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

• ClinicalTrials.gov Identifier: NCT02063035
• Recruitment Status: Completed
• First Posted: February 14, 2014
• Results First Posted: June 8, 2017
• Last Update Posted: June 8, 2017
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Kirkham Wood, Massachusetts General Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lumbar Spinal Stenosis; Thoracic Spinal Stenosis	Drug: Tranexamic Acid; Drug: Placebo	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Topical Application of Tranexamic Acid to Reduce Postoperative Blood Loss in Posterior Approach Spinal Surgery
• Actual Study Start Date: August 2012
• Actual Primary Completion Date: April 22, 2015
• Actual Study Completion Date: April 22, 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Tranexamic acid; Participants undergoing spinal surgery will receive a single, topical dose of tranexamic acid. The surgeon will irrigate the study medication in the wound prior to closure, and aspirate it after five minutes. Drains will be placed after the study drug has been aspirated.	Drug: Tranexamic Acid; A single topical application of 3 grams (g) of Tranexamic acid in 100 milliliter (mL) saline.; Other Name: Cyklokapron®
Placebo Comparator: Placebo; Participants undergoing spinal surgery will receive a single, topical dose of matching placebo. The surgeon will irrigate the study medication in the wound prior to closure, and aspirate it after five minutes. Drains will be placed after the study drug has been aspirated.	Drug: Placebo; A single topical application of matching placebo, which is 100 mL of normal saline.

Outcome Measures

Primary Outcome Measures :

1. Change in Hemoglobin Level From Preoperative Appointment to Postoperative Hospital Discharge [ Time Frame: 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 Outcome Measures :

1. Blood Loss Volume Following Surgery [ Time Frame: 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.
2. Hospital Length of Stay in Days [ Time Frame: 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.
3. Post-operative Blood Transfusions During Hospitalization [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Massachusetts

Massachusetts General Hospital Orthopedic Spine

Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

• Principal Investigator: Kirkham B Wood, MD; Massachusetts General Hospital

More Information

Publications:

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.

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.

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. doi: 10.1097/01.brs.0000175188.05542.a9.

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. doi: 10.1308/147870805X28118.

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.

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.

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. No abstract available.

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. doi: 10.1097/00000542-200611000-00026.

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.

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.

• Responsible Party: Kirkham Wood, Associate Professor at Harvard Medical School, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02063035
• Other Study ID Numbers: 2012P000266; 2012P000266 ( Other Identifier: Massachusetts General Hospital IRB approved )
• First Posted: February 14, 2014
• Results First Posted: June 8, 2017
• Last Update Posted: June 8, 2017
• Last Verified: June 2017

Keywords provided by Kirkham Wood, Massachusetts General Hospital:

lumbar spine surgery; thoracic spine surgery

Additional relevant MeSH terms:

Spinal Stenosis; Constriction, Pathologic; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Tranexamic Acid; Antifibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Hemostatics; Coagulants