Back to results

Efficacy of Tranexamic Acid (TXA) in Humerus ORIF (TXA)

Primary Purpose

Fracture Humerus

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Tranexamic acid (TXA)

Saline

About this trial

This is an interventional treatment trial for Fracture Humerus focused on measuring Open Reduction Internal Fixation, Blood loss

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Males or females age 18-100 years Isolated proximal humerus or humeral shaft fracture undergoing open reduction internal fixation. Must be able to read and understand English and consent for themselves. Exclusion Criteria: Allergy to TXA. Acquired disturbances of color vision. History of arterial or venous thromboembolic disease; such as DVT, PE, CVA, TIA. Pregnant or breastfeeding. Recent MI (within 6 months of surgery) or any placement of stent regardless of time since placement. Renal impairment (creatinine above 1.2 in women, creatinine above 1.4 in men) Refusal of blood products Subarachnoid hemorrhage Disseminated intravascular coagulation

Sites / Locations

Allegheny Health Network Allegheny General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Arm

Control Group

Arm Description

Patients randomized to treatment arm of study will have TXA administered 10 minutes prior to surgery

The control group will have saline administered 10 minutes prior to surgery.

Outcomes

Primary Outcome Measures

Blood loss

The estimated total blood loss measured intraoperatively. This will be done by estimating absorbed drainage by surgical gauze and adding this to total volume in suction canister. Total volume of irrigation used will be subtracted from this total to give an estimate of intraoperative blood loss.

Secondary Outcome Measures

Operative Time

Amount of time of operative procedure

Duration of follow-up

Through study completion, an average of one year.

Complications (DVT, PE, stroke)

Presence or absence of the monitored complications (DVT, PE, stroke) will be recorded as a categorical data value.

Full Information

NCT ID

NCT05802238

First Posted

February 8, 2023

Last Updated

April 19, 2023

Sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

1. Study Identification

Unique Protocol Identification Number

NCT05802238

Brief Title

Efficacy of Tranexamic Acid (TXA) in Humerus ORIF

Acronym

TXA

Official Title

Efficacy of Tranexamic Acid (TXA) in Humerus ORIF

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 12, 2023 (Actual)

Primary Completion Date

June 30, 2028 (Anticipated)

Study Completion Date

June 30, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine if administration of tranexamic acid (TXA), a clotting agent, will decrease blood loss, the need for transfusion, and reduce the likelihood of wound complications such as infection. Investigators will also see if the drug can effectively decrease operative time and length of hospitalization.

Detailed Description

Single-center randomized controlled trial, parallel two-arm design allocation 1:1 exposed-control design to determine if TXA aids in prevention of blood loss in upper extremity trauma, specifically humerus fractures. Patient population includes male and female adults with no history of thromboses who suffered an isolated humeral injury. Patients will be evaluated at Allegheny General Hospital (AGH) as surgical candidates and allocated to the exposure group (receive TXA) or the control group (saline placebo). Patients randomized to treatment arm of study will have TXA administered 10 minutes prior to surgery. The control group will have saline administered 10 minutes prior to surgery. Patients will be seen in follow up at both 2 weeks and 6 weeks postoperatively, as well as followed through the electronic medical record (EMR).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fracture Humerus

Keywords

Open Reduction Internal Fixation, Blood loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Single-center randomized controlled trial, parallel two-arm design allocation 1:1 exposed-control design

Masking

None (Open Label)

Allocation

Randomized

Enrollment

130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment Arm

Arm Type

Experimental

Arm Description

Patients randomized to treatment arm of study will have TXA administered 10 minutes prior to surgery

Arm Title

Control Group

Arm Type

Placebo Comparator

Arm Description

The control group will have saline administered 10 minutes prior to surgery.

Intervention Type

Drug

Intervention Name(s)

Tranexamic acid (TXA)

Intervention Description

1 gram of TXA in 10mg single-dose ampule (100mg/mL) administered 10 minutes prior to surgery

Intervention Type

Other

Intervention Name(s)

Saline

Intervention Description

control group will receive 10 mL of normal saline infused intravenously at 1 mL/min.

Primary Outcome Measure Information:

Title

Blood loss

Description

Time Frame

Intraoperatively

Secondary Outcome Measure Information:

Title

Operative Time

Description

Amount of time of operative procedure

Time Frame

From the start of surgical procedure through the completion of the surgical procedure

Title

Duration of follow-up

Description

Through study completion, an average of one year.

Time Frame

Through study completion, an average of one year.

Title

Complications (DVT, PE, stroke)

Description

Presence or absence of the monitored complications (DVT, PE, stroke) will be recorded as a categorical data value.

Time Frame

through study completion, an average of one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pamela M. White, BSN

Phone

412-330-6044

Pamela.White2@ahn.org

First Name & Middle Initial & Last Name or Official Title & Degree

Peter Tang, MD

Phone

412-359-8098

Peter.Tang@ahn.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Tang, MD

Organizational Affiliation

Allegheny Health Network Allegheny General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Allegheny Health Network Allegheny General Hospital

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15212

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter Tang, MD

Phone

412-359-8098

Peter.Tang@ahn.org

First Name & Middle Initial & Last Name & Degree

Peter Tang, MD

First Name & Middle Initial & Last Name & Degree

Daniel Altman, MD

First Name & Middle Initial & Last Name & Degree

Gregory Altman, MD

First Name & Middle Initial & Last Name & Degree

Bradley Palmer, MD

First Name & Middle Initial & Last Name & Degree

Harrison Potak, MD

First Name & Middle Initial & Last Name & Degree

Steven Regal, MD

First Name & Middle Initial & Last Name & Degree

Michael Weiser, MS

First Name & Middle Initial & Last Name & Degree

Edward Westrick, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

28562553

Citation

Sun CX, Zhang L, Mi LD, Du GY, Sun XG, He SW. Efficiency and safety of tranexamic acid in reducing blood loss in total shoulder arthroplasty: A systematic review and meta-analysis. Medicine (Baltimore). 2017 Jun;96(22):e7015. doi: 10.1097/MD.0000000000007015.

Results Reference

background

PubMed Identifier

27435332

Citation

Akgul T, Buget M, Salduz A, Edipoglu IS, Ekinci M, Kucukay S, Sen C. Efficacy of preoperative administration of single high dose intravenous tranexamic acid in reducing blood loss in total knee arthroplasty: A prospective clinical study. Acta Orthop Traumatol Turc. 2016 Aug;50(4):429-31. doi: 10.1016/j.aott.2016.06.007. Epub 2016 Jul 16.

Results Reference

background

PubMed Identifier

25617507

Citation

Cheriyan T, Maier SP 2nd, Bianco K, Slobodyanyuk K, Rattenni RN, Lafage V, Schwab FJ, Lonner BS, Errico TJ. Efficacy of tranexamic acid on surgical bleeding in spine surgery: a meta-analysis. Spine J. 2015 Apr 1;15(4):752-61. doi: 10.1016/j.spinee.2015.01.013. Epub 2015 Jan 21.

Results Reference

background

PubMed Identifier

31902124

Citation

Yu X, Wang J, Wang X, Xie L, Chen C, Zheng W. The efficacy and safety of tranexamic acid in the treatment of intertrochanteric fracture: an updated meta-analysis of 11 randomized controlled trials. J Thromb Thrombolysis. 2020 Aug;50(2):243-257. doi: 10.1007/s11239-019-02034-1.

Results Reference

background

PubMed Identifier

30939507

Citation

Spitler CA, Row ER, Gardner WE 2nd, Swafford RE, Hankins MJ, Nowotarski PJ, Kiner DW. Tranexamic Acid Use in Open Reduction and Internal Fixation of Fractures of the Pelvis, Acetabulum, and Proximal Femur: A Randomized Controlled Trial. J Orthop Trauma. 2019 Aug;33(8):371-376. doi: 10.1097/BOT.0000000000001480.

Results Reference

background

PubMed Identifier

28983887

Citation

Baskaran D, Rahman S, Salmasi Y, Froghi S, Berber O, George M. Effect of tranexamic acid use on blood loss and thromboembolic risk in hip fracture surgery: systematic review and meta-analysis. Hip Int. 2018 Jan;28(1):3-10. doi: 10.5301/hipint.5000556.

Results Reference

background

PubMed Identifier

28938281

Citation

Gausden EB, Qudsi R, Boone MD, O'Gara B, Ruzbarsky JJ, Lorich DG. Tranexamic Acid in Orthopaedic Trauma Surgery: A Meta-Analysis. J Orthop Trauma. 2017 Oct;31(10):513-519. doi: 10.1097/BOT.0000000000000913.

Results Reference

background

PubMed Identifier

29337665

Citation

Franchini M, Mengoli C, Marietta M, Marano G, Vaglio S, Pupella S, Mannucci PM, Liumbruno GM. Safety of intravenous tranexamic acid in patients undergoing majororthopaedic surgery: a meta-analysis of randomised controlled trials. Blood Transfus. 2018 Jan;16(1):36-43. doi: 10.2450//2017.0219-17.

Results Reference

background

PubMed Identifier

28283245

Citation

Hooda B, Chouhan RS, Rath GP, Bithal PK, Suri A, Lamsal R. Effect of tranexamic acid on intraoperative blood loss and transfusion requirements in patients undergoing excision of intracranial meningioma. J Clin Neurosci. 2017 Jul;41:132-138. doi: 10.1016/j.jocn.2017.02.053. Epub 2017 Mar 7.

Results Reference

background

PubMed Identifier

29757132

Citation

Franchini M, Mengoli C, Cruciani M, Bergamini V, Presti F, Marano G, Pupella S, Vaglio S, Masiello F, Veropalumbo E, Piccinini V, Pati I, Liumbruno GM. Safety and efficacy of tranexamic acid for prevention of obstetric haemorrhage: an updated systematic review and meta-analysis. Blood Transfus. 2018 Jul;16(4):329-337. doi: 10.2450/2018.0026-18. Epub 2018 Apr 3.

Results Reference

background

PubMed Identifier

27626017

Citation

Ali Algadiem E, Aleisa AA, Alsubaie HI, Buhlaiqah NR, Algadeeb JB, Alsneini HA. Blood Loss Estimation Using Gauze Visual Analogue. Trauma Mon. 2016 May 3;21(2):e34131. doi: 10.5812/traumamon.34131. eCollection 2016 May.

Results Reference

background

PubMed Identifier

30516625

Citation

Goobie SM, Zurakowski D, Glotzbecker MP, McCann ME, Hedequist D, Brustowicz RM, Sethna NF, Karlin LI, Emans JB, Hresko MT. Tranexamic Acid Is Efficacious at Decreasing the Rate of Blood Loss in Adolescent Scoliosis Surgery: A Randomized Placebo-Controlled Trial. J Bone Joint Surg Am. 2018 Dec 5;100(23):2024-2032. doi: 10.2106/JBJS.18.00314.

Results Reference

background

PubMed Identifier

32713466

Citation

Cuff DJ, Simon P, Gorman RA 2nd. Randomized prospective evaluation of the use of tranexamic acid and effects on blood loss for proximal humeral fracture surgery. J Shoulder Elbow Surg. 2020 Aug;29(8):1627-1632. doi: 10.1016/j.jse.2020.04.016. Epub 2020 Jun 9.

Results Reference

background

PubMed Identifier

33194102

Citation

Yang YY, Qin H, Zheng X, Hu B, Zhang M, Ma T. Administration of Tranexamic Acid in Proximal Humeral Fractures. Indian J Orthop. 2020 May 11;54(Suppl 2):277-282. doi: 10.1007/s43465-020-00128-0. eCollection 2020 Dec.

Results Reference

background

Learn more about this trial

Efficacy of Tranexamic Acid (TXA) in Humerus ORIF

We'll reach out to this number within 24 hrs