NCT01850394

Brief Summary

The purpose of this study is to determine 1) the effective dosage of intra-articular tranexamic acid injection for controlling blood loss and blood transfusion requirement in conventional total knee replacement, and 2) whether the blood loss reduction effect depended on the dose of tranexamic acid used.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 9, 2013

Completed
7 months until next milestone

Results Posted

Study results publicly available

December 13, 2013

Completed
Last Updated

December 13, 2013

Status Verified

October 1, 2013

Enrollment Period

1 year

First QC Date

May 2, 2013

Results QC Date

May 9, 2013

Last Update Submit

October 24, 2013

Conditions

Primary Osteoarthritis of Knee Nos

Outcome Measures

Primary Outcomes (2)

  • Perioperative Blood Loss

    * Drainage blood loss measured by accumulating total drainage volume postoperatively * Calculated total blood loss measured by using specific formula and difference between hematocrit preoperatively and the fourth postoperative day

    5 days after surgery

  • Total Hemoglobin Loss

    Total hemoglobin loos measured by difference between hemoglobin preoperatively and the fourth postoperative day

    5 days after surgery

Secondary Outcomes (3)

  • Knee Function Scores

    1 year after surgery

  • Number of Patients Required Blood Transfusion

    postoperative period (5 days after surgery)

  • Number of Patients Having Postoperative Complications

    postoperative 1-year period

Study Arms (3)

Control group

PLACEBO COMPARATOR

physiologic saline 25 ml

Drug: Physiologic saline

TXA-250 group

ACTIVE COMPARATOR

A total of 25-ml solution with 250-mg tranexamic acid

Drug: Tranexamic AcidDrug: Physiologic saline

TXA-500 group

ACTIVE COMPARATOR

A total of 25-ml solution with 500-mg tranexamic acid

Drug: Tranexamic AcidDrug: Physiologic saline

Interventions

Tranexamic AcidDRUG

Inject tranexamic acid solution intra-articularly after fascia closure

Also known as: Transmin
TXA-250 groupTXA-500 group
Physiologic salineDRUG

Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

Control groupTXA-250 groupTXA-500 group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients diagnosed as primary knee osteoarthritis and underwent unilateral primary cemented conventional total knee replacement
  • no risk of abnormal bleeding tendency or bleeding disorder (normal coagulogram, serum creatinine \< 2.0 mg/dL, stop nonsteroidal anti-inflammatory drugs and antiplatelet drugs more than 7 days
  • no contra-indication for tranexamic acid use (no active intravascular clotting process, no acquired defective colour vision, no subarachnoid hemorrhage, no hypersensitivity to TXA, and no any of history of serious adverse effects, thrombotic disorder and hematuria)

You may not qualify if:

  • incomplete data collection, for example, malfunctioned drain or accidental drain removal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ramathibodi Hospital

Bangkok, 10400, Thailand

Location

Related Publications (7)

  • Sa-Ngasoongsong P, Channoom T, Kawinwonggowit V, Woratanarat P, Chanplakorn P, Wibulpolprasert B, Wongsak S, Udomsubpayakul U, Wechmongkolgorn S, Lekpittaya N. Postoperative blood loss reduction in computer-assisted surgery total knee replacement by low dose intra-articular tranexamic acid injection together with 2-hour clamp drain: a prospective triple-blinded randomized controlled trial. Orthop Rev (Pavia). 2011;3(2):e12. doi: 10.4081/or.2011.e12. Epub 2011 Jun 29.

    PMID: 22053253BACKGROUND

  • Ishida K, Tsumura N, Kitagawa A, Hamamura S, Fukuda K, Dogaki Y, Kubo S, Matsumoto T, Matsushita T, Chin T, Iguchi T, Kurosaka M, Kuroda R. Intra-articular injection of tranexamic acid reduces not only blood loss but also knee joint swelling after total knee arthroplasty. Int Orthop. 2011 Nov;35(11):1639-45. doi: 10.1007/s00264-010-1205-3. Epub 2011 Jan 21.

    PMID: 21253725BACKGROUND

  • 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.

    PMID: 21048170BACKGROUND

  • Maniar RN, Kumar G, Singhi T, Nayak RM, Maniar PR. Most effective regimen of tranexamic acid in knee arthroplasty: a prospective randomized controlled study in 240 patients. Clin Orthop Relat Res. 2012 Sep;470(9):2605-12. doi: 10.1007/s11999-012-2310-y. Epub 2012 Mar 15.

    PMID: 22419350BACKGROUND

  • Roy SP, Tanki UF, Dutta A, Jain SK, Nagi ON. Efficacy of intra-articular tranexamic acid in blood loss reduction following primary unilateral total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2012 Dec;20(12):2494-501. doi: 10.1007/s00167-012-1942-5. Epub 2012 Mar 15.

    PMID: 22419263BACKGROUND

  • Seo JG, Moon YW, Park SH, Kim SM, Ko KR. The comparative efficacies of intra-articular and IV tranexamic acid for reducing blood loss during total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2013 Aug;21(8):1869-74. doi: 10.1007/s00167-012-2079-2. Epub 2012 Jun 24.

    PMID: 22729012BACKGROUND

  • Sa-Ngasoongsong P, Wongsak S, Chanplakorn P, Woratanarat P, Wechmongkolgorn S, Wibulpolprasert B, Mulpruek P, Kawinwonggowit V. Efficacy of low-dose intra-articular tranexamic acid in total knee replacement; a prospective triple-blinded randomized controlled trial. BMC Musculoskelet Disord. 2013 Dec 5;14:340. doi: 10.1186/1471-2474-14-340.

    PMID: 24308672DERIVED

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Results Point of Contact

Title
Dr. Paphon Sa-ngasoongsong
Organization
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
chan3s@hotmail.com
66-2-2011589

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 2, 2013

First Posted

May 9, 2013

Study Start

January 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2012

Last Updated

December 13, 2013

Results First Posted

December 13, 2013

Record last verified: 2013-10

Locations

TH(1)