Curvature of Spine Clinical Trial
— TXAOfficial title:
The Use of Tranexamic Acid to Reduce Perioperative Blood Loss During High Risk Spine Fusion Surgery
| Verified date | January 2021 |
| Source | Northwestern University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 61 |
| Est. completion date | December 30, 2017 |
| Est. primary completion date | December 30, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - age>17 years - undergoing posterior spine fusion surgery for kyphoscoliosis with a >80% chance of major transfusion Exclusion Criteria: - age < 18 years - non-English speaking - pregnancy - emergency procedures - surgery for tumor, trauma or infection - severe coronary artery disease - history of venous thromboembolism - history of cerebral vascular accident - history of renal insufficiency - allergy to tranexamic acid |
| Country | Name | City | State |
|---|---|---|---|
| United States | Northwestern Memorial Hospital | Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| Northwestern University |
United States,
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. — View Citation
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, Mejía-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. — View Citation
Dirkmann D, Görlinger 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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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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. Review. — View Citation
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. Review. — View Citation
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. Review. Update in: Cochrane Database Syst Rev. 2011;(1):CD001886. — View Citation
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. Review. — View Citation
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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. Review. — View Citation
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. — View Citation
* Note: There are 16 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Estimated Intraoperative Blood Loss | Estimated Intraoperative blood loss in milliliters (mLs) | Incision to skin closure (approximately 10 hours) | |
| Other | Total Tranexamic Acid Dose (mg) | Total milligrams of intravenous tranexamic acid administered during the surgical procedure. | Intraoperative period | |
| 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. | Intraoperative period (approximately 12 hours) | |
| Secondary | 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 | |
| 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. | Time of surgery to date of discharge from hospital (average 7 days) |