Tranexamic Acid Dosing in Adult Spinal Deformity Surgery

NCT02053363 | Completed Phase 2 Results DMC

• 1 other identifier: 201312010
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate two dosing protocols for tranexamic acid (TXA), an anti-fibrinolytic used to decrease blood loss in adult patients undergoing complex, reconstructive spinal fusion surgeries.

Conditions

Adult Spinal Deformity

Keywords

tranexamic acid, reconstructive spine surgery

Outcome Measures

Primary Outcomes (1)

• Blood Loss

  To compare the estimated blood loss in patients undergoing complex, reconstructive, spinal fusion surgeries receiving one of two dosing protocols for the anti-fibrinolytic, TXA. Estimated blood loss was calculated by suction canister volume minus intraoperative irrigation fluid plus blood content in sponges as estimated by weight for all cases.

  This outcome is measured during surgery, from exposure to wound closure, approximately 8 hours.

Secondary Outcomes (2)

• Red Blood Cell Transfusions

  Participants will be followed for the duration of their hospital stay measured from day of surgery to day of discharge from the hospital, approximately 7 days.

• Number of Patients Sustaining Intraoperative or 90 Day Complications

  Perioperative complications were defined as complications occurring within 90 days of surgery.

Study Arms (2)

High Dose/Study Group

EXPERIMENTAL

Tranexamic Acid (Cyklokapron) Loading Dose 50mg/kg given over 15 minutes, followed by 5mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.

Drug: Tranexamic Acid (Cyklokapron)

Standard of Care/Control

ACTIVE COMPARATOR

Tranexamic Acid (Cyklokapron) Loading Dose 10mg/kg given over 15 minutes, followed by 1mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.

Drug: Tranexamic Acid (Cyklokapron)

Interventions

Tranexamic Acid (Cyklokapron) DRUG

High Dose/Study Group; Standard of Care/Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (ages 18-75) scheduled to undergo long segment (greater than 8 motion segments) posterior spinal fusion with instrumentation (PSF) for adult scoliosis

You may not qualify if:

• Patients with acquired defective color vision
• Subarachnoid hemorrhage
• Active intravascular clotting
• Hypersensitivity to tranexamic acid or any of the ingredients
• Patients who pre-donate autologous blood for intra- or post-operative use (Directed donor units are acceptable)
• History of suspected blood disorders or abnormal coagulation laboratory results
• Current anticoagulation therapy that cannot be interrupted
• History of deep vein thrombosis (DVT)
• Impaired renal function or creatinine clearance \<60 ml/min
• Pregnancy or women who are lactating/breastfeeding
• Women on hormonal contraceptives

Sponsors & Collaborators

• Washington University School of Medicine: lead
• AOSpine North America: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (12)

• Baldus CR, Bridwell KH, Lenke LG, Okubadejo GO. Can we safely reduce blood loss during lumbar pedicle subtraction osteotomy procedures using tranexamic acid or aprotinin? A comparative study with controls. Spine (Phila Pa 1976). 2010 Jan 15;35(2):235-9. doi: 10.1097/BRS.0b013e3181c86cb9.

  PMID: 20081519 BACKGROUND

• Neilipovitz DT. Tranexamic acid for major spinal surgery. Eur Spine J. 2004 Oct;13 Suppl 1(Suppl 1):S62-5. doi: 10.1007/s00586-004-0716-2. Epub 2004 May 4.

  PMID: 15127250 BACKGROUND

• Okubadejo GO, Bridwell KH, Lenke LG, Buchowski JM, Fang DD, Baldus CR, Nielsen CH, Lee CC. Aprotinin may decrease blood loss in complex adult spinal deformity surgery, but it may also increase the risk of acute renal failure. Spine (Phila Pa 1976). 2007 Sep 15;32(20):2265-71. doi: 10.1097/BRS.0b013e31814ce9b0.

  PMID: 17873821 BACKGROUND

• Berenholtz SM, Pham JC, Garrett-Mayer E, Atchison CW, Kostuik JP, Cohen DB, Nundy S, Dorman T, Ness PM, Klag MJ, Pronovost PJ, Kebaish KM. Effect of epsilon aminocaproic acid on red-cell transfusion requirements in major spinal surgery. Spine (Phila Pa 1976). 2009 Sep 1;34(19):2096-103. doi: 10.1097/BRS.0b013e3181b1fab2.

  PMID: 19730217 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.

  PMID: 19011538 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.

  PMID: 18978408 BACKGROUND

• Neilipovitz DT, Murto K, Hall L, Barrowman NJ, Splinter WM. A randomized trial of tranexamic acid to reduce blood transfusion for scoliosis surgery. Anesth Analg. 2001 Jul;93(1):82-7. doi: 10.1097/00000539-200107000-00018.

  PMID: 11429344 BACKGROUND

• Sethna NF, Zurakowski D, Brustowicz RM, Bacsik J, Sullivan LJ, Shapiro F. Tranexamic acid reduces intraoperative blood loss in pediatric patients undergoing scoliosis surgery. Anesthesiology. 2005 Apr;102(4):727-32. doi: 10.1097/00000542-200504000-00006.

  PMID: 15791100 BACKGROUND

• Shapiro F, Zurakowski D, Sethna NF. Tranexamic acid diminishes intraoperative blood loss and transfusion in spinal fusions for duchenne muscular dystrophy scoliosis. Spine (Phila Pa 1976). 2007 Sep 15;32(20):2278-83. doi: 10.1097/BRS.0b013e31814cf139.

  PMID: 17873823 BACKGROUND

• Grant JA, Howard J, Luntley J, Harder J, Aleissa S, Parsons D. Perioperative blood transfusion requirements in pediatric scoliosis surgery: the efficacy of tranexamic acid. J Pediatr Orthop. 2009 Apr-May;29(3):300-4. doi: 10.1097/BPO.0b013e31819a85de.

  PMID: 19305284 BACKGROUND

• Goobie SM, Meier PM, Pereira LM, McGowan FX, Prescilla RP, Scharp LA, Rogers GF, Proctor MR, Meara JG, Soriano SG, Zurakowski D, Sethna NF. Efficacy of tranexamic acid in pediatric craniosynostosis surgery: a double-blind, placebo-controlled trial. Anesthesiology. 2011 Apr;114(4):862-71. doi: 10.1097/ALN.0b013e318210fd8f.

  PMID: 21364458 BACKGROUND

• Clohisy JCF, Lenke LG, Dafrawy MHE, Wolfe RC, Frazier E, Kelly MP. Randomized, controlled trial of two tranexamic acid dosing protocols in adult spinal deformity surgery. Spine Deform. 2022 Nov;10(6):1399-1406. doi: 10.1007/s43390-022-00539-z. Epub 2022 Jun 25.

  PMID: 35751772 DERIVED

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Limitations and Caveats

Our sample size estimation underestimated the standard deviation of mean EBL in both groups. This resulted in an underpowered study.

Results Point of Contact

• Title: Michael P Kelly
• Organization: Rady Children's Hospital

mkelly5@rchsd.org

858-576-1700

Study Officials

• Michael P. Kelly, MD, MSCI(p)

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: February 3, 2014
• Study Start: March 1, 2014
• Primary Completion: June 26, 2020
• Study Completion: June 26, 2020
• Last Updated: June 8, 2022
• Results First Posted: June 8, 2022

Record last verified: 2022-05

Locations

US (1)