The Effectiveness Of Intravenous TXA on Reducing Perioperative Blood Loss For Patients Undergoing PAO
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 13 - 35 |
| Updated: | 2/1/2019 |
| Start Date: | February 2019 |
| End Date: | February 28, 2021 |
| Contact: | Sirirat Rattanaarpa, MD |
| Email: | sirirat.rattanaarpa@childrens.harvard.edu |
| Phone: | 8572184585 |
The Effectiveness Of Intravenous Tranexamic Acid (TXA) on Reducing Perioperative Blood Loss For Patients Undergoing Periacetabular Osteotomy (PAO): A Randomized Double Blind Placebo Controlled Trial
In this research study we 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 we want to learn more about how a
medication called tranexamic acid (TXA) could help reduce bleeding during PAO surgery.
(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 we want to learn more about how a
medication called tranexamic acid (TXA) could help reduce bleeding during PAO surgery.
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).
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).
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
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