Lumbar Spinal Stenosis, Thoracic Spinal Stenosis
Conditions
Keywords
lumbar spine surgery, thoracic spine surgery
Brief summary
Hypothesis: Topical application of Tranexamic acid into the surgical wound during spine surgery will decrease the overall blood loss post-operatively. This reduction in blood loss will reduce the need for transfusion. In addition it will also significantly reduce the cost of the surgical procedure. Specific Aim 1: The goal of this study is to quantitatively assess whether topical application of tranexamic acid placed into the surgical wound during lumbar spine surgery will decrease post-operative blood loss, thus lowering the need for blood transfusions. By reducing the number of transfusions participants can avoid the well-known complications associated with them. The investigators do not plan on measuring serum tranexamic acid levels. Several meta-analyses and level I studies have shown that intravenous (IV) administration of tranexamic acid is effective in reducing postoperative blood loss and the need for transfusion.
Detailed description
Tranexamic acid, an antifibrinolytic agent, has been studied at great length across a myriad of medical specialties to reduce blood lost during these surgeries. Topical tranexamic acid administration reduces postoperative blood loss and proved safe in multiple types of surgeries -e.g. cardiothoracic, oral and maxillofacial, eye, ear and throat.(References: Fawzy and others \[et al\], Wong et al, Zufferey et al, Wang et al, Ipema et al). Intravenous tranexamic acid administration has been shown to reduce postoperative blood loss and transfusion need in patients undergoing spinal surgery (Reference: Elwatidy et al). Some advocates have suggested that topical (i.e. local) administration might be preferred over intravenous application. Topical administration of tranexamic acid has some potential advantages as it leads to lower systemic absorption, and offers less concern over the risk of thromboembolic complications (References: Wong et al, Raveendran et al). While systemic (intravenous) use of tranexamic acid has been studied in spine surgery, there has been little studied to show its effectiveness at reducing blood loss when used topically. This study proposes to determine if the topical application of tranexamic acid into the surgical wound of posterior multi-level lumbar spine surgery will decrease postoperative blood loss, thus decreasing the need for potential transfusions. Tranexamic acid has been well documented for its safety and efficacy, the investigators believe that this agent will become an important tool to reduce the blood loss in spinal surgeries. It offers a reduction in blood loss and, ultimately, a decrease in the transfusion rates which pose risks to the subject and significant cost.
Interventions
DRUGTranexamic Acid
A single topical application of 3 grams (g) of Tranexamic acid in 100 milliliter (mL) saline.
DRUGPlacebo
A single topical application of matching placebo, which is 100 mL of normal saline.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 18-85 years, both male and female * Undergoing elective multi-level spinal surgery with a posterior approach to the thoracolumbar spine. * Negative pregnancy test
Exclusion criteria
* Allergy to tranexamic acid * Preoperative anemia (Hemoglobin \<11 grams per deciliter \[g/dL\] ) * Coagulopathy (preoperative platelet count \<150,000, International Normalized Ratio \>1.4, or Partial Thromboplastin Time \> 1.5 times normal) * History of deep vein thrombosis, stroke, or pulmonary embolism * Pregnant or breast feeding * Liver function tests 2 times the upper limit of normal, and those with creatine greater than 1.6 milligrams per deciliter (mg/dL) * Infection * Revision procedure in which the only procedure is removing instrumentation * Renal impairment * Dural tear
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin Level From Preoperative Appointment to Postoperative Hospital Discharge | From preoperative appointment approximately one week before surgery to end of hospital stay up to approximately 5 days after surgery | Blood loss was calculated from the difference between the level of hemoglobin at the preoperative appointment and the lowest level during the postoperative hospitalization period. Reported here is the change in hemoglobin level after surgery. A negative number indicates a reduction in hemoglobin level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Loss Volume Following Surgery | From end of surgery on Day 1 to end of hospital stay up to approximately 5 days | Blood loss following surgery was defined as the total amount of fluid collected from the drain in the wound site during the hospital stay. |
| Hospital Length of Stay in Days | From end of surgery on Day 1 to end of hospital stay up to approximately 2 weeks | The number of days the participants stayed in the hospital after surgery was recorded. |
| Post-operative Blood Transfusions During Hospitalization | From end of surgery on Day 1 to end of hospital stay up to approximately 5 days | All units of blood transfused during the hospital stay after surgery were recorded. One red blood cell unit contains 300 to 360 mL of whole blood. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tranexamic Acid Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated. | 12 |
| Placebo Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated. | 17 |
| Total | 29 |
Baseline characteristics
| Characteristic | Tranexamic Acid | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 69 years | 66 years | 68 years |
| Sex: Female, Male Female | 8 Participants | 12 Participants | 20 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 3 / 12 | 1 / 17 |
Outcome results
Primary
Change in Hemoglobin Level From Preoperative Appointment to Postoperative Hospital Discharge
Blood loss was calculated from the difference between the level of hemoglobin at the preoperative appointment and the lowest level during the postoperative hospitalization period. Reported here is the change in hemoglobin level after surgery. A negative number indicates a reduction in hemoglobin level.
Time frame: From preoperative appointment approximately one week before surgery to end of hospital stay up to approximately 5 days after surgery
Population: Only participants, for whom both preoperative and postoperative time points were collected, are reported in this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tranexamic Acid | Change in Hemoglobin Level From Preoperative Appointment to Postoperative Hospital Discharge | -3.2 grams per deciliter (g/dL) |
| Placebo | Change in Hemoglobin Level From Preoperative Appointment to Postoperative Hospital Discharge | -4.6 grams per deciliter (g/dL) |
p-value: 0.1318Wilcoxon (Mann-Whitney)
Secondary
Blood Loss Volume Following Surgery
Blood loss following surgery was defined as the total amount of fluid collected from the drain in the wound site during the hospital stay.
Time frame: From end of surgery on Day 1 to end of hospital stay up to approximately 5 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tranexamic Acid | Blood Loss Volume Following Surgery | 534 mL |
| Placebo | Blood Loss Volume Following Surgery | 530 mL |
Secondary
Hospital Length of Stay in Days
The number of days the participants stayed in the hospital after surgery was recorded.
Time frame: From end of surgery on Day 1 to end of hospital stay up to approximately 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tranexamic Acid | Hospital Length of Stay in Days | 5 days |
| Placebo | Hospital Length of Stay in Days | 6 days |
Secondary
Post-operative Blood Transfusions During Hospitalization
All units of blood transfused during the hospital stay after surgery were recorded. One red blood cell unit contains 300 to 360 mL of whole blood.
Time frame: From end of surgery on Day 1 to end of hospital stay up to approximately 5 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tranexamic Acid | Post-operative Blood Transfusions During Hospitalization | 0 units of blood |
| Placebo | Post-operative Blood Transfusions During Hospitalization | 0 units of blood |