Total Hip ArthroplastyPhase 4NCT01622946
The Effect of Topical Application of Tranexamic Acid in Total Hip Arthroplasty Through the Direct Anterior Approach
A Phase 4 study testing Tranexamic Acid in people with Total Hip Arthroplasty and Postoperative Blood Loss, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The effects of topical application of 3g tranexamic acid for 2 hours prior to opening of the suction drain following a total hip replacement Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Total Hip Arthroplasty, Postoperative Blood Loss
- What is being tested?
- Tranexamic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2012to Apr 2020
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who will receive a unilateral total hip arthroplasty
Who cannot join
- coagulopathy
- allergy to tranexamic acid
- preoperative anemia (a hemoglobin value of < 11g/dL in females and < 12g/dL in males)
- fibrinolytic disorders
- a history of arterial or venous thromboembolic disease
- pregnancy
- breastfeeding
- major comorbidities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Topical Application of Tranexamic Acid in Total Hip Arthroplasty Through the Direct Anterior Approach. A Prospective, Double Blind, Placebo-controlled Clinical Trial.
The effects of topical application of 3g tranexamic acid for 2 hours prior to opening of the suction drain following a total hip replacement
- Conditions
- Total Hip Arthroplasty, Postoperative Blood Loss
- Being tested
- Tranexamic Acid, placebo
- Keywords
- total hip arthroplasty, tranexamic acid, postoperative blood loss
- Medical subject headings
- Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
3g of tranexamic acid is topically applied after THA. The drugs is left for 15 minutes or 2 hours
placeboDrug
The patients will receive 3g topical TXA for 15 minutes or 2 hours after THA. 33% of the patients will receive 3g of TXA trough a suction drain for 15 minutes after total hip arthroplasty, then the suction drain is opened. 33% will receive the same amount of TXA but the suction drain will only be opened 2 hours after application. The other patients will receive a placebo in the same manner
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Active comparator | The patients who receive placebo form the control group. The results can be compared with the results of the patients who did receive TXA Receives: Drug: placebo |
| Tranexamic acid | Placebo comparator | The patients will receive 3g topical TXA for 15 minutes or 2 hours after THA. 33% of the patients will receive 3g of TXA trough a suction drain for 15 minutes after total hip arthroplasty, then the suction drain is opened. 33% will receive the same amount of TXA but the suction drain will only be opened 2 hours after application. The other patients will receive a placebo in the same manner Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative blood loss in patients undergoing primary total hip arthroplasty
Measured: Haemoglobin levels, on which the postopererative blood loss is calculated, is measured preoperative and on day 1 and 4 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2020
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622946
- Sponsor's protocol ID
- 2010-024410-59
- Status last verified
- Nov 2020
- First submitted
- 14 Jun 2012
- Last updated
- 5 Nov 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Topical Application of Tranexamic Acid in Total Hip Arthroplasty Through the Direct Anterior Approach. A Prospective, Double Blind, Placebo-controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT01622946
- Acronym / sponsor ID
- 2010-024410-59
- Conditions
- Total Hip Arthroplasty, Postoperative Blood Loss
- Keywords
- total hip arthroplasty, tranexamic acid, postoperative blood loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 19 Jun 2012 (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 effects of topical application of 3g tranexamic acid for 2 hours prior to opening of the suction drain following a total hip replacement
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Active comparator | Drug: placeboThe patients who receive placebo form the control group. The results can be compared with the results of the patients who did receive TXA |
| Tranexamic acid | Placebo comparator | Drug: Tranexamic AcidThe patients will receive 3g topical TXA for 15 minutes or 2 hours after THA. 33% of the patients will receive 3g of TXA trough a suction drain for 15 minutes after total hip arthroplasty, then the suction drain is opened. 33% will receive the same amount of TXA but the suction drain will only be opened 2 hours after application. The other patients will receive a placebo in the same manner |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who will receive a unilateral total hip arthroplasty
Key exclusion criteria (8 listed)
- coagulopathy
- allergy to tranexamic acid
- preoperative anemia (a hemoglobin value of < 11g/dL in females and < 12g/dL in males)
- fibrinolytic disorders
- a history of arterial or venous thromboembolic disease
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 Acid3g of tranexamic acid is topically applied after THA. The drugs is left for 15 minutes or 2 hours | Drug | Tranexamic acid |
| placeboThe patients will receive 3g topical TXA for 15 minutes or 2 hours after THA. 33% of the patients will receive 3g of TXA trough a suction drain for 15 minutes after total hip arthroplasty, then the suction drain is opened. 33% will receive the same amount of TXA but the suction drain will only be opened 2 hours after application. The other patients will receive a placebo in the same manner | Drug | Placebo |
Primary outcome
postoperative blood loss in patients undergoing primary total hip arthroplasty
Time frame: Haemoglobin levels, on which the postopererative blood loss is calculated, is measured preoperative and on day 1 and 4 postoperative
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 5 Nov 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Total Hip Arthroplasty and Postoperative Blood Loss, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 8 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 5 Nov 2020. 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 Belgium. 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?
postoperative blood loss in patients undergoing primary total hip arthroplasty (time frame: Haemoglobin levels, on which the postopererative blood loss is calculated, is measured preoperative and on day 1 and 4 postoperative). 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 5 Nov 2020.