Blood LossNCT02860221
Intravenous Versus Topical Administration of Low Dose Epinephrine Plus Combined Administration of Intravenous and Topical Tranexamic Acid (TXA)for Primary Total Knee Arthroplasty
A study testing Tranexamic acid (TXA) and Epinephrine in people with Blood Loss, run by Southwest Hospital, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Blood Loss
- What is being tested?
- Tranexamic acid (TXA) and Epinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- May 2015to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southwest Hospital
Chongqing, Chongqing Municipality, 400038
Weinan Zeng, doctor, +8615023100103, weinanzeng@163.com
About this study
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.
- Conditions
- Blood Loss
- Being tested
- Tranexamic acid (TXA), Epinephrine
- Keywords
- Arthroplasty, Replacement, Knee, Epinephrine, Tranexamic acid
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid (TXA)Drug
IV and topical administration
EpinephrineDrug
| Study group | Role | What they receive |
|---|---|---|
| Intravenous epinephrine | Experimental | Intravenous (IV) low dose epinephrine Receives: Drug: Tranexamic acid (TXA); Drug: Epinephrine |
| Topical epinephrine | Experimental | Topical epinephrine Receives: Drug: Tranexamic acid (TXA); Drug: Epinephrine |
| Control | Active comparator | No epinephrine Receives: Drug: Tranexamic acid (TXA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total blood loss on the post-operative day 1
Measured: 1 day post-operation
Secondary outcomes (27)
Haemoglobin (Hb)
g/L
Measured: 7 day
Hematocrit (Hct)
Percentage
Measured: 7 day
Blood platelet count (PLT)
Measured: 7 day
Post-operation Hospital for special surgery score (HSS)
Scoring
Measured: 3 months
Preoperative and post-operation range of motion (ROM) of operated knee joint (degree)
There is only one Unit of Measure for ROM, it is degree
Measured: Through study completion, an average of 3 months
Length of hospital stay (days)
Days
Measured: 3 months
Number of patients with infection
Post-operatively
Measured: 3 months
Number of deep vein thrombosis (DVT) cases
Post-operatively
Measured: 1 month
Number of pulmonary embolism (PE) cases
Post-operatively
Measured: 1 month
Intraoperative blood loss
Post-operatively
Measured: 3 hours
Intravenous fluid administration on the operation day
Milliliter
Measured: 1 day
Total blood loss on the post-operative day 3
Milliliter
Measured: 3 day post-operation
Reaction time (R-time)
Measured: 24 hours
Rate of thrombus formation (K time)
Measured: 24 hours
Maximum amplitude (MA)
Measured: 24 hours
Rate of thrombus formation (α-angle)
Measured: 24 hours
Lysis rate at 30 min (LY30)
Measured: 24 hours
Coagulation index (CI)
Measured: 24 hours
Interleukin(IL)-1β
Measured: 24 hours
Interleukin(IL)-6
Measured: 24 hours
Interleukin(IL)-8
Measured: 24 hours
Tumor necrosis factor (TNF)-α
Measured: 24 hours
C-reactive protein (CRP)
Measured: 24 hours
Interleukin(IL)-10
Measured: 24 hours
Wound score
Measured: 14 day
Blood transfusion rate
Measured: 7 day
Blood transfusion volume (mL)
Measured: 7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startMay 2015
- Primary completionJul 2017 (estimated)
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood LossStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Yang, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860221
- Sponsor's protocol ID
- Knee blood
- Status last verified
- Jul 2017
- First submitted
- 28 Jul 2016
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Versus Topical Administration of Low Dose Epinephrine Plus Combined Administration of Intravenous and Topical Tranexamic Acid (TXA)for Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02860221
- Acronym / sponsor ID
- Knee blood
- Conditions
- Blood Loss
- Keywords
- Arthroplasty, Replacement, Knee, Epinephrine, Tranexamic acid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017
- First posted
- 9 Aug 2016 (estimated)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intravenous epinephrine | Experimental | Drug: Tranexamic acid (TXA), Drug: EpinephrineIntravenous (IV) low dose epinephrine |
| Topical epinephrine | Experimental | Drug: Tranexamic acid (TXA), Drug: EpinephrineTopical epinephrine |
| Control | Active comparator | Drug: Tranexamic acid (TXA)No epinephrine |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
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 |
|---|---|---|
| Tranexamic acid (TXA)IV and topical administration | Drug | Control, Intravenous epinephrine, Topical epinephrine |
| Epinephrine | Drug | Intravenous epinephrine, Topical epinephrine |
Primary outcome
Total blood loss on the post-operative day 1
Time frame: 1 day post-operation
27 secondary outcomes
Haemoglobin (Hb)
Time frame: 7 day
Hematocrit (Hct)
Time frame: 7 day
Blood platelet count (PLT)
Time frame: 7 day
Post-operation Hospital for special surgery score (HSS)
Time frame: 3 months
Preoperative and post-operation range of motion (ROM) of operated knee joint (degree)
Time frame: Through study completion, an average of 3 months
Length of hospital stay (days)
Time frame: 3 months
Number of patients with infection
Time frame: 3 months
Number of deep vein thrombosis (DVT) cases
Time frame: 1 month
Number of pulmonary embolism (PE) cases
Time frame: 1 month
Intraoperative blood loss
Time frame: 3 hours
Intravenous fluid administration on the operation day
Time frame: 1 day
Total blood loss on the post-operative day 3
Time frame: 3 day post-operation
Reaction time (R-time)
Time frame: 24 hours
Rate of thrombus formation (K time)
Time frame: 24 hours
Maximum amplitude (MA)
Time frame: 24 hours
Rate of thrombus formation (α-angle)
Time frame: 24 hours
Lysis rate at 30 min (LY30)
Time frame: 24 hours
Coagulation index (CI)
Time frame: 24 hours
Interleukin(IL)-1β
Time frame: 24 hours
Interleukin(IL)-6
Time frame: 24 hours
Interleukin(IL)-8
Time frame: 24 hours
Tumor necrosis factor (TNF)-α
Time frame: 24 hours
C-reactive protein (CRP)
Time frame: 24 hours
Interleukin(IL)-10
Time frame: 24 hours
Wound score
Time frame: 14 day
Blood transfusion rate
Time frame: 7 day
Blood transfusion volume (mL)
Time frame: 7 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic acid (TXA) and Epinephrine in people with Blood Loss, run by Southwest Hospital, China at 1 site in China.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 27 Jul 2017. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total blood loss on the post-operative day 1 (time frame: 1 day post-operation). 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 27 Jul 2017.