NCT02860221

Brief Summary

The purpose of this study is to compare the blood loss of intravenous and topical administration of low dose epinephrine plus combined administration of intravenous and topical tranexamic acid for primary total knee arthroplasty.

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
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

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

Study Start

First participant enrolled

May 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 27, 2017

Status Verified

July 1, 2017

Enrollment Period

2.2 years

First QC Date

July 28, 2016

Last Update Submit

July 25, 2017

Conditions

Blood Loss

Keywords

Arthroplasty, Replacement, KneeEpinephrineTranexamic acid

Outcome Measures

Primary Outcomes (1)

  • Total blood loss on the post-operative day 1

    1 day post-operation

Secondary Outcomes (27)

  • Haemoglobin (Hb)

    7 day

  • Hematocrit (Hct)

    7 day

  • Blood platelet count (PLT)

    7 day

  • Post-operation Hospital for special surgery score (HSS)

    3 months

  • Preoperative and post-operation range of motion (ROM) of operated knee joint (degree)

    Through study completion, an average of 3 months

  • +22 more secondary outcomes

Study Arms (3)

Intravenous epinephrine

EXPERIMENTAL

Intravenous (IV) low dose epinephrine

Drug: Tranexamic acid (TXA)Drug: Epinephrine

Topical epinephrine

EXPERIMENTAL

Topical epinephrine

Drug: Tranexamic acid (TXA)Drug: Epinephrine

Control

ACTIVE COMPARATOR

No epinephrine

Drug: Tranexamic acid (TXA)

Interventions

Tranexamic acid (TXA)DRUG

IV and topical administration

ControlIntravenous epinephrineTopical epinephrine
EpinephrineDRUG
Intravenous epinephrineTopical epinephrine

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients between the ages of 20 and 75 who were diagnosed with osteoarthritis of the knee and scheduled for an elective primary total knee arthroplasty and those who were willing and able to return for follow-up over at least a 6-month postoperative period

You may not qualify if:

  • Acute coronary syndrome \< 6 months
  • Glaucoma,pheochromocytoma, thyrotoxicosis, digoxin intoxication, serum potassium \< 3.0 mmol, alcohol abuse, premenopausal women
  • Current treatment with adenosine diphosphate (ADP) receptor antagonists, Factor Xa or thrombin inhibitors,heparin (excluding Low Molecular Weight Heparin (LMWH) for perioperative thromboprophylaxis), tricyclic antidepressants, or monoamine oxidase（MAO) or Catechol-O-methyltransferase (COMT) inhibitors
  • Patients with history of thromboembolic disease, bleeding disorder
  • Patients with history of renal impairment, cardiovascular diseases (previous myocardial infarction, atrial fibrillation) or cerebrovascular conditions (previous stroke or peripheral vascular surgery)
  • Allergy to TXA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic AcidEpinephrine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsEthanolaminesAmino AlcoholsAlcoholsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

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

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 9, 2016

Study Start

May 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

July 27, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)