NCT03954860

Brief Summary

The objective of this study was to evaluate the safety and efficacy of topical combined with intravenous tranexamic acid for high tibial osteotomy without placement of a drainage tube The clinical scores of patients and their possible risks were tracked. The investigators hypothesized that a combination of tranexamic acid and no drainage tube could reduce blood loss and facilitate early recovery. The implementation of the study will provide a new perioperative blood loss control program for High Tibial Osteotomy, reduce the cost of hospitalization, promote patients to get out of bed early, reduce the number of days in hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

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

August 1, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 17, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

February 19, 2020

Status Verified

May 1, 2019

Enrollment Period

1.1 years

First QC Date

May 6, 2019

Last Update Submit

February 16, 2020

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (15)

  • Postoperative blood loss

    Total blood loss preoperative blood volume =(preoperative hematocrit-postoperative Hematocrit) + transfusion volume.

    The third day after operation

  • Haemoglobin

    Reactive blood loss

    The third day after operation

  • Hematocrit

    Reactive blood loss

    The third day after operation

  • Hospital for special surgery knee score

    HSS is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.

    postoperative 3 month

  • Visual Analogue Scale Postoperative Day One

    Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.

    Postoperative Day One

  • Visual Analogue Scale Postoperative Day Three

    Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.

    Postoperative Day Three

  • Visual Analogue Scale Postoperative Day Five

    Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.

    Postoperative Day Five

  • Circumference of shank Postoperative Day One

    indirectly reflects the latent blood loss

    Postoperative Day One

  • Circumference of shank Postoperative Day Three

    indirectly reflects the latent blood loss

    Postoperative Day Three

  • Circumference of shank Postoperative Day Five

    indirectly reflects the latent blood loss

    Postoperative Day Five

  • Number of blood transfusions

    If the hemoglobin was \<80 g/l, allogeneic blood was transfused, and the number of blood transfusions were recorded.0 means no blood transfusion, and the larger the number is, the more blood transfusion.The maximum number does not exceed the total number of patients

    Postoperative Day Three

  • Number of Incision infection

    The incision was red, swollen, hot and painful, and the blood routine showed that the leukocyte was increased.

    postoperative 3 month

  • Number of hematoma formation

    After operation, the incision is swollen and has wave motion, but it is not hot or painful, and there will be blood outflow during puncture.

    postoperative 3 month

  • Number of delayed healing of the incision.

    On the 14th day after operation, the incision did not heal.

    On the 14th day after operation

  • Volume of drainage

    Reactive blood loss

    Postoperative Day One

Secondary Outcomes (4)

  • Activated partial thromboplastin time

    The third day after operation

  • Prothrombin time

    The third day after operation

  • Concentration of D-dimer

    The third day after operation

  • Concentration of Fibrinogen

    The third day after operation

Study Arms (2)

No Drainage

EXPERIMENTAL

The preoperative dose of tranexamic acid was calculated according to 20 mg / kg body weight, 100 ml of tranexamic acid sodium chloride solution was dripped 30 minutes before operation, and 30 ml saline containing 2 g tranexamic acid was applied to the local area before loosening the tourniquet.Postoperative intravenous drip of 100 ML sodium chloride solution containing 20 mg / kg tranexamic acid. No drainage tube was placed after operation.

Drug: Tranexamic AcidDrug: Sodium Chloride 0.9%

Drainage

ACTIVE COMPARATOR

The preoperative dose of tranexamic acid was calculated according to 20 mg / kg body weight, 100 ml of tranexamic acid sodium chloride solution was dripped 30 minutes before operation, and 30 ml saline containing 2 g tranexamic acid was applied to the local area before loosening the tourniquet.Postoperative intravenous drip of 100 ML sodium chloride solution containing 20 mg / kg tranexamic acid. Drainage tube should be placed after operation.

Other: Drainage TubeDrug: Tranexamic AcidDrug: Sodium Chloride 0.9%

Interventions

Drainage TubeOTHER

The drainage tube drainage to guide the pus, blood and liquid accumulated between human tissues or in body cavity outside the body of High tibial osteotomy'patients.

Drainage
Tranexamic AcidDRUG

Tranexamic acid (TXA) is an anti-fibrinolytic drugcan，which can increase the stability of fibrin clots and achieve hemostasis for High tibial osteotomy'patients.

Also known as: TXA
DrainageNo Drainage
Sodium Chloride 0.9%DRUG

Sodium Chloride 0.9% is a solution of sodium chloride, which has the same osmotic pressure as animal or human plasma in physiological experiments or clinics, and can be used to dilute Tranexamic Acid .

Also known as: sodium chloride solution
DrainageNo Drainage

Eligibility Criteria

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

You may qualify if:

  • Simple knee medial compartment osteoarthritis High tibial osteotomy.
  • With varus deformity, medial proximal tibia angle \<85°
  • Unilateral High tibial osteotomy
  • informed consent: Participants must be able to understand and voluntarily sign a written informed consent and follow the research protocol and interview process

You may not qualify if:

  • patients who underwent other knee surgery within 6 months
  • Preoperative combined anemia (Hb\<100g/l)
  • Patients with severe cardiovascular, hepatic, renal and hematopoietic diseases
  • Patient with preoperative coagulation abnormalities 5. Patients with allergies and patients allergic to TXA.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu hospital of Shandong University

Jinan, Shandong, 250014, China

Location

Related Publications (9)

  • Kim KI, Kim HJ, Kim GB, Bae SH. Tranexamic acid is effective for blood management in open-wedge high tibial osteotomy. Orthop Traumatol Surg Res. 2018 Nov;104(7):1003-1007. doi: 10.1016/j.otsr.2018.07.019. Epub 2018 Sep 20.

    PMID: 30245067BACKGROUND

  • Palanisamy JV, Das S, Moon KH, Kim DH, Kim TK. Intravenous Tranexamic Acid Reduces Postoperative Blood Loss After High Tibial Osteotomy. Clin Orthop Relat Res. 2018 Nov;476(11):2148-2154. doi: 10.1097/CORR.0000000000000378.

    PMID: 29939895BACKGROUND

  • Suh DW, Kyung BS, Han SB, Cheong K, Lee WH. Efficacy of Tranexamic Acid for Hemostasis in Patients Undergoing High Tibial Osteotomy. J Knee Surg. 2018 Jan;31(1):50-55. doi: 10.1055/s-0037-1600091. Epub 2017 Mar 29.

    PMID: 28355682BACKGROUND

  • Zhang Q, Zhang Q, Guo W, Liu Z, Cheng L, Zhu G. No need for use of drainage after minimally invasive unicompartmental knee arthroplasty: a prospective randomized, controlled trial. Arch Orthop Trauma Surg. 2015 May;135(5):709-13. doi: 10.1007/s00402-015-2192-z. Epub 2015 Mar 8.

    PMID: 25750137BACKGROUND

  • Huang Z, Xie X, Li L, Huang Q, Ma J, Shen B, Kraus VB, Pei F. Intravenous and Topical Tranexamic Acid Alone Are Superior to Tourniquet Use for Primary Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial. J Bone Joint Surg Am. 2017 Dec 20;99(24):2053-2061. doi: 10.2106/JBJS.16.01525.

    PMID: 29257010BACKGROUND

  • Chan JJ, Cirino CM, Huang HH, Poeran J, Mazumdar M, Parsons BO, Anthony SG, Galatz LM, Cagle PJ Jr. Drain Use is Associated with Increased Odds of Blood Transfusion in Total Shoulder Arthroplasty: A Population-Based Study. Clin Orthop Relat Res. 2019 Jul;477(7):1700-1711. doi: 10.1097/CORR.0000000000000728.

    PMID: 30985612BACKGROUND

  • Legnani C, Oriani G, Parente F, Ventura A. Reducing transfusion requirements following total knee arthroplasty: effectiveness of a double infusion of tranexamic acid. Eur Rev Med Pharmacol Sci. 2019 Mar;23(5):2253-2256. doi: 10.26355/eurrev_201903_17273.

    PMID: 30915773BACKGROUND

  • Nishitani K, Kuriyama S, Nakamura S, Ito H, Matsuda S. A Multivariate Analysis on the Effect of No Closed Suction Drain on the Length of Hospital Stay in Total Knee Arthroplasty. Knee Surg Relat Res. 2019 Mar 1;31(1):25-30. doi: 10.5792/ksrr.18.013.

    PMID: 30871289BACKGROUND

  • Li S, Yang J, Watson C, Lu Q, Zhang M, Miao Z, Luo D, Liu P. Drainage relieves pain without increasing post-operative blood loss in high tibial osteotomy: a prospective randomized controlled study. Int Orthop. 2020 Jun;44(6):1037-1043. doi: 10.1007/s00264-020-04530-z. Epub 2020 Mar 14.

    PMID: 32172314DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Tranexamic AcidSodium Chloride

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Peilai Liu, Ph.D

    Qilu Hospital of Shandong University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2019

First Posted

May 17, 2019

Study Start

August 1, 2018

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

February 19, 2020

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

The datasets used and/or analysed during the current study are available from the overall study officials on reasonable request.

Locations

CN(1)