Effectiveness Study of the Drug Tranexamic Acid to Reduce Post-surgery Blood Loss in Spinal Surgery

Lumbar Spinal Stenosis Clinical Trial

Official title:

Topical Application of Tranexamic Acid to Reduce Postoperative Blood Loss in Posterior Approach Spinal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063035
• Other study ID #: 2012P000266
• Secondary ID: 2012P000266
• Status: Completed
• Phase: Phase 4
• First received: December 19, 2013
• Last updated: June 6, 2017
• Start date: August 2012
• Est. completion date: April 22, 2015

Study information

• Verified date: June 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis
• Thoracic Spinal Stenosis

Intervention

Drug:
• Tranexamic Acid
A single topical application of 3 grams (g) of Tranexamic acid in 100 milliliter (mL) saline.
• Placebo
A single topical application of matching placebo, which is 100 mL of normal saline.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Orthopedic Spine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (10)

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

Outcome

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