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New treatment option for Spinal Injuries
Official title Tranexamic Acid to Reduce Blood Loss in Spine Surgery
ClinicalTrials.gov ID: NCT02314988
What this study is testing
What is Tranexamic Acid?
Tranexamic Acid is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for spinal injuries.
Also referred to as Cyclokapron, TXA.
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
- This study is designed to evaluate the efficacy of topical tranexamic acid to reduce perioperative blood loss, reduction in postoperative drain output and allogenic transfusion requirements. The proposed study will be a prospective, randomized, double-blind (subject, surgeons, investigators, research coordinators) placebo-controlled study.
- 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
- Thoracic or lumbar spinal column injury with or without neurologic deficit requiring surgical fixation
- Surgical fixation to be performed within 21 days of injury
- Adult patients undergoing long segment (\>5 fusion levels) posterior spinal fusions
You likely can't join if
- Age \ 80 years old
- Severe soft tissue disruption around planned surgical site preventing adequate primary wound closure
- Physiologic instability or ongoing sepsis/infection
- Use of intravenous tranexamic acid during the pre-study period
- Ballistic spinal column injury
- Allergy to tranexamic acid
See the full eligibility criteria
- Thoracic or lumbar spinal column injury with or without neurologic deficit requiring surgical fixation
- Surgical fixation to be performed within 21 days of injury
- Adult patients undergoing long segment (\>5 fusion levels) posterior spinal fusions
- Age \ 80 years old
- Severe soft tissue disruption around planned surgical site preventing adequate primary wound closure
- Physiologic instability or ongoing sepsis/infection
- Use of intravenous tranexamic acid during the pre-study period
- Ballistic spinal column injury
- Allergy to tranexamic acid
- Disturbances of color vision or color blindness
- Pre-operative hemoglobin value of \<7 g/dL, or \<10 g/dL if patient has comorbidities or symptoms which will require pre-operative allogeneic blood transfusion
- Refusal to consent for blood products
- Participation in another clinical trial
- Moderate or severe traumatic brain injuries that do not allow participation in individual patient outcomes surveys
- Subarachnoid hemorrhage, anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by TXA
- Concomitant use of Factor IX Complex concentrates or Anti-inhibitor Coagulant concentrates, as the risk of thrombosis may be increased
- Preoperative use of anticoagulant therapy (heparin, low-molecular weight heparin, warfarin) within three days before surgery, or non-steroid inflammatory medication (aspirin, ibuprofen, naprosyn) use within seven days...
- Fibrinolytic disorders requiring intraoperative antifibrinolytic treatment
- Disseminated intravascular coagulation (DIC)
- Coagulopathy (as identified by a preoperative platelet count of \ 1.4, or a prolonged partial thromboplastin time \>1.4 times normal)
- History of arterial or venous thromboembolic disease (such as a cerebrovascular accident, deep-vein thrombosis, or pulmonary embolus), as these patients may be at increased risk for venous or arterial thrombosis
- Upper urinary tract or ureteral injury (ureteral obstruction due to clot formation in patients with upper urinary tract bleeding has been reported)
- Pregnancy or breastfeeding (Category B)
- Substantial renal dysfunction (as assessed by a serum creatinine \> 1.5 or calculated creatinine clearance of \< 50) or hepatic failure
- Major co-morbidities: alcohol or drug abuse, illnesses that affect bone or calcium metabolism, connective tissue disorders, coronary artery disease, severe ischemic heart disease [New York Heart Association Class III or...
- History of seizure or convulsive disorders, or currently concomitant use of other medications that are known to reduce seizure threshold
- History of dural tear or open subdural space
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Louisville, Kentucky, United States
- New York, New York, United States
- Durham, North Carolina, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 San Francisco, California, United States; Louisville, Kentucky, United States; New York, New York, United States; Durham, North Carolina, 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.