Knee Arthroplasty, TotalPhase 4NCT07089251
The Perioperative Outcome of Epinephrine Infusion and Tranexamic Acid in Knee Arthroplasty Surgery
A Phase 4 study testing low-dose epinephrine and tranexamic acid and Tranexamic Acid (TXA) treatment in people with Knee Arthroplasty, Total and Knee Arthritis, Osteoarthritis, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Knee Arthroplasty, Total, Knee Arthritis, Osteoarthritis, Total Knee Anthroplasty
- What is being tested?
- low-dose epinephrine and tranexamic acid and Tranexamic Acid (TXA) treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Jul 2025to 24 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing knee joint arthroplasty.
- Saudi and Non-Saudi Patient.
- Patients who have Complete medical record.
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Abdulaziz Medical City, Ministry of National Guard - Health Affairs
Riyadh, Riyadh Region
About this study
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
Read the detailed description
Patients will be randomly divided into two groups: one receiving intravenous low-dose epinephrine and tranexamic acid, while the other will receive TXA alone as the control. Randomization to be done using a computer-generated table.
The study will be done a superiority clinical trial. with an estimated 24 hour blood loss of 300 ml, with standard deviation of 150 ml. a power of 80% and alpha 5%, an estimated sample size of 80 is needed to detect a difference.
- Conditions
- Knee Arthroplasty, Total, Knee Arthritis, Osteoarthritis, Total Knee Anthroplasty, Blood Loss, Tranexamic Acid Use, Epinephrine
- Being tested
- low-dose epinephrine and tranexamic acid, Tranexamic Acid (TXA) treatment
- Medical subject headings
- Osteoarthritis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-dose epinephrine and tranexamic acidDrug
low-dose epinephrine and tranexamic acid
Tranexamic Acid (TXA) treatmentDrug
Tranexamic Acid
| Study group | Role | What they receive |
|---|---|---|
| Epinephrine + Tranexamic Acid Group | Experimental | The experimental group will receive both epinephrine and tranexamic acid Receives: Drug: low-dose epinephrine and tranexamic acid |
| Tranexamic Acid Group | Active comparator | The comparator group will receive only tranexamic acid Receives: Drug: Tranexamic Acid (TXA) treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Daily, till post-operative day 5
Secondary outcomes (4)
Thromboembolic complications
Measured: Daily, till post-operative day 5
Hospitalization duration
Measured: Daily, till post-operative day 5
Drug side effects (epinephrine + tranexamic acid)
Measured: Daily, till post-operative day 5
Complications
VTE, SSI, UTI, AKI, Cardiac Arrhythmias, Stroke
Measured: Daily, till post-operative day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start15 Jul 2025
- Primary completion24 Jun 2027 (estimated)
- Study completion24 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthroplasty, TotalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wazzan Saleh ALJuhani, King Abdullah International Medical Research Center
- Investigators
- Wazzan Aljuhani, MD, FRCSC, MBA, MMEd, Principal investigator, King Abdulaziz Medical City, MNGHA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089251
- Sponsor's protocol ID
- ICTR24/002/9
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Perioperative Outcome of Epinephrine Infusion and Tranexamic Acid in Knee Arthroplasty Surgery
- ClinicalTrials.gov ID
- NCT07089251
- Acronym / sponsor ID
- ICTR24/002/9
- Conditions
- Knee Arthroplasty, Total, Knee Arthritis, Osteoarthritis, Total Knee Anthroplasty, Blood Loss, Tranexamic Acid Use, Epinephrine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 24 Jun 2027 (estimated)
- Study completion
- 24 Jun 2027 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Patients will be randomly divided into two groups: one receiving intravenous low-dose epinephrine and tranexamic acid, while the other will receive TXA alone as the control. Randomization to be done using a computer-generated table.
The study will be done a superiority clinical trial. with an estimated 24 hour blood loss of 300 ml, with standard deviation of 150 ml. a power of 80% and alpha 5%, an estimated sample size of 80 is needed to detect a difference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epinephrine + Tranexamic Acid Group | Experimental | Drug: low-dose epinephrine and tranexamic acidThe experimental group will receive both epinephrine and tranexamic acid |
| Tranexamic Acid Group | Active comparator | Drug: Tranexamic Acid (TXA) treatmentThe comparator group will receive only tranexamic acid |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing knee joint arthroplasty.
- Saudi and Non-Saudi Patient.
- Patients who have Complete medical record.
Key exclusion criteria (11 listed)
- End stage renal disease
- Liver cirrhosis
- Coagulopathy
- Pre-operative Hgb <10 5.
- History of cerebrovascular accident or myocardial infarction in past 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-dose epinephrine and tranexamic acidlow-dose epinephrine and tranexamic acid | Drug | Epinephrine + Tranexamic Acid Group |
| Tranexamic Acid (TXA) treatmentTranexamic Acid | Drug | Tranexamic Acid Group |
Primary outcome
Perioperative blood loss
Time frame: Daily, till post-operative day 5
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.
4 secondary outcomes
Thromboembolic complications
Time frame: Daily, till post-operative day 5
Hospitalization duration
Time frame: Daily, till post-operative day 5
Drug side effects (epinephrine + tranexamic acid)
Time frame: Daily, till post-operative day 5
Complications
Time frame: Daily, till post-operative day 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wazzan Aljuhani, MD, FRCSC, MBA, MMEd principal investigator
King Abdulaziz Medical City, MNGHA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing low-dose epinephrine and tranexamic acid and Tranexamic Acid (TXA) treatment in people with Knee Arthroplasty, Total and Knee Arthritis, Osteoarthritis, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Turki Althunayan (+966 55 994 4782, althunayan.tu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative blood loss (time frame: Daily, till post-operative day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.