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The purpose of this study is to determine if tranexamic acid reduces perioperative blood loss and red blood cell transfusion during high risk spine surgery.
There are conflicting studies in the literature reporting different efficacy outcomes for the use of antifibrinolytics in spine fusion surgery. Several studies support the successful use of tranexamic acid for major orthopedic procedures, but the patient populations studied for spine surgery thus far have been small and highly variable, with less than clinically significant results. If TXA if efficacious in reducing not only perioperative blood loss, but RBC transfusion without an increase in thromboembolic events, then its use may be justified for patients at risk for major blood transfusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid | Experimental | Tranexamic acid 10mg/kg loading dose given pre-incision and 1mg/kg/hr infusion throughout intraoperative period |
|
| Placebo | Placebo Comparator | Normal saline placebo loading dose 0.5ml/kg and infusion at 0.5ml/kg/hr throughout operative course |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | intravenous administration of bolus and infusion for duration of surgical procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Red Blood Cells Transfused in the Intraoperative Period | Total red blood cells transfused in the intraoperative period in (mL). Total RBC equal packed red blood cells and cell saver infusion. | Intraoperative period (approximately 12 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Additional Blood Products Transfused | Total additional blood products (fresh frozen plasma, cryoprecipitate, and platelets) transfused in the perioperative period measured in units. | 24 hours after skin incision |
| Post Operative Major Morbidity |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Intraoperative Blood Loss | Estimated Intraoperative blood loss in milliliters (mLs) | Incision to skin closure (approximately 10 hours) |
| Total Tranexamic Acid Dose (mg) | Total milligrams of intravenous tranexamic acid administered during the surgical procedure. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louanne M Carabini, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20407351 | Background | Elgafy H, Bransford RJ, McGuire RA, Dettori JR, Fischer D. Blood loss in major spine surgery: are there effective measures to decrease massive hemorrhage in major spine fusion surgery? Spine (Phila Pa 1976). 2010 Apr 20;35(9 Suppl):S47-56. doi: 10.1097/BRS.0b013e3181d833f6. | |
| 16850951 | Background | Yang BP, Ondra SL, Chen LA, Jung HS, Koski TR, Salehi SA. Clinical and radiographic outcomes of thoracic and lumbar pedicle subtraction osteotomy for fixed sagittal imbalance. J Neurosurg Spine. 2006 Jul;5(1):9-17. doi: 10.3171/spi.2006.5.1.9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tranexamic Acid | Tranexamic acid 10mg/kg loading dose given pre-incision and 1mg/kg/hr infusion throughout intraoperative period Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure |
| FG001 | Placebo | Normal saline placebo loading dose 0.5ml/kg and infusion at 0.5ml/kg/hr throughout operative course Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tranexamic Acid | Tranexamic acid 10mg/kg loading dose given pre-incision and 1mg/kg/hr infusion throughout intraoperative period Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Red Blood Cells Transfused in the Intraoperative Period | Total red blood cells transfused in the intraoperative period in (mL). Total RBC equal packed red blood cells and cell saver infusion. | Posted | Median | Inter-Quartile Range | milliliters | Intraoperative period (approximately 12 hours) |
|
Start of surgery to discharge from the hospital ( approximately 7 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tranexamic Acid | Tranexamic acid 10mg/kg loading dose given pre-incision and 1mg/kg/hr infusion throughout intraoperative period Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Composite outcome of postoperative adverse events | General disorders | Systematic Assessment | The events cannot be separated. Data was reported as composite outcome of postoperative morbidity including arterial or venous thromboembolic , renal or neurologic morbitity. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Luanne Carabini MD | Northwestern University | 312-695-0061 | l-carabini@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 6, 2015 | Nov 26, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Number of participants who experienced arterial or venous thromboembolism, neurologic complications (including stroke, seizure,and delirium), infections, and pulmonary renal or cardiac adverse outcomes (demand ischemia, myocardial infarction or new arrhythmia) before another operative procedure or hospital discharge.
| Time of surgery to date of discharge from hospital (average 7 days) |
| Intraoperative period |
| 19476865 | Background | Bernard AC, Davenport DL, Chang PK, Vaughan TB, Zwischenberger JB. Intraoperative transfusion of 1 U to 2 U packed red blood cells is associated with increased 30-day mortality, surgical-site infection, pneumonia, and sepsis in general surgery patients. J Am Coll Surg. 2009 May;208(5):931-7, 937.e1-2; discussion 938-9. doi: 10.1016/j.jamcollsurg.2008.11.019. Epub 2009 Mar 26. |
| 22250113 | Background | Ferraris VA, Davenport DL, Saha SP, Austin PC, Zwischenberger JB. Surgical outcomes and transfusion of minimal amounts of blood in the operating room. Arch Surg. 2012 Jan;147(1):49-55. doi: 10.1001/archsurg.2011.790. |
| 19050037 | Background | Henry D, Carless P, Fergusson D, Laupacis A. The safety of aprotinin and lysine-derived antifibrinolytic drugs in cardiac surgery: a meta-analysis. CMAJ. 2009 Jan 20;180(2):183-93. doi: 10.1503/cmaj.081109. Epub 2008 Dec 2. |
| 17943760 | Background | Henry DA, Carless PA, Moxey AJ, O'Connell D, Stokes BJ, McClelland B, Laupacis A, Fergusson D. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD001886. doi: 10.1002/14651858.CD001886.pub2. |
| 19007970 | Background | Kagoma YK, Crowther MA, Douketis J, Bhandari M, Eikelboom J, Lim W. Use of antifibrinolytic therapy to reduce transfusion in patients undergoing orthopedic surgery: a systematic review of randomized trials. Thromb Res. 2009 Mar;123(5):687-96. doi: 10.1016/j.thromres.2008.09.015. Epub 2008 Nov 12. |
| 20554319 | Background | CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14. |
| 19011538 | Background | Elwatidy S, Jamjoom Z, Elgamal E, Zakaria A, Turkistani A, El-Dawlatly A. Efficacy and safety of prophylactic large dose of tranexamic acid in spine surgery: a prospective, randomized, double-blind, placebo-controlled study. Spine (Phila Pa 1976). 2008 Nov 15;33(24):2577-80. doi: 10.1097/BRS.0b013e318188b9c5. |
| 22047046 | Background | Endres S, Heinz M, Wilke A. Efficacy of tranexamic acid in reducing blood loss in posterior lumbar spine surgery for degenerative spinal stenosis with instability: a retrospective case control study. BMC Surg. 2011 Nov 3;11:29. doi: 10.1186/1471-2482-11-29. |
| 18978408 | Background | Gill JB, Chin Y, Levin A, Feng D. The use of antifibrinolytic agents in spine surgery. A meta-analysis. J Bone Joint Surg Am. 2008 Nov;90(11):2399-407. doi: 10.2106/JBJS.G.01179. |
| 21289587 | Background | Tsutsumimoto T, Shimogata M, Ohta H, Yui M, Yoda I, Misawa H. Tranexamic acid reduces perioperative blood loss in cervical laminoplasty: a prospective randomized study. Spine (Phila Pa 1976). 2011 Nov 1;36(23):1913-8. doi: 10.1097/BRS.0b013e3181fb3a42. |
| 21102298 | Background | Halpin RJ, Sugrue PA, Gould RW, Kallas PG, Schafer MF, Ondra SL, Koski TR. Standardizing care for high-risk patients in spine surgery: the Northwestern high-risk spine protocol. Spine (Phila Pa 1976). 2010 Dec 1;35(25):2232-8. doi: 10.1097/BRS.0b013e3181e8abb0. |
| 18646174 | Background | Tzortzopoulou A, Cepeda MS, Schumann R, Carr DB. Antifibrinolytic agents for reducing blood loss in scoliosis surgery in children. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD006883. doi: 10.1002/14651858.CD006883.pub2. |
| 22104068 | Background | Dirkmann D, Gorlinger K, Gisbertz C, Dusse F, Peters J. Factor XIII and tranexamic acid but not recombinant factor VIIa attenuate tissue plasminogen activator-induced hyperfibrinolysis in human whole blood. Anesth Analg. 2012 Jun;114(6):1182-8. doi: 10.1213/ANE.0b013e31823b6683. Epub 2011 Nov 21. |
| 20402174 | Background | Ozier Y, Bellamy L. Pharmacological agents: antifibrinolytics and desmopressin. Best Pract Res Clin Anaesthesiol. 2010 Mar;24(1):107-19. doi: 10.1016/j.bpa.2009.09.014. |
Normal saline placebo loading dose 0.5ml/kg and infusion at 0.5ml/kg/hr throughout operative course Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight (kilogram) | Weight measured in kilograms | Mean | Standard Deviation | kilogram (kg) |
|
| Height (cm) | Mean | Standard Deviation | centimeters |
|
| Body Mass Index | Body mass index calculated by: kg/m^2 | Mean | Full Range | kg/m^2 |
|
| ASA status | American Society of Anesthesiologists Physical Status.
| Mean | Full Range | score on a scale |
|
| Medical History (none) | No contributory medical history. | Count of Participants | Participants |
|
| History of hypertension | Count of Participants | Participants |
|
| History of coronary artery disease | Count of Participants | Participants |
|
| History of atrial fibrillation | Count of Participants | Participants |
|
| History of peripheral vascular disease | Count of Participants | Participants |
|
| History of diabetes melitus | Count of Participants | Participants |
|
| History of asthma | Count of Participants | Participants |
|
| History of obstructive sleep apnea | Count of Participants | Participants |
|
| Baseline Hemoglobin (g/dl) | Hemoglobin measured as grams per deciliter/ | Mean | Standard Deviation | g/dl (grams per deciliter) |
|
| Baseline hematocrit | Baseline hematocrit in %. | Mean | Standard Deviation | Percent |
|
| Baseline Platelets | Baseline platelets x 10^5 cells/mm^3 | Mean | Inter-Quartile Range | x 10^5 cells/mm^3 |
|
| Baseline fibrinogen (mg/dL) | Fibrinogen measured in miligrams per deciliter. | Mean | Full Range | miligrams per deciliter |
|
| Preoperative risk of major transfusion | The preoperative risk of receiving a major blood transfusion described as percent risk. 0%= no preoperative risk- 100% high risk. Above 100%-600% very high risk. | Mean | Full Range | Percent |
|
| Total number of vertebral levels | Total number of vertebral levels operated upon. | Mean | Full Range | Vertebra levels |
|
|
|
|
| Secondary | Additional Blood Products Transfused | Total additional blood products (fresh frozen plasma, cryoprecipitate, and platelets) transfused in the perioperative period measured in units. | Posted | Mean | Full Range | Units | 24 hours after skin incision |
|
|
|
| Secondary | Post Operative Major Morbidity | Number of participants who experienced arterial or venous thromboembolism, neurologic complications (including stroke, seizure,and delirium), infections, and pulmonary renal or cardiac adverse outcomes (demand ischemia, myocardial infarction or new arrhythmia) before another operative procedure or hospital discharge. | Posted | Count of Participants | Participants | Time of surgery to date of discharge from hospital (average 7 days) |
|
|
|
| Other Pre-specified | Estimated Intraoperative Blood Loss | Estimated Intraoperative blood loss in milliliters (mLs) | Posted | Mean | 95% Confidence Interval | Milliliters | Incision to skin closure (approximately 10 hours) |
|
|
|
| Other Pre-specified | Total Tranexamic Acid Dose (mg) | Total milligrams of intravenous tranexamic acid administered during the surgical procedure. | Posted | Median | Full Range | milligrams | Intraoperative period |
|
|
|
| Post-Hoc | Total Operating Room Time | Total operating room time from incision to closure of incision in minutes. | Posted | Median | Full Range | Minutes | Minutes |
|
|
|
| 0 |
| 31 |
| 9 |
| 31 |
| 0 |
| 31 |
| EG001 | Placebo | Normal saline placebo loading dose 0.5ml/kg and infusion at 0.5ml/kg/hr throughout operative course Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure | 0 | 30 | 9 | 30 | 0 | 30 |
|
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