Blood Loss, SurgicalPhase 2NCT04187014
Oral Tranexamic Acid vs. Oral Aminocaproic Acid to Reduce Blood Loss After Total Hip Replacement
A Phase 2 study testing Aminocaproic Acid 1000Mg Tab and Tranexamic acid tablets in people with Blood Loss, Surgical, run by Carlos A Acosta-Olivo at 1 site in Mexico.
Trial summary
This study compares two oral medications (tranexamic acid and aminocaproic acid) as hemostatic agent administered in patients undergoing primary total hip replacement Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Blood Loss, Surgical
- What is being tested?
- Aminocaproic Acid 1000Mg Tab and Tranexamic acid tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteMexico
- Study dates
- 6 Feb 2020to 26 Apr 2021
- Phase
- Phase 2
- 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
- Age over 18 years
- Total replacement of the primary hip due to: 1) Primary Coxarthrosis, 2) Avascular hip necrosis, 3) Transcervical fracture
- Unilateral procedure
- Press-fit prosthesis
- Without the use of cement for the placement of the prosthesis
- Desire to participate voluntarily in the study and signature of informed consent
- Pre-operative assessment with result between ASA I, ASA II or ASA III performed and annexed in the clinical file either by the Department of Internal Medicine, Cardiology or Anesthesiology of our hospital.
- Possibility for oral administration of the drug.
Who cannot join
- History of thrombotic or embolic event in the last 6 months
- Clinical history of coagulopathy
- Previous surgeries in the hip to intervene
- Patients who have received aspirin, platelet or coumarinic antiplatelet agents in the week prior to surgery or NSAIDs two days prior to surgery.
- History of myocardial infarction, arteriopathy or unstable angina in the 12 months prior to surgery.
- Those patients whose preoperative assessment corresponds to an ASA IV or the procedure is contraindicated in its preoperative assessment.
Show all 16Show fewer
- Revision hip replacement
- Tumoral hip replacement
- Bilateral hip replacement
- Cognitive deficit
- Patients who meet the inclusion criteria but do not wish to participate in the study
- Patients with a diagnosis of Terminal Chronic Kidney Disease or with a serum creatinine higher than 1.47 mg / dl in the preoperative laboratories.
- Patients with inability to ingest the drug orally.
- Patients who are pregnant or breast-feeding or who are taking oral contraceptives.
- Seizure history
- Hypersensitivity to the active substance or to any of the excipients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Tranexamic Acid vs. Oral Aminocaproic Acid to Reduce Blood Loss, Transfusion Index and Complications After Total Hip Replacement. A Prospective, Randomized, Double Blind Clinical Trial
This study compares two oral medications (tranexamic acid and aminocaproic acid) as hemostatic agent administered in patients undergoing primary total hip replacement
Read the detailed description
With the aging population, the incidence of joint osteoarthritis is rising. Total hip arthroplasty (THA) is one of the most common surgeries used for the treatment of end-stage degenerative hip disease, which is almost always accompanied by joint pain, deformity and motor dysfunction.
Few articles have compared TXA and ε-ACA in joint arthroplasties. Whether ε-ACA has comparable hemostatic effects compared with TXA is unknown. A recent systematic review compared the effectiveness of TXA versus ε-ACA administered intravenously as a hemostatic agent in patients who had undergone a TKA and THR, and the results showed that the total blood loss was greater in the ε-ACA groups, but no significant differences between the two groups regarding transfusion rates were identified (Liu et al., 2018).
Regarding oral administration, two clinical trials compared the use of oral TXA versus intravenous and topical in patients who had undergone THA, reaching the conclusion that if efficiency, safety, and cost are considered the main crucial parameters during the evaluation of TXA administration methods, oral TXA stands as an efficacious, safe, and low-cost method to reduce blood loss after THA compared with the IV and topical forms. Additionally, considering the ease of drug administration in the tablet form, oral TXA appears to represent a superior mode of administration than IV and topical TXA (Kayupov et al., 2017; Luo et al., 2018).
The investigator's work team previously published a randomized controlled clinical trial in which it prospectively compared blood loss, transfusion rate and complications similar to this study but in total primary knee replacement, finding no differences with respect to any of the parameters studied except for the adverse effects, which were greater for the group that received tranexamic acid, this study was the first to compare the oral administration of these two medications in the field of orthopedics (Morales-Avalos et al., 2019) and the present protocol wants to do it now in the total primary hip replacement which is well known to be associated with greater blood loss than total knee replacement.
HYPOTHESIS: There are no significant differences in blood loss (total blood loss, external blood loss, hidden blood loss, intraoperative blood loss and drainage output), transfusion index, complications and hemoglobin/hematocrit levels in patients undergoing total hip prostheses treated with tranexamic acid or aminocaproic acid orally.
General objectives To compare the effect of oral aminocaproic acid as a hemostatic agent against oral tranexamic acid administered preoperatively and postoperatively in patients undergoing elective surgery of total hip replacement.
Specific objectives
- Selection and randomization of patients.
- Performing total hip replacement surgery and administration of AAC or AXA according to randomization and the methodology established in this protocol
- Establishment of a protocol for the administration of aminocaproic acid orally for its use as a hemostatic agent in elective surgery of total hip replacement.
- Determination of total blood loss, external blood loss, hidden blood loss, transfusion index, decrease in hemoglobin/hematocrit levels, drainage volume, intrahospital stay, analogous visual scale and SF-12 scale between tranexamic acid and the aminocaproic acid, both orally, in each group in the pre-operatively, trans operatively and post-operatively established times and compare them statistically.
- Determine and record the possible complications and side effects observed with the use of both drugs included in the study.
- Determine the cost and monetary savings associated with the administration of each drug.
- Comparison and statistical analysis of the results between the study groups.
- Conditions
- Blood Loss, Surgical
- Being tested
- Aminocaproic Acid 1000Mg Tab, Tranexamic acid tablets
- Keywords
- Total hip replacement, Oral tranexamic acid, Oral aminocaproic acid, Blood loss
- Medical subject headings
- Blood Loss, Surgical, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminocaproic Acid 1000Mg TabDrug
Also called Oral administration of aminocaproic acid
Oral administration of a total 6 g of aminocaproic acid to reduce blood loss
Tranexamic acid tabletsDrug
Also called Oral administration of tranexamic acid
Oral administration of 3.9 g of tranexamic acid to reduce blood loss
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Active comparator | Will be administered orally three times (administering 2 tablets each time). In the case of tranexamic acid are 650 mg each. The first administration will be two hours before the induction of anesthesia, the second 6 hours post-surgery and the third 12 hours after surgery. All by oral administration with a drink of water. The medicines will be administered with a volume of 40 ml of water.
For tranexamic acid a total dose of 3.9 grams (6 tablets) divided between the 3 administrations (1.3 grams each, ie 2 tablets of 650 mg) will be administered. Receives: Drug: Tranexamic acid tablets |
| Aminocaproic acid | Experimental | Will be administered orally three times (administering 2 tablets each time). In the case of aminocaproic tablets are 1000 mg each.The first administration will be two hours before the induction of anesthesia, the second 6 hours post-surgery and the third 12 hours after surgery. All by oral administration with a drink of water. The medicines will be administered with a volume of 40 ml of water.
For the aminocaproic acid, a total dose of 6 grams (6 tablets) divided between the 3 administrations (2 gram each, ie 2 tablets of 1000 mg) will be administered. Receives: Drug: Aminocaproic Acid 1000Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total blood loss (TBL)
Total blood loss 72 hours after surgery,The Gross and Nadler formula was used to calculate TBL. TBL = patient's blood volume (PBV) x (Hctpre - Hctpost)/Hctave (Hctpre = the initial pre-operative Hct level, Hctpost = the Hct on the morning of POD3). PBV = k1 x height (m) + k2 x weight (kg) + k3 (k1 = 0.3669, k2 = 0.03219, and k3 = 0.6041 for men; and k1 = 0.3561, k2 = 0.03308, and k3 = 0.1833 for women, Hctave = the average of the Hctpre and Hctpost)
Measured: The third day postoperative,at the time of obtaining the result of the hematocrit of 72 hours
External blood loss (EBL)
External blood loss (EBL) was estimated by adding the intraoperative bleeding and the blood in the drain collectors upon removal after 48 hours
Measured: On the second postoperative day (48 hours), when removing the surgical drainage.]
Hidden blood loss (HBL)
Defined as total blood loss minus external blood loss
Measured: The third day postoperative
Secondary outcomes (7)
Change in hematocrit level
Hematocrit levels obtained in 3 samples taken at different times postsurgery
Measured: Hematocrit levels will be measured at 24, 48 and 72 hours postsurgery
Drainage quantification
Drainage will be quantified in ml at 2 different times postsurgery
Measured: Drainage quantification will be registered at 24 and 48 hours postsurgery
Therapeutic effect on visual analog scale
The Visual Analog Scale is a unidimensional measure of pain intensity. The scale is most commonly anchored by "no pain " (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (scale of 10). It will be assessed as a numeric scale from 0 to 10.
Measured: Pain will be measured at 24, 48 and 72 hours postsurgery
Change in Hemoglobin level
Hemoglobin levels will be obtained in 3 samples taken at different times postsurgery
Measured: Hemoglobin levels will be measured at 24, 48 and 72 hours postsurgery
Rate of complications
Complications related to the surgery or to the administration of the study medication
Measured: at 24, 48 and 72 hours, 7 days, 4 and 6 weeks
Rate of transfusion
Need to administer globular packages following the indications of transfusion haemoglobin (Hb) of 8 g/dl in patients free of cardiovascular disease and Hb of 9 g/dl in patients with established cardiovascular disease or cardiovascular risk factors with symptoms of anaemia (defined as bad mental status, palpitation, or shortness of breath not due to other causes). Hb below 10 g/dl in patients with poor clinical tolerance of lower values was also an indication for transfusion. Symptoms of poor clinical tolerance of lower values were signs of hypoxia such as tachycardia, dyspnoea or syncope or drainage of more than 1 l of blood in the first 24 hours
Measured: at 24, 48 and 72 hours, 7 days, 4 and 6 weeks
Rate of intraoperative blood loss
Intra-operative blood loss was calculated using the difference between the weights of the used gauze and the original unused gauze (25 cm x 25 cm, monolayer, weight of 30 grams), in addition to the blood volume accumulated in suction bottles subtracting the volume of saline solution during the surgery
Measured: Immediately after the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start6 Feb 2020
- Primary completion26 Apr 2021
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Blood Loss, SurgicalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two study groups will be generated, each consisting of 45 research subjects, randomly each recipient will receive 3 doses of one of the two study drugs (tranexamic acid or aminocaproic acid). The group to which the patient belongs will be assigned through a computer program, the patient will not know to which group he belongs or what medication he will receive. The patients will be extracted from the external traumatology clinic
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carlos A Acosta-Olivo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon
- Investigators
- Carlos Acosta-Olivo, PhD, Study chair, Universidad Autonoma de Nuevo Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187014
- Sponsor's protocol ID
- OR19-00003
- Status last verified
- Apr 2021
- First submitted
- 2 Dec 2019
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kayupov E, Fillingham YA, Okroj K, Plummer DR, Moric M, Gerlinger TL, Della Valle CJ. Oral and Intravenous Tranexamic Acid Are Equivalent at Reducing Blood Loss Following Total Hip Arthroplasty: A Randomized Controlled Trial. J Bone Joint Surg Am. 2017 Mar 1;99(5):373-378. doi: 10.2106/JBJS.16.00188.
PubMed 28244907Luo ZY, Wang HY, Wang D, Zhou K, Pei FX, Zhou ZK. Oral vs Intravenous vs Topical Tranexamic Acid in Primary Hip Arthroplasty: A Prospective, Randomized, Double-Blind, Controlled Study. J Arthroplasty. 2018 Mar;33(3):786-793. doi: 10.1016/j.arth.2017.09.062. Epub 2017 Oct 6.
PubMed 29107495Liu Q, Geng P, Shi L, Wang Q, Wang P. Tranexamic acid versus aminocaproic acid for blood management after total knee and total hip arthroplasty: A systematic review and meta-analysis. Int J Surg. 2018 Jun;54(Pt A):105-112. doi: 10.1016/j.ijsu.2018.04.042. Epub 2018 May 1.
PubMed 29723672Morales-Avalos R, Ramos-Morales T, Espinoza-Galindo AM, Garay-Mendoza D, Pena-Martinez VM, Marfil-Rivera LJ, Garza-Ocanas L, Acosta-Olivo C, Cerda-Barbosa JK, Valdes-Gonzalez NL, Vilchez-Cavazos F. First Comparative Study of the Effectiveness of the Use of Tranexamic Acid against epsilon-Aminocaproic Acid via the Oral Route for the Reduction of Postoperative Bleeding in TKA: A Clinical Trial. J Knee Surg. 2021 Mar;34(4):383-405. doi: 10.1055/s-0039-1696722. Epub 2019 Sep 6.
PubMed 31491796
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Tranexamic Acid vs. Oral Aminocaproic Acid to Reduce Blood Loss, Transfusion Index and Complications After Total Hip Replacement. A Prospective, Randomized, Double Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT04187014
- Acronym / sponsor ID
- OR19-00003
- Conditions
- Blood Loss, Surgical
- Keywords
- Total hip replacement, Oral tranexamic acid, Oral aminocaproic acid, Blood loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Carlos A Acosta-OlivoUniversity, hospital or other
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 5 Dec 2019 (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.
This study compares two oral medications (tranexamic acid and aminocaproic acid) as hemostatic agent administered in patients undergoing primary total hip replacement
Detailed description
With the aging population, the incidence of joint osteoarthritis is rising. Total hip arthroplasty (THA) is one of the most common surgeries used for the treatment of end-stage degenerative hip disease, which is almost always accompanied by joint pain, deformity and motor dysfunction.
Few articles have compared TXA and ε-ACA in joint arthroplasties. Whether ε-ACA has comparable hemostatic effects compared with TXA is unknown. A recent systematic review compared the effectiveness of TXA versus ε-ACA administered intravenously as a hemostatic agent in patients who had undergone a TKA and THR, and the results showed that the total blood loss was greater in the ε-ACA groups, but no significant differences between the two groups regarding transfusion rates were identified (Liu et al., 2018).
Regarding oral administration, two clinical trials compared the use of oral TXA versus intravenous and topical in patients who had undergone THA, reaching the conclusion that if efficiency, safety, and cost are considered the main crucial parameters during the evaluation of TXA administration methods, oral TXA stands as an efficacious, safe, and low-cost method to reduce blood loss after THA compared with the IV and topical forms. Additionally, considering the ease of drug administration in the tablet form, oral TXA appears to represent a superior mode of administration than IV and topical TXA (Kayupov et al., 2017; Luo et al., 2018).
The investigator's work team previously published a randomized controlled clinical trial in which it prospectively compared blood loss, transfusion rate and complications similar to this study but in total primary knee replacement, finding no differences with respect to any of the parameters studied except for the adverse effects, which were greater for the group that received tranexamic acid, this study was the first to compare the oral administration of these two medications in the field of orthopedics (Morales-Avalos et al., 2019) and the present protocol wants to do it now in the total primary hip replacement which is well known to be associated with greater blood loss than total knee replacement.
HYPOTHESIS: There are no significant differences in blood loss (total blood loss, external blood loss, hidden blood loss, intraoperative blood loss and drainage output), transfusion index, complications and hemoglobin/hematocrit levels in patients undergoing total hip prostheses treated with tranexamic acid or aminocaproic acid orally.
General objectives To compare the effect of oral aminocaproic acid as a hemostatic agent against oral tranexamic acid administered preoperatively and postoperatively in patients undergoing elective surgery of total hip replacement.
Specific objectives
- Selection and randomization of patients.
- Performing total hip replacement surgery and administration of AAC or AXA according to randomization and the methodology established in this protocol
- Establishment of a protocol for the administration of aminocaproic acid orally for its use as a hemostatic agent in elective surgery of total hip replacement.
- Determination of total blood loss, external blood loss, hidden blood loss, transfusion index, decrease in hemoglobin/hematocrit levels, drainage volume, intrahospital stay, analogous visual scale and SF-12 scale between tranexamic acid and the aminocaproic acid, both orally, in each group in the pre-operatively, trans operatively and post-operatively established times and compare them statistically.
- Determine and record the possible complications and side effects observed with the use of both drugs included in the study.
- Determine the cost and monetary savings associated with the administration of each drug.
- Comparison and statistical analysis of the results between the study groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Two study groups will be generated, each consisting of 45 research subjects, randomly each recipient will receive 3 doses of one of the two study drugs (tranexamic acid or aminocaproic acid). The group to which the patient belongs will be assigned through a computer program, the patient will not know to which group he belongs or what medication he will receive. The patients will be extracted from the external traumatology clinic
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Active comparator | Drug: Tranexamic acid tabletsWill be administered orally three times (administering 2 tablets each time). In the case of tranexamic acid are 650 mg each. The first administration will be two hours before the induction of anesthesia, the second 6 hours post-surgery and the third 12 hours after surgery. All by oral administration with a drink of water. The medicines will be administered with a volume of 40 ml of water. For tranexamic acid a total dose of 3.9 grams (6 tablets) divided between the 3 administrations (1.3 grams each, ie 2 tablets of 650 mg) will be administered. |
| Aminocaproic acid | Experimental | Drug: Aminocaproic Acid 1000Mg TabWill be administered orally three times (administering 2 tablets each time). In the case of aminocaproic tablets are 1000 mg each.The first administration will be two hours before the induction of anesthesia, the second 6 hours post-surgery and the third 12 hours after surgery. All by oral administration with a drink of water. The medicines will be administered with a volume of 40 ml of water. For the aminocaproic acid, a total dose of 6 grams (6 tablets) divided between the 3 administrations (2 gram each, ie 2 tablets of 1000 mg) will be administered. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age over 18 years
- Total replacement of the primary hip due to: 1) Primary Coxarthrosis, 2) Avascular hip necrosis, 3) Transcervical fracture
- Unilateral procedure
- Press-fit prosthesis
- Without the use of cement for the placement of the prosthesis
Key exclusion criteria (16 listed)
- History of thrombotic or embolic event in the last 6 months
- Clinical history of coagulopathy
- Previous surgeries in the hip to intervene
- Patients who have received aspirin, platelet or coumarinic antiplatelet agents in the week prior to surgery or NSAIDs two days prior to surgery.
- History of myocardial infarction, arteriopathy or unstable angina in the 12 months prior to surgery.
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 |
|---|---|---|
| Aminocaproic Acid 1000Mg TabAlso: Oral administration of aminocaproic acidOral administration of a total 6 g of aminocaproic acid to reduce blood loss | Drug | Aminocaproic acid |
| Tranexamic acid tabletsAlso: Oral administration of tranexamic acidOral administration of 3.9 g of tranexamic acid to reduce blood loss | Drug | Tranexamic acid |
Primary outcome
Total blood loss (TBL)
Time frame: The third day postoperative,at the time of obtaining the result of the hematocrit of 72 hours
Total blood loss 72 hours after surgery,The Gross and Nadler formula was used to calculate TBL. TBL = patient's blood volume (PBV) x (Hctpre - Hctpost)/Hctave (Hctpre = the initial pre-operative Hct level, Hctpost = the Hct on the morning of POD3). PBV = k1 x height (m) + k2 x weight (kg) + k3 (k1 = 0.3669, k2 = 0.03219, and k3 = 0.6041 for men; and k1 = 0.3561, k2 = 0.03308, and k3 = 0.1833 for women, Hctave = the average of the Hctpre and Hctpost)
External blood loss (EBL)
Time frame: On the second postoperative day (48 hours), when removing the surgical drainage.]
External blood loss (EBL) was estimated by adding the intraoperative bleeding and the blood in the drain collectors upon removal after 48 hours
Hidden blood loss (HBL)
Time frame: The third day postoperative
Defined as total blood loss minus external blood loss
7 secondary outcomes
Change in hematocrit level
Time frame: Hematocrit levels will be measured at 24, 48 and 72 hours postsurgery
Drainage quantification
Time frame: Drainage quantification will be registered at 24 and 48 hours postsurgery
Therapeutic effect on visual analog scale
Time frame: Pain will be measured at 24, 48 and 72 hours postsurgery
Change in Hemoglobin level
Time frame: Hemoglobin levels will be measured at 24, 48 and 72 hours postsurgery
Rate of complications
Time frame: at 24, 48 and 72 hours, 7 days, 4 and 6 weeks
Rate of transfusion
Time frame: at 24, 48 and 72 hours, 7 days, 4 and 6 weeks
Rate of intraoperative blood loss
Time frame: Immediately after the end of the 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 28 Apr 2021.
- Results publication: PubMed 28244907Kayupov E, Fillingham YA, Okroj K, Plummer DR, Moric M, Gerlinger TL, Della Valle CJ. Oral and Intravenous Tranexamic Acid Are Equivalent at Reducing Blood Loss Following Total Hip Arthroplasty: A Randomized Controlled Trial. J Bone Joint Surg Am. 2017 Mar 1;99(5):373-378. doi: 10.2106/JBJS.16.00188.
- Results publication: PubMed 29107495Luo ZY, Wang HY, Wang D, Zhou K, Pei FX, Zhou ZK. Oral vs Intravenous vs Topical Tranexamic Acid in Primary Hip Arthroplasty: A Prospective, Randomized, Double-Blind, Controlled Study. J Arthroplasty. 2018 Mar;33(3):786-793. doi: 10.1016/j.arth.2017.09.062. Epub 2017 Oct 6.
- Results publication: PubMed 29723672Liu Q, Geng P, Shi L, Wang Q, Wang P. Tranexamic acid versus aminocaproic acid for blood management after total knee and total hip arthroplasty: A systematic review and meta-analysis. Int J Surg. 2018 Jun;54(Pt A):105-112. doi: 10.1016/j.ijsu.2018.04.042. Epub 2018 May 1.
- Results publication: PubMed 31491796Morales-Avalos R, Ramos-Morales T, Espinoza-Galindo AM, Garay-Mendoza D, Pena-Martinez VM, Marfil-Rivera LJ, Garza-Ocanas L, Acosta-Olivo C, Cerda-Barbosa JK, Valdes-Gonzalez NL, Vilchez-Cavazos F. First Comparative Study of the Effectiveness of the Use of Tranexamic Acid against epsilon-Aminocaproic Acid via the Oral Route for the Reduction of Postoperative Bleeding in TKA: A Clinical Trial. J Knee Surg. 2021 Mar;34(4):383-405. doi: 10.1055/s-0039-1696722. Epub 2019 Sep 6.
- Individual participant dataSharing planned: No
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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.
Carlos Acosta-Olivo, PhD study chair
Universidad Autonoma de Nuevo Leon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aminocaproic Acid 1000Mg Tab and Tranexamic acid tablets in people with Blood Loss, Surgical, run by Carlos A Acosta-Olivo at 1 site in Mexico.
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 8 inclusion and 16 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 28 Apr 2021. 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 Mexico. 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?
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 blood loss (TBL) (time frame: The third day postoperative,at the time of obtaining the result of the hematocrit of 72 hours). The study lists 3 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 NCT04187014, which also lists 4 linked publications.
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 28 Apr 2021.