BridgeMD
New treatment option for Spinal Deformity
Official title Tranexamic Acid in Adult Spinal Deformity Surgery
ClinicalTrials.gov ID: NCT03553186
What this study is testing
What is Tranexamic Acid 100 MG/ML?
Tranexamic Acid 100 MG/ML is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for spinal deformity.
Also referred to as Intervention group.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Posterior spinal surgery for adult deformity is associated with high incidence of blood loss and need for blood transfusion and intraoperative blood salvage, with associated increased cost and risk for perioperative complications. Tranexamic acid (TXA) is relatively inexpensive anti-fibrinolytic agent that has been proven effective for decreasing intraoperative blood loss in various surgical specialties.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age 18-80
- Scheduled to undergo posterior long segment ( ≥ 5 levels) posterior spinal fusion for adult scoliosis or degenerative joint diseae
- \+ fusion to pelvis
You likely can't join if
- Surgical factors:
- Anterior Approach
- Presence or history of dural tear without repair as evidenced by pseudomeningocele on MRI imaging or by intraoperative exploration
- Patients donating autologous blood preoperatively Patient factors:
- Diagnosis of renal (Cr\>1.5 or CrCl \<30ml/min) or hepatic insufficiency (AST, ALT 2x upper limit of normal)
- Diagnosis of seizure disorder or prior seizure
See the full eligibility criteria
- Age 18-80
- Scheduled to undergo posterior long segment ( ≥ 5 levels) posterior spinal fusion for adult scoliosis or degenerative joint diseae
- \+ fusion to pelvis
- Surgical factors:
- Anterior Approach
- Presence or history of dural tear without repair as evidenced by pseudomeningocele on MRI imaging or by intraoperative exploration
- Patients donating autologous blood preoperatively Patient factors:
- Diagnosis of renal (Cr\>1.5 or CrCl \<30ml/min) or hepatic insufficiency (AST, ALT 2x upper limit of normal)
- Diagnosis of seizure disorder or prior seizure
- History of thromboembolic events (CVA, TIA, DVT, PE) if within 1 year of surgery
- Hypercoagulability (e.g. antiphospholipid syndrome)
- History of coronary artery disease (stent, MI, +stress test) within 1 year of surgery
- Atrial fibrillation
- Concurrent anticoagulation therapy that cannot be discontinued within 3 days before surgery (Coumadin, plavix, LVX)
- Concurrent anticoagulation with ASA 325 that cannot be discontinued 10 days before surgery
- Bleeding disorder or abnormal preoperative coagulation profile (as identified by a preoperative platelet count of \ 1.4, or a prolonged partial thromboplastin time \>1.4 times normal)
- Preexisting anemia \<10 g/dL
- Color blindness or disturbance of color vision
- Leukemia or active cancer
- Religious restrictions on blood transfusion
- Pregnancy or women who are lactating/breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.