Tranexamic AcidNCT05874583
Prevention of Bleeding in Total Joint Replacement: Combined Route Administration of Tranexamic Acid
A study testing Combined route administration of Tranexamic acid and Intravenous route Tranexamic acid injection in people with Tranexamic Acid and Arthroplasty, Replacement, Knee, run by Mongi Slim Hospital at 1 site in Tunisia.
Trial summary
The investigators aimed to compare two doses of intravenous (IV) tranexamic acid (TXA) with a combined single dose of topical and IV TXA on haemoglobin decline 24 hours after total joint arthroplasties. The investigators conducted randomized, double-blind trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tranexamic Acid, Arthroplasty, Replacement, Knee, Blood Transfusion
- What is being tested?
- Combined route administration of Tranexamic acid and Intravenous route Tranexamic acid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Dec 2021to 31 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged of 18 years or more;
- Primary total hip or knee arthroplasty;
- A traumatic, degenerative or malformative setting.
Who cannot join
- Revisions;
- Bilateral procedures;
- Polytrauma;
- Pregnant patients;
- Contraindications for the use of TXA, Coagulation disorders or anaemia with Haemoglobin (Hb) less than or equal to 9 g/dl preoperatively;
- Patients treated with anticoagulants, Heparin, Warfarin, Oestrogen.
- Serious anaesthesia-related complications (impossible orotracheal intubation , anaphylactic shock);
- Severe transfusion reaction such as haemolysis.
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Mongi Slim University Hospital
La Marsa, Tunis Governorate, 2046
About this study
Official title: Prevention of Bleeding in Total Joint Replacement: Contribution of Combined Route in Tranexamic Acid Administration
The investigators aimed to compare two doses of intravenous (IV) tranexamic acid (TXA) with a combined single dose of topical and IV TXA on haemoglobin decline 24 hours after total joint arthroplasties.
The investigators conducted randomized, double-blind trial. The participants were randomized to either intrvenous group receiving 2 doses of 1 gram TXA in intravenous route 3 hours apart, or a combined application group receiving the first 1 gram IV and the topical dose was 1.5 gram after reduction of the fascia.
Read the detailed description
The investigators provided the pre-anaesthetic consultation. They carried out a rigorous clinical examination, a balancing of the defects and an adjustment of the therapies. The patients' written and informed consent was obtained. All patients had a preoperative blood count, blood grouping, renal assessment with dosage of uremia and creatinine. The investigators calculated the tolerable losses (mL). Randomization and allocation were carried out at this stage by an anesthesiologist other than the one managing the patient perioperatively.
On arrival in the operating room, the investigators set up the following systematic monitoring: electrocardioscope, pulse oximetry, gas analyzer, monitoring of capnia and curarization in the event of general anesthesia, non-invasive blood pressure. Two peripheral venous approaches were put in place. All patients received antibiotic prophylaxis with 2 g of Cefazolin and in case of allergy 900 mg of Dalacin. The anesthetic protocol was standardized. The choice between general or locoregional anesthesia was left to the discretion of the anesthesiologist treating the patient. For each patient, the investigators specified: The surgical approach, the type of prosthesis (cemented or not), the intraoperative posture, the duration of the procedure and of the anesthesia. During intraoperative monitoring, any hypotension with a decrease in mean arterial pressure of 20% of the baseline value for a period of more than 3 minutes or other complications were mentioned. The estimated bleeding (contents of the suction jar, number of drapes and compresses soaked in blood) with determination of the percentage of total losses intraoperatively as well as the results of the intraoperative blood count (if deemed necessary) were also specified. Transfusion of labile blood products was managed according to the patient's terrain, the degree of anemia, the speed of onset of the anemia and his hemodynamic tolerance. The analgesic protocol was also standardized.
- Conditions
- Tranexamic Acid, Arthroplasty, Replacement, Knee, Blood Transfusion, Arthroplasty, Replacement, Hip
- Being tested
- Combined route administration of Tranexamic acid, Intravenous route Tranexamic acid injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined route administration of Tranexamic acidDrug
Also called Intravenous and topical administration
tranexamic acid in topical route administration
Intravenous route Tranexamic acid injectionDrug
Also called Intravenously only
Intra venous route administration
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Group | Active comparator | patients receiving 2 doses of 1 g of tranexamic acid in in intra venous route 3 hours apart Receives: Drug: Intravenous route Tranexamic acid injection |
| Combined Group | Experimental | receiving the first 1g of tranexamic acid Intra venously and the second topical dose was 1,5g after reduction of the fascia. Receives: Drug: Combined route administration of Tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemoglobin decline
The decline of hemoglobin levels
Measured: up to 24 hours after surgery
Secondary outcomes (1)
The use of blood transfusion
Number of transfusion needed
Measured: up to 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start1 Dec 2021
- Primary completion30 Sep 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tranexamic AcidStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhamed Sami Mebazaa, Mongi Slim Hospital
- Investigators
- Mhamed Sami MS Mebazaa, Pr, Principal investigator, Mongi Slim local research ethical committee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874583
- Sponsor's protocol ID
- TXA in joint replacement
- Status last verified
- May 2023
- First submitted
- 26 Apr 2023
- Last updated
- 25 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Bleeding in Total Joint Replacement: Contribution of Combined Route in Tranexamic Acid Administration
- ClinicalTrials.gov ID
- NCT05874583
- Acronym / sponsor ID
- TXA in joint replacement
- Conditions
- Tranexamic Acid, Arthroplasty, Replacement, Knee, Blood Transfusion, Arthroplasty, Replacement, Hip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 25 May 2023 (actual)
- 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 investigators aimed to compare two doses of intravenous (IV) tranexamic acid (TXA) with a combined single dose of topical and IV TXA on haemoglobin decline 24 hours after total joint arthroplasties.
The investigators conducted randomized, double-blind trial. The participants were randomized to either intrvenous group receiving 2 doses of 1 gram TXA in intravenous route 3 hours apart, or a combined application group receiving the first 1 gram IV and the topical dose was 1.5 gram after reduction of the fascia.
Detailed description
The investigators provided the pre-anaesthetic consultation. They carried out a rigorous clinical examination, a balancing of the defects and an adjustment of the therapies. The patients' written and informed consent was obtained. All patients had a preoperative blood count, blood grouping, renal assessment with dosage of uremia and creatinine. The investigators calculated the tolerable losses (mL). Randomization and allocation were carried out at this stage by an anesthesiologist other than the one managing the patient perioperatively.
On arrival in the operating room, the investigators set up the following systematic monitoring: electrocardioscope, pulse oximetry, gas analyzer, monitoring of capnia and curarization in the event of general anesthesia, non-invasive blood pressure. Two peripheral venous approaches were put in place. All patients received antibiotic prophylaxis with 2 g of Cefazolin and in case of allergy 900 mg of Dalacin. The anesthetic protocol was standardized. The choice between general or locoregional anesthesia was left to the discretion of the anesthesiologist treating the patient. For each patient, the investigators specified: The surgical approach, the type of prosthesis (cemented or not), the intraoperative posture, the duration of the procedure and of the anesthesia. During intraoperative monitoring, any hypotension with a decrease in mean arterial pressure of 20% of the baseline value for a period of more than 3 minutes or other complications were mentioned. The estimated bleeding (contents of the suction jar, number of drapes and compresses soaked in blood) with determination of the percentage of total losses intraoperatively as well as the results of the intraoperative blood count (if deemed necessary) were also specified. Transfusion of labile blood products was managed according to the patient's terrain, the degree of anemia, the speed of onset of the anemia and his hemodynamic tolerance. The analgesic protocol was also standardized.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Group | Active comparator | Drug: Intravenous route Tranexamic acid injectionpatients receiving 2 doses of 1 g of tranexamic acid in in intra venous route 3 hours apart |
| Combined Group | Experimental | Drug: Combined route administration of Tranexamic acidreceiving the first 1g of tranexamic acid Intra venously and the second topical dose was 1,5g after reduction of the fascia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged of 18 years or more;
- Primary total hip or knee arthroplasty;
- A traumatic, degenerative or malformative setting.
Key exclusion criteria (8 listed)
- Revisions;
- Bilateral procedures;
- Polytrauma;
- Pregnant patients;
- Contraindications for the use of TXA, Coagulation disorders or anaemia with Haemoglobin (Hb) less than or equal to 9 g/dl preoperatively;
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 |
|---|---|---|
| Combined route administration of Tranexamic acidAlso: Intravenous and topical administrationtranexamic acid in topical route administration | Drug | Combined Group |
| Intravenous route Tranexamic acid injectionAlso: Intravenously onlyIntra venous route administration | Drug | Intravenous Group |
Primary outcome
Haemoglobin decline
Time frame: up to 24 hours after surgery
The decline of hemoglobin levels
1 secondary outcome
The use of blood transfusion
Time frame: up to 24 hours after surgery.
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 25 May 2023.
Related trials for Tranexamic Acid
Recruiting
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Scoliosis Idiopathic, Scoliosis; Adolescence
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
Enrolling by invitationPhase 4
Microneedling-Assisted Metformin, Tranexamic Acid, and Modified Kligman's Formula for Melasma
Melasma (Facial Melasma)
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Active, not recruitingPhase 4
Efficacy and Safety of Triple-Combination Cream Plus Microneedling Along With Tranexamic Acid Versus Platelet-Rich Plasma in the Treatment of Moderate-to-Severe Melasma: A Randomized Comparative Study
Melasma (Facial Melasma)
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.
Mhamed Sami MS Mebazaa, Pr principal investigator
Mongi Slim local research ethical committee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined route administration of Tranexamic acid and Intravenous route Tranexamic acid injection in people with Tranexamic Acid and Arthroplasty, Replacement, Knee, run by Mongi Slim Hospital at 1 site in Tunisia.
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 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 25 May 2023. 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 Tunisia. 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?
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?
Haemoglobin decline (time frame: up to 24 hours after 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 25 May 2023.