NCT01683955

Brief Summary

This study aims to assess postoperative blood loss and transfusion rates in total hip 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
139

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2013

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

September 8, 2012

Last Update Submit

March 30, 2023

Conditions

Acute Blood Loss AnemiaOsteoarthritis, Hip

Keywords

Tranexamic AcidBlood transfusionTotal hip arthroplasty

Outcome Measures

Primary Outcomes (1)

  • postoperative blood loss

    Preoperative and lowest postoperative hemoglobin

    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 hip arthroplasty.

Drug: Tranexamic acid

Placebo

PLACEBO COMPARATOR

100mL 0.9% sterile saline, applied topically

Drug: Placebo

Interventions

Tranexamic acidDRUG

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

Also known as: cyclokapron
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 hip 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 (2)

Henry Ford Hospital

Detroit, Michigan, 48067, United States

Location

HFH Main campus

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Michael Laker, M.D.

    Henry Ford Health Systems

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
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

September 8, 2012

First Posted

September 12, 2012

Study Start

January 1, 2013

Primary Completion

November 3, 2013

Study Completion

November 3, 2013

Last Updated

April 3, 2023

Record last verified: 2023-03

Locations

US(2)