HemorrhagePhase 4NCT02094066
The Effect of Tranexamic Acid for Total Hip Arthroplasty
A Phase 4 study testing tranexamic acid and serum physiologic in people with Hemorrhage, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effects of tranexamic acid on hemorrhage, blood transfusion, fibrin degradation products and kidney functions for total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemorrhage
- What is being tested?
- tranexamic acid and serum physiologic
- 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 siteTurkey (Türkiye)
- Study dates
- Mar 2014to Jul 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 2-3
- 18-75 age
- total hip arthroplasty surgery
- regional anesthesia
Who cannot join
- allergies to drug
- liver and kidney failure
- ischemic heart disease
- coagulopathy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erciyes univercity medicine faculty
Kayseri, 38039
seher orbay yasli, resident, +905052401933, sehersin81@hotmail.com
zeynep tosun, prof, +905326640648, zeynep@erciyes.edu.tr
About this study
Official title: The Effects of High Doze Tranexamic Acid Application on Hemorrhage, Blood Transfusion, Fibrin Degradation Products, and Kidney Functions for Total Hip Arthroplasty
The aim of this study is to investigate the effects of tranexamic acid on hemorrhage, blood transfusion, fibrin degradation products and kidney functions for total hip arthroplasty.
Read the detailed description
Orthopedic surgery may be associated with substantial blood loss requiring transfusion of erythrocytes.Transfusion of allogeneic erythrocytes is not free of adverse events and has been associated with transmission of infectious diseases, increased postoperative bacterial infection, immune sensitization, and transfusion related acute lung injury. Measures taken to allay concerns about the safety of blood transfusions have translated into the increasing cost of allogeneic blood units. Blood banks regularly undergo blood shortages. For these reasons, there is a need to reduce allogeneic blood transfusions. A number of effective interventions have been developed, such as preoperative autologous donation, cell salvage, or the use of erythropoietin. Pharmacologic agents such as aprotinin, tranexamic acid, or epsilon-aminocaproic acid (EACA) could reduce perioperative blood loss by interfering with fibrinolysis.
- Conditions
- Hemorrhage
- Being tested
- tranexamic acid, serum physiologic
- Keywords
- tranexamic acid, total hip arthroplasty
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tranexamic acidDrug
Also called lysteda
preoperative ıv 50 mg/kg tranexamic acid infusion at 45 minutes
serum physiologicDrug
preoperative 100 cc ıv serum physiologic
| Study group | Role | What they receive |
|---|---|---|
| tranexamic acid | Active comparator | preoperative ıv 50 mg/kg tranexamic acid infusion at 45 minutes Receives: Drug: tranexamic acid |
| serum physiologic | Sham comparator | preoperative 100 cc serum physiologic Receives: Drug: serum physiologic |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemorrhage
the amount of bleeding in aspirator and sponges
Measured: intraoperative
Secondary outcomes (1)
erythrocyte transfusion
Measured: intraoperative and postoperative 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seher orbay yasli, TC Erciyes University
- Investigators
- seher orbay yasli, resident, Principal investigator, Erciyes university medicine faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094066
- Sponsor's protocol ID
- 2012/683
- Status last verified
- Mar 2014
- First submitted
- 19 Mar 2014
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of High Doze Tranexamic Acid Application on Hemorrhage, Blood Transfusion, Fibrin Degradation Products, and Kidney Functions for Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02094066
- Acronym / sponsor ID
- 2012/683
- Conditions
- Hemorrhage
- Keywords
- tranexamic acid, total hip arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 21 Mar 2014 (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 aim of this study is to investigate the effects of tranexamic acid on hemorrhage, blood transfusion, fibrin degradation products and kidney functions for total hip arthroplasty.
Detailed description
Orthopedic surgery may be associated with substantial blood loss requiring transfusion of erythrocytes.Transfusion of allogeneic erythrocytes is not free of adverse events and has been associated with transmission of infectious diseases, increased postoperative bacterial infection, immune sensitization, and transfusion related acute lung injury. Measures taken to allay concerns about the safety of blood transfusions have translated into the increasing cost of allogeneic blood units. Blood banks regularly undergo blood shortages. For these reasons, there is a need to reduce allogeneic blood transfusions. A number of effective interventions have been developed, such as preoperative autologous donation, cell salvage, or the use of erythropoietin. Pharmacologic agents such as aprotinin, tranexamic acid, or epsilon-aminocaproic acid (EACA) could reduce perioperative blood loss by interfering with fibrinolysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tranexamic acid | Active comparator | Drug: tranexamic acidpreoperative ıv 50 mg/kg tranexamic acid infusion at 45 minutes |
| serum physiologic | Sham comparator | Drug: serum physiologicpreoperative 100 cc serum physiologic |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA 2-3
- 18-75 age
- total hip arthroplasty surgery
- regional anesthesia
Key exclusion criteria (4 listed)
- allergies to drug
- liver and kidney failure
- ischemic heart disease
- coagulopathy
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: lystedapreoperative ıv 50 mg/kg tranexamic acid infusion at 45 minutes | Drug | tranexamic acid |
| serum physiologicpreoperative 100 cc ıv serum physiologic | Drug | serum physiologic |
Primary outcome
hemorrhage
Time frame: intraoperative
the amount of bleeding in aspirator and sponges
1 secondary outcome
erythrocyte transfusion
Time frame: intraoperative and postoperative 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
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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.
seher orbay yasli, resident principal investigator
Erciyes university medicine faculty
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 serum physiologic in people with Hemorrhage, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 26 Mar 2014. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact seher orbay yasli, resident (+905052401933, sehersin81@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemorrhage (time frame: intraoperative). 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 26 Mar 2014.