Blood LossPhase 4NCT02427412
Evaluation of Intraarticular Tranexamic Acid to Reduction of Total Blood Loss Following Knee-Arthroplasty
A Phase 4 study testing Tranexamic Acid and Saline water in people with Blood Loss and Postoperative Blood Loss, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
A randomized, prospective, placebo-controlled study which aims to evaluate the effect of combined intraarticular and intravenous Tranexamic acid on total blood loss following unilateral knee replacement versus only intravenous tranexamic acid. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Loss, Postoperative Blood Loss, Thromboembolic Complications
- What is being tested?
- Tranexamic Acid and Saline water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2014to May 2015
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years old
- Unilateral knee replacement
- Must be able to give oral and written consent
Who cannot join
- General Anesthetized
- Allergic to Tranexamic acid
- In treatment with the following anticoagulants: Adenosine diphosphate receptor inhibitors or vitamin K antagonist within in the last 5 days. Factor Xa inhibitor and thrombin inhibitor.
- Use of oral anticonceptive.
- Reduced kidney function (S-creatinine > 120 micromol/L)
- Medicine or alcohol abuse
Show all 10Show fewer
- Females with menstruation within the last 12 mounts.
- Any kind of cancer disease
- Rheumatoid arthritis
- Have participated in a clinical trial within the last 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Intraarticular Tranexamic Acid to Reduction of Total Blood Loss Following Knee-Arthroplasty - A Randomized, Prospective, Placebo-Controlled Study
A randomized, prospective, placebo-controlled study which aims to evaluate the effect of combined intraarticular and intravenous Tranexamic acid on total blood loss following unilateral knee replacement versus only intravenous tranexamic acid.
Read the detailed description
Intravenous (IV) Tranexamic acid is already well-established and well-documented regarding significant effect on reducing blood loss following knee replacement. A few studies more shown a similar effect of intraarticular (IA) injected Tranexamic acid into the knee joint at the end of surgery for knee replacement.
In this study investigators therefore investigate the possible combined effect of added intraarticular tranexamic acid to conventional intravenous Tranexamic acid.
- Being tested
- Tranexamic Acid, Saline water
- Keywords
- Tranexamic Acid, Knee Arthroplasty, Blood loss, Blood transfusion, Thrombolic complication, Total blood loss 24 h after ended surgery., Total blood loss 2 days after ended surgery.
- Medical subject headings
- Hemorrhage, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called Cyclokapron
An anti-fibrinolytic drug injected into the knee joint at the end of surgery, 3 g diluted in 30 ml saline water.
Saline waterDrug
Also called NaCl water
30 ml of Saline water injected into the knee capsula at the end of surgery.
Tranexamic AcidDrug
Also called Cyklocapron
An anti-fibrinolytic drug injected intravenous at the beginning of surgery for BOTH groups.
| Study group | Role | What they receive |
|---|---|---|
| IA Tranexamic acid + IV Tranexamic Acid | Active comparator | 3 gram of Tranexamic acid diluted into 30 ml Saline Water injected into the knee capsula after ended surgery + 1 g of Tranexamic acid injected intravenous at the start of surgery. Receives: Drug: Tranexamic Acid |
| IA Saline Water + IV tranexamic Acid | Placebo comparator | 30 ml Saline Water injected into the knee capsula after ended surgery + 1 g of Tranexamic acid injected intravenous at the start of surgery. Receives: Drug: Saline water; Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total estimated blood loss
Measured: 24 hours surgery
Secondary outcomes (3)
Total estimated blood loss
Measured: 2 days after surgery
Thromboembolic complications
90 days followup for thromboembolic complications.
Measured: 90 days postoperative
Blood transfusion
Estimate the extent of blood transfusions during admission and readmission in relation to the knee replacement
Measured: while hospitalized expected 3 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startJan 2014
- Primary completionMay 2015
- Study completionMay 2015
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Skovgaard Nielsen, Hvidovre University Hospital
- Investigators
- Henrik Husted, PhD, Study director, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427412
- Sponsor's protocol ID
- H-3-2013-134
- Status last verified
- May 2015
- First submitted
- 20 Apr 2015
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intraarticular Tranexamic Acid to Reduction of Total Blood Loss Following Knee-Arthroplasty - A Randomized, Prospective, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT02427412
- Acronym / sponsor ID
- H-3-2013-134
- Keywords
- Tranexamic Acid, Knee Arthroplasty, Blood loss, Blood transfusion, Thrombolic complication, Total blood loss 24 h after ended surgery., Total blood loss 2 days after ended surgery.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 28 Apr 2015 (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.
A randomized, prospective, placebo-controlled study which aims to evaluate the effect of combined intraarticular and intravenous Tranexamic acid on total blood loss following unilateral knee replacement versus only intravenous tranexamic acid.
Detailed description
Intravenous (IV) Tranexamic acid is already well-established and well-documented regarding significant effect on reducing blood loss following knee replacement. A few studies more shown a similar effect of intraarticular (IA) injected Tranexamic acid into the knee joint at the end of surgery for knee replacement.
In this study investigators therefore investigate the possible combined effect of added intraarticular tranexamic acid to conventional intravenous Tranexamic acid.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IA Tranexamic acid + IV Tranexamic Acid | Active comparator | Drug: Tranexamic Acid3 gram of Tranexamic acid diluted into 30 ml Saline Water injected into the knee capsula after ended surgery + 1 g of Tranexamic acid injected intravenous at the start of surgery. |
| IA Saline Water + IV tranexamic Acid | Placebo comparator | Drug: Saline water, Drug: Tranexamic Acid30 ml Saline Water injected into the knee capsula after ended surgery + 1 g of Tranexamic acid injected intravenous at the start of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > 18 years old
- Unilateral knee replacement
- Must be able to give oral and written consent
Key exclusion criteria (10 listed)
- General Anesthetized
- Allergic to Tranexamic acid
- In treatment with the following anticoagulants: Adenosine diphosphate receptor inhibitors or vitamin K antagonist within in the last 5 days. Factor Xa inhibitor and thrombin inhibitor.
- Use of oral anticonceptive.
- Reduced kidney function (S-creatinine > 120 micromol/L)
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 AcidAlso: CyclokapronAn anti-fibrinolytic drug injected into the knee joint at the end of surgery, 3 g diluted in 30 ml saline water. | Drug | IA Tranexamic acid + IV Tranexamic Acid |
| Saline waterAlso: NaCl water30 ml of Saline water injected into the knee capsula at the end of surgery. | Drug | IA Saline Water + IV tranexamic Acid |
| Tranexamic AcidAlso: CyklocapronAn anti-fibrinolytic drug injected intravenous at the beginning of surgery for BOTH groups. | Drug | IA Saline Water + IV tranexamic Acid, IA Tranexamic acid + IV Tranexamic Acid |
Primary outcome
Total estimated blood loss
Time frame: 24 hours surgery
3 secondary outcomes
Total estimated blood loss
Time frame: 2 days after surgery
Thromboembolic complications
Time frame: 90 days postoperative
Blood transfusion
Time frame: while hospitalized expected 3 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
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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.
Henrik Husted, PhD study director
Hvidovre University Hospital
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 Tranexamic Acid and Saline water in people with Blood Loss and Postoperative Blood Loss, run by Hvidovre University Hospital at 1 site in Denmark.
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 10 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: finished, as of the sponsor's last update on 17 Aug 2015. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total estimated blood loss (time frame: 24 hours surgery). 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 17 Aug 2015.