NCT03915756

Brief Summary

The investigator's aim with this study is to address, with the new paradigm of tranexamic acid, the role of wound drainage following total knee arthroplasty in blood loss, blood transfusion requirements and functional recovery

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

August 22, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

February 15, 2021

Status Verified

February 1, 2021

Enrollment Period

2.7 years

First QC Date

April 12, 2019

Last Update Submit

February 12, 2021

Conditions

Osteoarthritis, Knee

Keywords

Knee replacementBlood lossWound drainage

Outcome Measures

Primary Outcomes (5)

  • Total RBC loss

    Total red blood cells loss after surgery

    96 hours

  • Total RBC loss

    Total red blood cells loss after surgery

    24 hours

  • Total RBC loss

    Total red blood cells loss after surgery

    1 hour

  • Blood transfusion requirements

    Blood transfusions requirements

    96 hours

  • Knee Society Score score

    Knee Society Score measuring function of Knee (0-100 total score, higher values, better outcome)

    14 days

Secondary Outcomes (22)

  • Haematocrit level

    1 hour

  • Haematocrit level

    24 hours

  • Haematocrit level

    96 hours

  • Haemoglobin level

    1 hour

  • Haemoglobin level

    24 hours

  • +17 more secondary outcomes

Study Arms (2)

With drain

EXPERIMENTAL

Participants who received a drain during surgery

Procedure: Drainage of surgical wound

Without drain

NO INTERVENTION

Participants who did not receive a drain during surgery

Interventions

Drainage of surgical woundPROCEDURE

Introduction of a drain before full fascial closure

With drain

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive patients admitted to perform a primary unilateral total knee arthroplasty

You may not qualify if:

  • Contraindication to take tranexamic acid
  • hematologic disease with a higher risk of bleeding
  • abnormal coagulation tests
  • refusal of blood transfusions
  • inadequate preoperatory optimization
  • deformity \>15⁰ of varus or valgus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Beatriz Angelo

Loures, 2674-514, Portugal

RECRUITING

Related Publications (11)

  • Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.

    PMID: 24553908BACKGROUND

  • NIH Consensus Panel. NIH Consensus Statement on total knee replacement December 8-10, 2003. J Bone Joint Surg Am. 2004 Jun;86(6):1328-35. doi: 10.2106/00004623-200406000-00031. No abstract available.

    PMID: 15173310BACKGROUND

  • Banerjee S, Kapadia BH, Issa K, McElroy MJ, Khanuja HS, Harwin SF, Mont MA. Postoperative blood loss prevention in total knee arthroplasty. J Knee Surg. 2013 Dec;26(6):395-400. doi: 10.1055/s-0033-1357491. Epub 2013 Oct 11.

    PMID: 24122437BACKGROUND

  • Huang GP, Jia XF, Xiang Z, Ji Y, Wu GY, Tang Y, Li J, Zhang J. Tranexamic Acid Reduces Hidden Blood Loss in Patients Undergoing Total Knee Arthroplasty: A Comparative Study and Meta-Analysis. Med Sci Monit. 2016 Mar 10;22:797-802. doi: 10.12659/msm.895571.

    PMID: 26961597BACKGROUND

  • 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.

    PMID: 25450009BACKGROUND

  • Zhang Y, Zhang JW, Wang BH. Efficacy of tranexamic acid plus drain-clamping to reduce blood loss in total knee arthroplasty: A meta-analysis. Medicine (Baltimore). 2017 Jun;96(26):e7363. doi: 10.1097/MD.0000000000007363.

    PMID: 28658157BACKGROUND

  • Liao L, Chen Y, Tang Q, Chen YY, Wang WC. Tranexamic acid plus drain-clamping can reduce blood loss in total knee arthroplasty: A systematic review and meta-analysis. Int J Surg. 2018 Apr;52:334-341. doi: 10.1016/j.ijsu.2018.01.040. Epub 2018 Feb 3.

    PMID: 29408472BACKGROUND

  • Craik JD, Ei Shafie SA, Kidd AG, Twyman RS. Can local administration of tranexamic acid during total knee arthroplasty reduce blood loss and transfusion requirements in the absence of surgical drains? Eur J Orthop Surg Traumatol. 2014 Apr;24(3):379-84. doi: 10.1007/s00590-013-1206-1. Epub 2013 Mar 14.

    PMID: 23494778BACKGROUND

  • Yang Y, Lv YM, Ding PJ, Li J, Ying-Ze Z. The reduction in blood loss with intra-articular injection of tranexamic acid in unilateral total knee arthroplasty without operative drains: a randomized controlled trial. Eur J Orthop Surg Traumatol. 2015 Jan;25(1):135-9. doi: 10.1007/s00590-014-1461-9. Epub 2014 May 10.

    PMID: 24816760BACKGROUND

  • Gao FQ, Li ZJ, Zhang K, Sun W, Zhang H. Four Methods for Calculating Blood-loss after Total Knee Arthroplasty. Chin Med J (Engl). 2015 Nov 5;128(21):2856-60. doi: 10.4103/0366-6999.168041.

    PMID: 26521781BACKGROUND

  • Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.

    PMID: 21936146BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneeHemorrhage

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Afonso Cardoso

    Hospital Beatriz Angelo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Afonso Cardoso

CONTACT

00351918972882afonso.cardoso@hbeatrizangelo.pt

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 12, 2019

First Posted

April 16, 2019

Study Start

August 22, 2019

Primary Completion

May 1, 2022

Study Completion

July 1, 2022

Last Updated

February 15, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)