NCT01370460

Brief Summary

This study aims to assess postoperative blood loss and transfusion rates in total knee replacement after one-time administration of topical tranexamic acid.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_2

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

June 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 10, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
10 months until next milestone

Results Posted

Study results publicly available

July 9, 2013

Completed
Last Updated

April 25, 2023

Status Verified

March 1, 2023

Enrollment Period

1.3 years

First QC Date

June 3, 2011

Results QC Date

March 27, 2013

Last Update Submit

March 30, 2023

Conditions

Acute Blood Loss AnemiaOsteoarthritis, Knee

Keywords

Tranexamic AcidBlood transfusionTotal knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Blood Loss

    Preoperative and lowest postoperative hemoglobin. Blood loss was calculated taking change in hemoglobin as described (units g/dL) and converting to blood loss (mL) according to the formulas included in the papers cited in this entry (Good 2003 Br J Anesthesia; Nadler 1962 Surgery, http://www.ncbi.nlm.nih.gov/pubmed/21936146).

    participants will be followed for the duration of hospital stay, an expected average of 3 days

Secondary Outcomes (1)

  • Postoperative Transfusion Rate

    participants will be followed for the duration of hospital stay, an expected average of 3 days

Study Arms (2)

Tranexamic Acid

EXPERIMENTAL

Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.

Drug: Tranexamic Acid

Placebo

PLACEBO COMPARATOR

100mL 0.9% NS, applied topically

Drug: Placebo

Interventions

Tranexamic AcidDRUG

Topical tranexamic acid (2g/100mL 0.9% saline)

Also known as: Cyklokapron
Tranexamic Acid
PlaceboDRUG

100mL 0.9% sterile saline

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult patients over age eighteen
  • Primary unilateral total knee arthroplasty at Henry Ford Hospital (Detroit, Michigan, United States) and Henry Ford West Bloomfield Hospital (West Bloomfield, Michigan, United States)

You may not qualify if:

  • patient history of venous thromboembolic disease or coagulopathy
  • use of anticoagulant medications within 7 days of surgery
  • history of arterial embolic disease
  • history of Class III or IV heart failure
  • renal failure
  • intraoperative cardiovascular, pulmonary, orthopaedic, or anesthetic complication (MI, intraoperative fracture, vasopressor support, emergent intubation).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related Publications (2)

  • 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

  • Good L, Peterson E, Lisander B. Tranexamic acid decreases external blood loss but not hidden blood loss in total knee replacement. Br J Anaesth. 2003 May;90(5):596-9. doi: 10.1093/bja/aeg111.

    PMID: 12697586BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Results Point of Contact

Title
Andrew Georgiadis, MD
Organization
Henry Ford Health System
ageorgi1@hfhs.org
313-916-7520

Study Officials

  • Michael Laker, M.D.

    Henry Ford Health System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2011

First Posted

June 10, 2011

Study Start

June 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

April 25, 2023

Results First Posted

July 9, 2013

Record last verified: 2023-03

Locations

US(1)