surgery
Brief summary
Tranexamic acid (TXA) is an inexpensive, easily used and relatively safe drug. It inhibits plasminogen activation and plasmin thus retards clot disintegration.Therapeutic application of tranexamic acid in trauma for preventing blood loss has been documented since long. Since blood loss causes several serious complications, it is compensated emergently by transfusion of blood or its products. However, transfusion of blood and products always carries a risk of inadvertent transmission of infection, antigen-antibody reactions and additional cost all of which can be prevented if blood loss is reduced. Morbidity associated with the delay in compensating the blood loss could also be prevented by pharmaceutically preventing hemorrhage.
Detailed description
During management of maxillofacial injuries, hemostasis is essential to clear the airway also. It is reported that blood loss is the most common complication following maxillofacial fractures and their treatment.TXA oral rinse has been used for preventing excessive hemorrhage for patients with coagulopathies. IV TXA has also been proven to be effective in reducing bleeding in healthy adults undergoing third molar surgery. Administration of TXA has also been evaluated and found effective in reducing post-surgical hemorrhage during and after bimaxillary orthognathic surgery. This study has been planned to evaluate how efficacious is preoperative tranexamic acid in decreasing blood loss while performing surgery in cases with maxillofacial trauma in our local setting. the study results will provide local evidence and will support the incorporation of safe and inexpensive drug i.e., TXA into trauma clinical practice guidelines and local treatment protocols.
Interventions
DRUGTranexamic Acid (TXA)
Thirty minutes prior to surgery, the intervention group receive intravenous , single dose of tranexamic acid of 20 mg/kg.
DRUGNormal saline
Thirty minutes prior to surgery, the placebo group received single dose of 20 mL of normal saline.
Sponsors
Nishtar Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* either gender. * presenting within seven days of trauma. * planned for maxillofacial surgery.
Exclusion criteria
* Patients with international normalized ratio (INR) greater than 1.5. * American Society of Anesthesiologists (ASA) physical status of 3 or higher. * chronic kidney disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mean intraoperative blood loss | Immediately at the end of surgery | mean intraoperative blood loss between patients receiving intravenous tranexamic acid and those receiving placebo during maxillofacial trauma surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mean drop in hemoglobin levels postoperatively | 03 hours after post operatively | To assess the mean drop in hemoglobin levels postoperatively between the TXA and placebo groups. |
| intraoperative blood transfusion | Preoperative | To evaluate the need for intraoperative blood transfusion between the two groups. |
Countries
Pakistan
Contacts
STUDY_DIRECTORDr. Saima Munir, FCPS (OMFS)
Nishtar institute of dentistry, Multan
Outcome results
None listed