Tranexamic Acid to Reduce Blood Loss in Spine Trauma Surgery
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Orthopedic, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 3/30/2019 |
| Start Date: | October 2019 |
| End Date: | July 2021 |
| Contact: | Ronald A Lehman, MD |
| Email: | rl2781@cumc.columbia.edu |
| Phone: | 2129325067 |
Topical Application of Tranexamic Acid to Reduce Blood Loss During Complex Combat-related Spine Trauma Surgery
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. Patients following high
energy trauma who have sustained thoracic or lumbar spine fractures, dislocations or
ligamentous injury with resultant instability requiring posterior spinal fusion will be
enrolled for this study. Furthermore, patients undergoing elective complex deformity surgery
will also be enrolled. Both populations of patients will be randomized into two groups. Group
I will receive standard of care operative fixation with topical tranexamic acid intervention
(test); Group II will receive standard of care operative fixation with normal saline
(placebo) intervention. This study will have a 2-year follow-up and will consist of three
periods: screening/enrollment phase up to 21 days from the day of injury to the day of
randomization and operative intervention, an inpatient data collection period for 4 days
postoperative, and then a follow-up period for 2-years postoperative (visits occurring at 2
week, 16 week, 1 year, and 2 year) time points.
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. Patients following high
energy trauma who have sustained thoracic or lumbar spine fractures, dislocations or
ligamentous injury with resultant instability requiring posterior spinal fusion will be
enrolled for this study. Furthermore, patients undergoing elective complex deformity surgery
will also be enrolled. Both populations of patients will be randomized into two groups. Group
I will receive standard of care operative fixation with topical tranexamic acid intervention
(test); Group II will receive standard of care operative fixation with normal saline
(placebo) intervention. This study will have a 2-year follow-up and will consist of three
periods: screening/enrollment phase up to 21 days from the day of injury to the day of
randomization and operative intervention, an inpatient data collection period for 4 days
postoperative, and then a follow-up period for 2-years postoperative (visits occurring at 2
week, 16 week, 1 year, and 2 year) time points.
Reducing perioperative blood loss is critically important in the treatment of multiply
injured combat casualties, and major blood loss during complex spine trauma surgery is a
significant concern. Similar to previous studies in dental, cardiac, and total knee
arthroplasty procedures, the use of topical tranexamic acid during complex combat related
spine trauma surgery can be a cost-effective and simple route of administration to reduce
blood loss, with no significant systemic effects. Patients would be expected to benefit
immediately by decreasing blood loss and the need for blood transfusion postoperatively,
thereby exposing them to less risk of transfusion reactions or disease transmission. This may
also potentially decrease the rate of surgical site infection because patients have been
found to have a significantly increased risk for surgical site infection after blood
transfusion due to changes in the immune system, and by also decreasing the amount of blood
that collects under the surgical wound, which serves as excellent medium for bacterial
growth. The goal of the investigators study is to determine if the use of topical tranexamic
acid (TXA) in the setting of complex spine trauma surgery reduces blood loss, and
subsequently reduces the rate of allogenic blood transfusion and surgical site infection.
injured combat casualties, and major blood loss during complex spine trauma surgery is a
significant concern. Similar to previous studies in dental, cardiac, and total knee
arthroplasty procedures, the use of topical tranexamic acid during complex combat related
spine trauma surgery can be a cost-effective and simple route of administration to reduce
blood loss, with no significant systemic effects. Patients would be expected to benefit
immediately by decreasing blood loss and the need for blood transfusion postoperatively,
thereby exposing them to less risk of transfusion reactions or disease transmission. This may
also potentially decrease the rate of surgical site infection because patients have been
found to have a significantly increased risk for surgical site infection after blood
transfusion due to changes in the immune system, and by also decreasing the amount of blood
that collects under the surgical wound, which serves as excellent medium for bacterial
growth. The goal of the investigators study is to determine if the use of topical tranexamic
acid (TXA) in the setting of complex spine trauma surgery reduces blood loss, and
subsequently reduces the rate of allogenic blood transfusion and surgical site infection.
Inclusion Criteria:
1. Thoracic or lumbar spinal column injury with or without neurologic deficit requiring
surgical fixation
2. Surgical fixation to be performed within 21 days of injury
3. Adult patients undergoing long segment (>5 fusion levels) posterior spinal fusions
Exclusion Criteria:
1. Age <18 or >75 years old
2. Severe soft tissue disruption around planned surgical site preventing adequate primary
wound closure
3. Physiologic instability or ongoing sepsis/infection
4. Use of intravenous tranexamic acid during the pre-study period
5. Ballistic spinal column injury
6. Allergy to tranexamic acid
7. Disturbances of color vision or color blindness
8. 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
9. Refusal to consent for blood products
10. Participation in another clinical trial
11. Previous thoracic or lumbar spine surgery
12. Moderate or severe traumatic brain injuries that do not allow participation in
individual patient outcomes surveys
13. Subarachnoid hemorrhage, anecdotal experience indicates that cerebral edema and
cerebral infarction may be caused by TXA
14. Concomitant use of Factor IX Complex concentrates or Anti-inhibitor Coagulant
concentrates, as the risk of thrombosis may be increased
15. 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 before surgery
16. Fibrinolytic disorders requiring intraoperative antifibrinolytic treatment
17. Disseminated intravascular coagulation (DIC)
18. Coagulopathy (as identified by a preoperative platelet count of <150,000/mm3, an
international normalized ratio of >1.4, or a prolonged partial thromboplastin time
>1.4 times normal)
19. 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
20. Upper urinary tract or ureteral injury (ureteral obstruction due to clot formation in
patients with upper urinary tract bleeding has been reported)
21. Pregnancy or breastfeeding (Category B)
22. Substantial renal dysfunction (as assessed by a serum creatinine > 1.5 or calculated
creatinine clearance of < 50) or hepatic failure
23. 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 IV], previous myocardial
infarction, severe pulmonary disease [forced expiratory volume <50% of normal],
diabetes mellitus (Type I or Type II), immunosuppression, peripheral vascular disease,
severe penetrating or hemorrhagic traumatic brain injury, a history of skeletal
malignancies, prior external beam or implant radiation therapy involving the skeleton.
24. History of seizure or convulsive disorders, or currently concomitant use of other
medications that are known to reduce seizure threshold
25. History of dural tear or open subdural space
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