Bleeding
Conditions
Keywords
Tranexamic Acid, Periacetabular Osteotomy, Bleeding
Brief summary
In this research study the investigators want to learn more about how a medication called tranexamic acid (TXA) could help reduce bleeding during Periacetabular Osteotomy (PAO) surgery. TXA is approved by the Food and Drug Administration (FDA) for the reduction of bleeding for many types of surgical procedures. TXA works by slowing the breakdown of blood clots and helps to prevent bleeding. From previous studies, TXA has been shown to effectively prevent bleeding in patients undergoing heart, spine and skull remodeling surgeries. As PAO surgery has been associated with significant blood loss when compared to other types of joint surgeries. In order to try and avoid bleeding that may lead to complications, different strategies can be used. In this research study the investigators want to learn more about how a medication called tranexamic acid (TXA) could help reduce bleeding during PAO surgery.
Detailed description
This prospective randomized placebo controlled double blind trial will enroll 80 adolescents and young adults undergoing elective peri-acetabular osteotomy (PAO). The primary aim is to determine if intravenous infusion of TXA during surgery is effective compared to standard care (no TXA) in decreasing blood loss (measured; and calculated) and blood transfusion (autologous and allogenic) perioperatively in adolescents and young adults presenting for PAO surgery. The rate of blood loss over time will be measured and compared between groups with adjustment for length of surgery (time; hours) and body weight (kg).
Interventions
DRUGTranexamic Acid
Intravenous TXA given as a loading dose over 15 minutes of 30 mg/kg bolus (within an hour prior to surgical incision) and 10 mg/kg/hr infusion for the duration of the surgery
DRUGNormal saline
Normal saline infusion
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Patients who choose to participate will be randomized to receive either: 1. placebo i.e. saline 0.9% (intravenous injection) (Control Group) or 2. intravenous TXA given as a loading dose over 15 minutes of 30 mg/kg bolus (within an hour prior to surgical incision) and 10 mg/kg/hr infusion for the duration of the surgery
Eligibility
Sex/Gender
ALL
Age
13 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* ASA 1-2 * Age 13-35 years * Scheduled for primary unilateral PAO +/- arthroscopy
Exclusion criteria
* Hematologic disorder, thrombocytopenia (Platelet count \<140,000/uL3) * Major hepatic, renal, or vascular disorder * Active Thromboembolic disorder * Color vision defect * TXA allergy * Taking anticoagulants or antiplatelet drugs (heparin, warfarin, clopidogrel) * Ethical and/or religious objection to receiving blood products * International patients * Patients undergoing revision surgery * Patients undergoing combined PAO and other surgeries such as surgical dislocation, proximal femoral osteotomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood loss | 1 week after surgery | ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma TXA level | 24 hours | ug/mL |
Countries
United States
Outcome results
None listed