Lumbar Spinal Stenosis Clinical Trial
Official title:
Topical Application of Tranexamic Acid to Reduce Postoperative Blood Loss in Posterior Approach Spinal Surgery
Verified date | June 2017 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 29 |
Est. completion date | April 22, 2015 |
Est. primary completion date | April 22, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital Orthopedic Spine | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
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
Fawzy H, Elmistekawy E, Bonneau D, Latter D, Errett L. Can local application of Tranexamic acid reduce post-coronary bypass surgery blood loss? A randomized controlled trial. J Cardiothorac Surg. 2009 Jun 18;4:25. doi: 10.1186/1749-8090-4-25. — View Citation
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. Review. — View Citation
Hynes MC, Calder P, Rosenfeld P, Scott G. The use of tranexamic acid to reduce blood loss during total hip arthroplasty: an observational study. Ann R Coll Surg Engl. 2005 Mar;87(2):99-101. — View Citation
Ipema HJ, Tanzi MG. Use of topical tranexamic acid or aminocaproic acid to prevent bleeding after major surgical procedures. Ann Pharmacother. 2012 Jan;46(1):97-107. doi: 10.1345/aph.1Q383. Epub 2011 Dec 27. Review. — View Citation
Raveendran R, Wong J. Tranexamic acid reduces blood transfusion in surgical patients while its effects on thromboembolic events and mortality are uncertain. Evid Based Med. 2013 Apr;18(2):65-6. doi: 10.1136/eb-2012-100872. Epub 2012 Aug 4. — View Citation
Thompson GH, Florentino-Pineda I, Poe-Kochert C. The role of amicar in decreasing perioperative blood loss in idiopathic scoliosis. Spine (Phila Pa 1976). 2005 Sep 1;30(17 Suppl):S94-9. — View Citation
Wang H, Shen B, Zeng Y. Comparison of topical versus intravenous tranexamic acid in primary total knee arthroplasty: a meta-analysis of randomized controlled and prospective cohort trials. Knee. 2014 Dec;21(6):987-93. doi: 10.1016/j.knee.2014.09.010. Epub 2014 Oct 23. Review. — View Citation
Wong J, Abrishami A, El Beheiry H, Mahomed NN, Roderick Davey J, Gandhi R, Syed KA, Muhammad Ovais Hasan S, De Silva Y, Chung F. Topical application of tranexamic acid reduces postoperative blood loss in total knee arthroplasty: a randomized, controlled trial. J Bone Joint Surg Am. 2010 Nov 3;92(15):2503-13. doi: 10.2106/JBJS.I.01518. — View Citation
Zufferey P, Merquiol F, Laporte S, Decousus H, Mismetti P, Auboyer C, Samama CM, Molliex S. Do antifibrinolytics reduce allogeneic blood transfusion in orthopedic surgery? Anesthesiology. 2006 Nov;105(5):1034-46. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | From preoperative appointment approximately one week before surgery to end of hospital stay up to approximately 5 days after surgery | |
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. | From end of surgery on Day 1 to end of hospital stay up to approximately 5 days | |
Secondary | Hospital Length of Stay in Days | The number of days the participants stayed in the hospital after surgery was recorded. | From end of surgery on Day 1 to end of hospital stay up to approximately 2 weeks | |
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. | From end of surgery on Day 1 to end of hospital stay up to approximately 5 days |
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