Total Knee ArthroplastyPhase 2NCT02922582

Study of Local Administration of DepoTXA for Reduced Postsurgical Bleeding in Subjects Undergoing TKA

A Phase 2 study testing DepoTXA and Tranexamic Acid in people with Total Knee Arthroplasty, run by Pacira Pharmaceuticals, Inc at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a Phase 2, randomized, single-blind, active-controlled dose-ranging study in subjects scheduled to undergo total knee arthroplasty (TKA). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Total Knee Arthroplasty
What is being tested?: DepoTXA and Tranexamic Acid
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 5 sitesUnited States
Study dates: 28 Oct 2016to 27 Nov 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, ≥18 years of age at screening.
Scheduled to undergo elective unilateral open TKA under general, spinal, or regional anesthesia.
American Society of Anesthesiology (ASA) physical status 1, 2, or 3.
Female subject must be surgically sterile; or at least 2 years postmenopausal; or have a monogamous partner who is surgically sterile; or practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, or transdermal, contraceptive approved by the FDA for greater than 2 months prior to screening and commit to the use of an acceptable form of birth control for the duration of the study and for 30 days after completion of the study.
Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.

Who cannot join

Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
Planned concurrent surgical procedure (e.g., bilateral TKA).
Prior open knee surgery on ipsilateral knee. Prior arthroscopy is permitted.
Subjects taking a medication with a known procoagulant effect (e.g., combination hormonal contraceptives, Factor IX complex concentrates or anti-inhibitor coagulant concentrates, or all-trans retinoic acid).
Contraindication or hypersensitivity to TXA.
History of thrombosis or prior Venous thromboembolism (VTE).

Show all 20Show fewer

Known coagulopathy or active intravascular clotting.
Prior myocardial infarction.
Prior cardiovascular accident (stroke) or subarachnoid hemorrhage.
History of epilepsy.
Presence of an intravascular stent.
History of impaired kidney function, chronic respiratory disease, rheumatoid arthritis, coagulopathy, or loss of sensation in extremities.
Renal insufficiency (serum creatinine level >2 mg/dL).
Anemia (Hb level <10 g/dL).
Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments.
Acquired defective color vision.
Malignancy in the last 2 years, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
Suspected or known history of drug or alcohol abuse within the previous year.
Body weight <50 kg (110 pounds) or a body mass index >44 kg/m2.
Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Medical University of South Carolina
Charleston, South Carolina, 29425
Ohio State University/Wexner Medical Center
Columbus, Ohio, 43210
Ortho Arizona
Gilbert, Arizona, 85296
University of Miami Hospital
Miami, Florida, 33136
Kendall Regional Medical Center
Miami, Florida, 33175

Other trials in United States

About this study

Official title: A Randomized, Single-Blind, Active-Controlled, Dose-Ranging Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Local Administration of DepoTXA for Reduced Postsurgical Bleeding in Subjects Undergoing Total Knee Arthroplasty

This is a Phase 2, randomized, single-blind, active-controlled dose-ranging study in subjects scheduled to undergo total knee arthroplasty (TKA).

Read the detailed description

Approximately 60 subjects (15 per arm) are planned for enrollment. Subjects will be randomized in a 1:1:1:1 ratio to receive either DepoTXA 400 mg, DepoTXA 800 mg, DepoTXA 1200 mg, or IV TXA (Cyklokapron® 1 gram).

Conditions: Total Knee Arthroplasty
Being tested: DepoTXA, Tranexamic Acid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DepoTXADrug
Tranexamic AcidDrug

Study groups in NCT02922582
Study group	Role	What they receive
DepoTXA 400mg	Experimental	400mg Intracapsular at the end of surgery one time Receives: Drug: DepoTXA
DepoTXA 800mg	Experimental	800mg Intracapsular at the end of surgery one time Receives: Drug: DepoTXA
DepoTXA 1200mg	Experimental	1200mg Intracapsular at the end of surgery one time Receives: Drug: DepoTXA
IV Tranexamic acid (TXA)	Active comparator	1 g of IV TXA at the end of surgery Receives: Drug: Tranexamic Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Plasma Concentration-versus-time Curve From Time 0 Extrapolated to Infinity After Drug Administration
Measured: Baseline; 5, 15, and 30 min; at 1, 2, 4, 6, 8, 12, 16, and 24 hours after study drug administration for all treatment groups. Additional blood samples were collected at 36, 48, 60, 72, and 96 hours for DepoTXA-treated subjects.
Area Under the Plasma Concentration-versus-time Curve From Time 0 to the Last Collection Time After Drug Administration
Measured: Baseline; 5, 15, and 30 min; at 1, 2, 4, 6, 8, 12, 16, and 24 hours after study drug administration for all treatment groups. Additional blood samples were collected at 36, 48, 60, 72, and 96 hours for DepoTXA-treated subjects.
Maximum Plasma Concentration (Cmax)
Measured: Baseline; 5, 15, and 30 min; at 1, 2, 4, 6, 8, 12, 16, and 24 hours after study drug administration for all treatment groups. Additional blood samples were collected at 36, 48, 60, 72, and 96 hours for DepoTXA-treated subjects.
Time to Maximum Plasma Concentration (Tmax)
Measured: Baseline; 5, 15, and 30 min; at 1, 2, 4, 6, 8, 12, 16, and 24 hours after study drug administration for all treatment groups. Additional blood samples were collected at 36, 48, 60, 72, and 96 hours for DepoTXA-treated subjects.
The Apparent Terminal Elimination Rate Constant
Measured: Baseline; 5, 15, and 30 min; at 1, 2, 4, 6, 8, 12, 16, and 24 hours after study drug administration for all treatment groups. Additional blood samples were collected at 36, 48, 60, 72, and 96 hours for DepoTXA-treated subjects.
The Apparent Terminal Elimination Half-life
Measured: Baseline; 5, 15, and 30 min; at 1, 2, 4, 6, 8, 12, 16, and 24 hours after study drug administration for all treatment groups. Additional blood samples were collected at 36, 48, 60, 72, and 96 hours for DepoTXA-treated subjects.

Secondary outcomes (7)

Summary of Neurological Assessments (Proportion of Subjects Who Were Oriented and Proportion of Subjects Who Had Any of the Neurologic Events) at Each Assessed Timepoint
Neurological assessment at 12, 24, 36, 48, 60, 72, and 96 hours after study drug administration
Measured: 12, 24, 36, 48, 60, 72, and 96 hours after study drug administration
Incidence of Reoperation Due to Hematoma or Wound Dehiscence
Number of subjects who underwent reoperation due to hematoma or wound dehiscence
Measured: Through day 60
Incidence of Transfusion (Number of Units, Number of Units/Subject, Number of Subjects Transfused)
Measured: Day 60
Number of Participants With 90˚ Passive and Active Knee Flexion
Measured: 24, 48, and 72 hours
Time to Complete Timed Up-and-Go (TUG) Test
Physical therapy assessment (Timed Up-and-Go (TUG) test) was conducted once postsurgically on Day 1; at approximately 8:00 am and 8:00 pm (±2 hours) daily from Day 2 through hospital discharge; and on Day 7
Measured: Day 1; at approximately 8:00 am and 8:00 pm (±2 hours) daily from Day 2 through hospital discharge; and on Day 7
Change in Knee and Thigh Measurements
Leg difference in change from baseline is calculated by = (Operated Leg Change from Baseline) - (Non-Operated Leg Change from Baseline)
Measured: 48 hours and Day 7
Area Under the Curve (AUC) of NRS From 0-24 Hours, 0-48 Hours, and 24-48 Hours
Numerical rating scale (NRS) at rest pain score (0 [no pain] to 10 [worst possible pain]) upon arrival at the PACU; at each in-hospital vital sign assessment beginning with the 2-hour assessment and ending with the 48-hour assessment; and the Day-7 follow-up visit. Summary is provided as area under the curve (AUC) of NRS from timepoint 0 to 24 hours, 0 to 48 hours, and 24 to 48 hours.
Measured: Preoperative; arrival in Post-Anesthesia Care Unit (PACU); 2, 4, 6, 8, 12, 16, 24, 36, 48 hours, Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Oct 201627 Nov 2017

First posted4 Oct 2016 (estimated)
Study start28 Oct 2016
Primary completion27 Nov 2017
Study completion27 Nov 2017

Why it stopped: Slow Enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Total Knee ArthroplastyStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02922582
Sponsor's protocol ID: 404-C-201
Status last verified: Dec 2020
First submitted: 28 Sep 2016
Last updated: 11 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)

All Total Knee Arthroplasty trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Single-Blind, Active-Controlled, Dose-Ranging Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Local Administration of DepoTXA for Reduced Postsurgical Bleeding in Subjects Undergoing Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT02922582
Acronym / sponsor ID: 404-C-201
Conditions: Total Knee Arthroplasty
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow Enrollment
Enrolment: 16 participants (actual)
Lead sponsor: Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
Study start: 28 Oct 2016 (actual)
Primary completion: 27 Nov 2017 (actual)
Study completion: 27 Nov 2017 (actual)
First posted: 4 Oct 2016 (estimated)
Results: Posted 11 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a Phase 2, randomized, single-blind, active-controlled dose-ranging study in subjects scheduled to undergo total knee arthroplasty (TKA).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
DepoTXA 400mg	Experimental	Drug: DepoTXA400mg Intracapsular at the end of surgery one time
DepoTXA 800mg	Experimental	Drug: DepoTXA800mg Intracapsular at the end of surgery one time
DepoTXA 1200mg	Experimental	Drug: DepoTXA1200mg Intracapsular at the end of surgery one time
IV Tranexamic acid (TXA)	Active comparator	Drug: Tranexamic Acid1 g of IV TXA at the end of surgery

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male or female, ≥18 years of age at screening.
Scheduled to undergo elective unilateral open TKA under general, spinal, or regional anesthesia.
American Society of Anesthesiology (ASA) physical status 1, 2, or 3.
Female subject must be surgically sterile; or at least 2 years postmenopausal; or have a monogamous partner who is surgically sterile; or practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, or transdermal, contraceptive approved by the FDA for greater than 2 months prior to screening and commit to the use of an acceptable form of birth control for the duration of the study and for 30 days after completion of the study.
Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.

Key exclusion criteria (20 listed)

Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
Planned concurrent surgical procedure (e.g., bilateral TKA).
Prior open knee surgery on ipsilateral knee. Prior arthroscopy is permitted.
Subjects taking a medication with a known procoagulant effect (e.g., combination hormonal contraceptives, Factor IX complex concentrates or anti-inhibitor coagulant concentrates, or all-trans retinoic acid).
Contraindication or hypersensitivity to TXA.

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
DepoTXA	Drug	DepoTXA 1200mg, DepoTXA 400mg, DepoTXA 800mg
Tranexamic Acid	Drug	IV Tranexamic acid (TXA)

Primary outcome

Area Under the Plasma Concentration-versus-time Curve From Time 0 Extrapolated to Infinity After Drug Administration
Time frame: Baseline; 5, 15, and 30 min; at 1, 2, 4, 6, 8, 12, 16, and 24 hours after study drug administration for all treatment groups. Additional blood samples were collected at 36, 48, 60, 72, and 96 hours for DepoTXA-treated subjects.
Area Under the Plasma Concentration-versus-time Curve From Time 0 to the Last Collection Time After Drug Administration
Time frame: Baseline; 5, 15, and 30 min; at 1, 2, 4, 6, 8, 12, 16, and 24 hours after study drug administration for all treatment groups. Additional blood samples were collected at 36, 48, 60, 72, and 96 hours for DepoTXA-treated subjects.
Maximum Plasma Concentration (Cmax)
Time frame: Baseline; 5, 15, and 30 min; at 1, 2, 4, 6, 8, 12, 16, and 24 hours after study drug administration for all treatment groups. Additional blood samples were collected at 36, 48, 60, 72, and 96 hours for DepoTXA-treated subjects.
Time to Maximum Plasma Concentration (Tmax)
Time frame: Baseline; 5, 15, and 30 min; at 1, 2, 4, 6, 8, 12, 16, and 24 hours after study drug administration for all treatment groups. Additional blood samples were collected at 36, 48, 60, 72, and 96 hours for DepoTXA-treated subjects.
The Apparent Terminal Elimination Rate Constant
Time frame: Baseline; 5, 15, and 30 min; at 1, 2, 4, 6, 8, 12, 16, and 24 hours after study drug administration for all treatment groups. Additional blood samples were collected at 36, 48, 60, 72, and 96 hours for DepoTXA-treated subjects.
The Apparent Terminal Elimination Half-life
Time frame: Baseline; 5, 15, and 30 min; at 1, 2, 4, 6, 8, 12, 16, and 24 hours after study drug administration for all treatment groups. Additional blood samples were collected at 36, 48, 60, 72, and 96 hours for DepoTXA-treated subjects.

7 secondary outcomes

Summary of Neurological Assessments (Proportion of Subjects Who Were Oriented and Proportion of Subjects Who Had Any of the Neurologic Events) at Each Assessed Timepoint
Time frame: 12, 24, 36, 48, 60, 72, and 96 hours after study drug administration
Incidence of Reoperation Due to Hematoma or Wound Dehiscence
Time frame: Through day 60
Incidence of Transfusion (Number of Units, Number of Units/Subject, Number of Subjects Transfused)
Time frame: Day 60
Number of Participants With 90˚ Passive and Active Knee Flexion
Time frame: 24, 48, and 72 hours
Time to Complete Timed Up-and-Go (TUG) Test
Time frame: Day 1; at approximately 8:00 am and 8:00 pm (±2 hours) daily from Day 2 through hospital discharge; and on Day 7
Change in Knee and Thigh Measurements
Time frame: 48 hours and Day 7
Area Under the Curve (AUC) of NRS From 0-24 Hours, 0-48 Hours, and 24-48 Hours
Time frame: Preoperative; arrival in Post-Anesthesia Care Unit (PACU); 2, 4, 6, 8, 12, 16, 24, 36, 48 hours, Day 7

Results and safety

Results posted to the registry on 11 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DepoTXA 400mg	4	4
DepoTXA 800mg	4	3
DepoTXA 1200mg	4	4
IV Tranexamic Acid (TXA)	4	4

Primary outcome: Area Under the Plasma Concentration-versus-time Curve From Time 0 Extrapolated to Infinity After Drug Administration

Time frame: Baseline; 5, 15, and 30 min; at 1, 2, 4, 6, 8, 12, 16, and 24 hours after study drug administration for all treatment groups. Additional blood samples were collected at 36, 48, 60, 72, and 96 hours for DepoTXA-treated subjects.. Mean (Standard Deviation). Unit: hr*ng/mL

Measure	DepoTXA 400mg n = 4	DepoTXA 800mg n = 2	DepoTXA 1200mg n = 4	IV Tranexamic Acid (TXA) n = 4
Value	46462.15 (6935.828)	106422.7 (42128.84)	148806.2 (14137.74)	134602.2 (29975.88)

Population analysed: Pharmacokinetic (PK) analysis set: All subjects who received study drug, provided sufficient samples to allow for calculation of PK parameters required for analysis, and who did not have significant protocol deviations

Primary outcome: Area Under the Plasma Concentration-versus-time Curve From Time 0 to the Last Collection Time After Drug Administration

Measure	DepoTXA 400mg n = 4	DepoTXA 800mg n = 2	DepoTXA 1200mg n = 4	IV Tranexamic Acid (TXA) n = 4
Value	43784.71 (6463.220)	104546.5 (42813.20)	143562.9 (13931.94)	131153.0 (27286.97)

Primary outcome: Maximum Plasma Concentration (Cmax)

Measure	DepoTXA 400mg n = 4	DepoTXA 800mg n = 2	DepoTXA 1200mg n = 4	IV Tranexamic Acid (TXA) n = 4
Value	2775.0 (741.96)	7722.0 (2015.25)	9827.0 (1545.83)	125390.0 (154587.6)

Primary outcome: Time to Maximum Plasma Concentration (Tmax)

Measure	DepoTXA 400mg n = 4	DepoTXA 800mg n = 2	DepoTXA 1200mg n = 4	IV Tranexamic Acid (TXA) n = 4
Value	1.6 (0.55)	1.5 (0.57)	2.5 (0.96)	0.1 (0)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From screening to postsurgical day 60. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DepoTXA 400mg	0 of 4 (0%)	4 of 4 (100%)	0 of 4
DepoTXA 800mg	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
DepoTXA 1200mg	0 of 4 (0%)	4 of 4 (100%)	0 of 4
IV Tranexamic Acid (TXA)	0 of 4 (0%)	4 of 4 (100%)	0 of 4

Limitations and caveats (from the sponsor): This study was terminated on 27-Nov-2017 due to low enrollment; small sample sizes make data interpretation difficult.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Total Knee Arthroplasty

RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
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Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
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RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
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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.

Hassan Danesi, MD study director

Pacira Pharmaceuticals, Inc

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DepoTXA and Tranexamic Acid in people with Total Knee Arthroplasty, run by Pacira Pharmaceuticals, Inc at 5 sites in United States.

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 5 inclusion and 20 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: stopped early, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Plasma Concentration-versus-time Curve From Time 0 Extrapolated to Infinity After Drug Administration (time frame: Baseline; 5, 15, and 30 min; at 1, 2, 4, 6, 8, 12, 16, and 24 hours after study drug administration for all treatment groups. Additional blood samples were collected at 36, 48, 60, 72, and 96 hours for DepoTXA-treated subjects.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02922582.

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 11 Dec 2020.