NCT07089251

Brief Summary

The aim of this clinical trial is to evaluate the effect of administering low-dose epinephrine and tranexamic acid on perioperative blood loss, thromboembolic complications, and hospitalization duration in patients undergoing knee joint arthroplasty. Also aim to evaluate the effect of administering low-dose epinephrine and tranexamic acid on perioperative thromboembolic complications, and hospitalization duration

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
14mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress42%
Jul 2025Jun 2027

First Submitted

Initial submission to the registry

July 9, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

July 15, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2027

Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

1.9 years

First QC Date

July 9, 2025

Last Update Submit

July 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Perioperative blood loss

    Calculated 24 h blood loss in mL, Hidden blood loss in mL, Hemoglobin levels in g/dL, Hematocrit levels as a percentage, Platelets count in cells/µL.

    Daily, till post-operative day 5

Secondary Outcomes (4)

  • Thromboembolic complications

    Daily, till post-operative day 5

  • Hospitalization duration

    Daily, till post-operative day 5

  • Drug side effects (epinephrine + tranexamic acid)

    Daily, till post-operative day 5

  • Complications

    Daily, till post-operative day 5

Study Arms (2)

Epinephrine + Tranexamic Acid Group

EXPERIMENTAL

The experimental group will receive both epinephrine and tranexamic acid

Drug: low-dose epinephrine and tranexamic acid

Tranexamic Acid Group

ACTIVE COMPARATOR

The comparator group will receive only tranexamic acid

Drug: Tranexamic Acid (TXA) treatment

Interventions

low-dose epinephrine and tranexamic acid

Epinephrine + Tranexamic Acid Group

Tranexamic Acid

Tranexamic Acid Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing knee joint arthroplasty.
  • Saudi and Non-Saudi Patient.
  • Patients who have Complete medical record.

You may not qualify if:

  • End stage renal disease
  • Liver cirrhosis
  • Coagulopathy
  • Pre-operative Hgb \<10 5.
  • History of cerebrovascular accident or myocardial infarction in past 12 months.
  • History of Heart failure.
  • History of arrhythmia.
  • History of pheochromocytoma, thyrotoxicosis and glaucoma.
  • Pregnancy or breast feeding
  • History of Deep venous thrombosis or pulmonary embolism
  • Allergy to epinephrine or tranexamic acid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdulaziz Medical City, Ministry of National Guard - Health Affairs

Riyadh, Riyadh Region, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

OsteoarthritisHemorrhage

Interventions

EpinephrineTranexamic AcidTherapeutics

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic Acids

Study Officials

  • Wazzan Aljuhani, MD, FRCSC, MBA, MMEd

    King Abdulaziz Medical City, MNGHA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Orthopedic Surgeon

Study Record Dates

First Submitted

July 9, 2025

First Posted

July 28, 2025

Study Start

July 15, 2025

Primary Completion (Estimated)

June 24, 2027

Study Completion (Estimated)

June 24, 2027

Last Updated

July 28, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Locations