Osteogenesis ImperfectaNCT05321199
Tranexamic Acid During Telescoping Nail Application In Osteogenesis Imperfecta
A study testing Tranexamic acid in people with Osteogenesis Imperfecta, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this study is to assess the effective of intraoperative use of tranexamic acid in reducing blood loss during telescoping nail application in cases of osteogenesis imperfecta. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteogenesis Imperfecta
- What is being tested?
- Tranexamic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 30 Nov 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All patients with osteogenesis imperfecta who will undergo telescoping femoral nail application in Assiut University Hospital - Department of Orthopaedic and Trauma Surgery between April 2022 and March 2023.
Who cannot join
- Known allergy to Tranexamic Acid
- History of any acquired disturbances of colour vision
- History of major comorbidities (e.g., severe ischemic heart disease)
- Refusal of blood products
- History of fibrinolytic disorders requiring intraoperative antifibrinolytic treatment, coagulopathy in the past and/or as identified by a preoperative platelet count of <150,000/mm3, or a prolonged partial thromboplastin time, active intravascular clotting \& known congenital thrombophilia
- Preoperative use of anticoagulant therapy within five days before surgery
Show all 9Show fewer
- Medical Unfit
- Participation in another clinical trial involving pharmaceutical drugs.
- Patients or their relatives who refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Intraoperative Use of Tranexamic Acid in Reducing Blood Loss During Telescoping Nail Application in Osteogenesis Imperfecta - Randomized Control Trials
The aim of this study is to assess the effective of intraoperative use of tranexamic acid in reducing blood loss during telescoping nail application in cases of osteogenesis imperfecta.
Read the detailed description
Osteogenesis imperfecta (OI) is a rare inherited pathology that consists of abnormal type one collagen synthesis that affects all structures in the body. The most important and early sign of this pathology is the appearance of fractures after low-energy trauma, progressive bowing of long bones, joint instability, and chronic bone pain. The most used classification is the one created by Sillence that initially had four types and now is expended to more than 15 types. A new nomenclature was published in 2014 in order to simplify the classification and help understand such an intricate pathology. Clinically, all systems in the body are affected, but changes to the musculoskeletal are the most severe; besides, a variable degree of bone brittleness is present. Patients are suffering from severe hyperlaxity, short stature, scoliosis, progressive bowing of the limbs, and chronic bone pain due to continuous microfractures.
The surgical treatment of osteogenesis imperfecta (OI) is negatively influenced by clinical features such as osteoporosis, limb deformities and bone changes caused by bisphosphonate therapy. Blood loss during telescoping nail application in patients with Osteogenesis Imperfecta is a serious problem especially patients with Osteogenesis Imperfecta type III are considered at high risk of blood loss during surgery because of capillary fragility and an altered platelet function.
Tranexamic acid (TXA) is an antifibrinolytic drug that has been shown to be effective in reducing blood loss and the need for transfusions after several orthopaedic surgeries.
However, the effectiveness of tranexamic acid use in application of telescoping nail in osteogenesis imperfecta still remains unclear and no previously available study about this subject. The purpose of this study is to assess the effectiveness of intraoperative use of intravenous (IV) tranexamic acid in reducing total blood loss and transfusion rates for patients who will be operated with telescoping nail application for osteogenesis imperfecta.
Each patient with osteogenesis imperfecta, who consecutively will undergo telescoping femoral nail application with intraoperative use of tranexamic acid during 2022-2023, will be recruited in the study.
A total of 40 patients undergoing telescoping femoral nail application for osteogenesis imperfecta will be including in a prospective randomized study.
Taking detailed history and full clinical examination to exclude the presence of any medical disorder that prevents use of Tranexamic acid. Preoperative lab investigations are Complete Blood Count (CBC) to determine Hemoglobin HB level and Hematocrit value preoperatively.
Operations will be performing under general anesthesia, no tourniquet is using, and the intraoperative regime will be the same for all patients. Patients will be dividing into 2 groups; in group A (control); patients receiving no tranexamic acid, in group B (case); patients receiving 10-15mg/kg or 1g of tranexamic acid intravenously, given 30 minutes before skin incision in telescoping femoral nail application followed by another dose of intravenous tranexamic acid (10-15mg/kg; body weight average 1g) at time of wound closure.
Intraoperative blood loss shall be quantified by measuring irrigation fluid and the weight of surgical sponges used to dry the field intraoperatively by the researcher plus amount of blood in suction drain.
Comparison of blood loss between patients with first femoral osteotomy and patients with previous recurrent femoral osteotomies.
- Conditions
- Osteogenesis Imperfecta
- Being tested
- Tranexamic acid
- Medical subject headings
- Osteogenesis Imperfecta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called Kapron
Tranexamic acid (TXA) is an antifibrinolytic drug that has been shown to be effective in reducing blood loss and the need for transfusions after several orthopaedic surgeries.
| Study group | Role | What they receive |
|---|---|---|
| Control patients | Experimental | Closed Envelope for group A (control); patients receiving no tranexamic acid. With Double-Blind Study in which the participants and observers are unaware of who receives tranexamic acid. The total blood loss (TBL), intraoperative blood loss (IBL), postoperative blood loss (PBL), hemoglobin (HGB) levels and Hematocrit value (Hct) on preoperatively (pre-op) and postoperatively, and amount of allogenic blood transfusion were recorded. Furthermore, the general information was also compared between groups. Receives: Drug: Tranexamic acid |
| Case patients | Experimental | Closed Envelope for group B (case); patients receiving tranexamic acid intravenously and topically. With Double-Blind Study in which the participants and observers are unaware of who receives tranexamic acid. The total blood loss (TBL), intraoperative blood loss (IBL), postoperative blood loss (PBL), hemoglobin (HGB) levels and Hematocrit value (Hct) on preoperatively (pre-op) and postoperatively, and amount of allogenic blood transfusion were recorded. Furthermore, the general information was also compared between groups. Receives: Drug: Tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of change in mean blood loss in tranexamic acid group.
Based on determining the main outcome variable, the estimated minimum required sample size is 40 patients (20 in each group).
The sample size was calculated using G*power software 3.1.9.2., based on the following assumptions:
Main outcome variable is intraoperative blood loss in cases of Osteogenesis Imperfecta undergoing telescoping nail application which receive tranexamic acid vs. not received it.
Main statistical test is one sided t-test to detect the difference between the two groups.
Alpha = 0.05, Power = 0.80, Effect size = 0.81, Allocation ratio= 1
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start1 May 2022
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Osteogenesis ImperfectaStudies of the same condition, open and under way.
- More trials run by Assiut 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ammar Jamal Aldeen Mohammed Mohammed, Assiut University
- Investigators
- Hesham Elbaseet, Lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321199
- Sponsor's protocol ID
- TXA in OI
- Status last verified
- Dec 2023
- First submitted
- 11 Mar 2022
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sillence DO, Senn A, Danks DM. Genetic heterogeneity in osteogenesis imperfecta. J Med Genet. 1979 Apr;16(2):101-16. doi: 10.1136/jmg.16.2.101.
PubMed 458828Forlino A, Cabral WA, Barnes AM, Marini JC. New perspectives on osteogenesis imperfecta. Nat Rev Endocrinol. 2011 Jun 14;7(9):540-57. doi: 10.1038/nrendo.2011.81.
PubMed 21670757Van Dijk FS, Sillence DO. Osteogenesis imperfecta: clinical diagnosis, nomenclature and severity assessment. Am J Med Genet A. 2014 Jun;164A(6):1470-81. doi: 10.1002/ajmg.a.36545. Epub 2014 Apr 8.
PubMed 24715559Palomo T, Fassier F, Ouellet J, Sato A, Montpetit K, Glorieux FH, Rauch F. Intravenous Bisphosphonate Therapy of Young Children With Osteogenesis Imperfecta: Skeletal Findings During Follow Up Throughout the Growing Years. J Bone Miner Res. 2015 Dec;30(12):2150-7. doi: 10.1002/jbmr.2567. Epub 2015 Jun 30.
PubMed 26059976Thomas IH, DiMeglio LA. Advances in the Classification and Treatment of Osteogenesis Imperfecta. Curr Osteoporos Rep. 2016 Feb;14(1):1-9. doi: 10.1007/s11914-016-0299-y.
PubMed 26861807Hathaway WE, Solomons CC, Ott JE. Platelet function and pyrophosphates in osteogenesis imperfecta. Blood. 1972 Apr;39(4):500-9. No abstract available.
PubMed 4334923Armstrong D, VanWormer D, Solomons CC. Increased inorganic serum pyrophosphate in serum and urine of patients with osteogenesis imperfecta. Clin Chem. 1975 Jan;21(1):104-8. No abstract available.
PubMed 163711Russell RG, Bisaz S, Donath A, Morgan DB, Fleisch H. Inorganic pyrophosphate in plasma in normal persons and in patients with hypophosphatasia, osteogenesis imperfecta, and other disorders of bone. J Clin Invest. 1971 May;50(5):961-9. doi: 10.1172/JCI106589.
PubMed 4324072Jennings JD, Solarz MK, Haydel C. Application of Tranexamic Acid in Trauma and Orthopedic Surgery. Orthop Clin North Am. 2016 Jan;47(1):137-43. doi: 10.1016/j.ocl.2015.08.014.
PubMed 26614928Faraoni D, Goobie SM. The efficacy of antifibrinolytic drugs in children undergoing noncardiac surgery: a systematic review of the literature. Anesth Analg. 2014 Mar;118(3):628-36. doi: 10.1213/ANE.0000000000000080.
PubMed 24557107
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intraoperative Use of Tranexamic Acid in Reducing Blood Loss During Telescoping Nail Application in Osteogenesis Imperfecta - Randomized Control Trials
- ClinicalTrials.gov ID
- NCT05321199
- Acronym / sponsor ID
- TXA in OI
- Conditions
- Osteogenesis Imperfecta
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 11 Apr 2022 (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 aim of this study is to assess the effective of intraoperative use of tranexamic acid in reducing blood loss during telescoping nail application in cases of osteogenesis imperfecta.
Detailed description
Osteogenesis imperfecta (OI) is a rare inherited pathology that consists of abnormal type one collagen synthesis that affects all structures in the body. The most important and early sign of this pathology is the appearance of fractures after low-energy trauma, progressive bowing of long bones, joint instability, and chronic bone pain. The most used classification is the one created by Sillence that initially had four types and now is expended to more than 15 types. A new nomenclature was published in 2014 in order to simplify the classification and help understand such an intricate pathology. Clinically, all systems in the body are affected, but changes to the musculoskeletal are the most severe; besides, a variable degree of bone brittleness is present. Patients are suffering from severe hyperlaxity, short stature, scoliosis, progressive bowing of the limbs, and chronic bone pain due to continuous microfractures.
The surgical treatment of osteogenesis imperfecta (OI) is negatively influenced by clinical features such as osteoporosis, limb deformities and bone changes caused by bisphosphonate therapy. Blood loss during telescoping nail application in patients with Osteogenesis Imperfecta is a serious problem especially patients with Osteogenesis Imperfecta type III are considered at high risk of blood loss during surgery because of capillary fragility and an altered platelet function.
Tranexamic acid (TXA) is an antifibrinolytic drug that has been shown to be effective in reducing blood loss and the need for transfusions after several orthopaedic surgeries.
However, the effectiveness of tranexamic acid use in application of telescoping nail in osteogenesis imperfecta still remains unclear and no previously available study about this subject. The purpose of this study is to assess the effectiveness of intraoperative use of intravenous (IV) tranexamic acid in reducing total blood loss and transfusion rates for patients who will be operated with telescoping nail application for osteogenesis imperfecta.
Each patient with osteogenesis imperfecta, who consecutively will undergo telescoping femoral nail application with intraoperative use of tranexamic acid during 2022-2023, will be recruited in the study.
A total of 40 patients undergoing telescoping femoral nail application for osteogenesis imperfecta will be including in a prospective randomized study.
Taking detailed history and full clinical examination to exclude the presence of any medical disorder that prevents use of Tranexamic acid. Preoperative lab investigations are Complete Blood Count (CBC) to determine Hemoglobin HB level and Hematocrit value preoperatively.
Operations will be performing under general anesthesia, no tourniquet is using, and the intraoperative regime will be the same for all patients. Patients will be dividing into 2 groups; in group A (control); patients receiving no tranexamic acid, in group B (case); patients receiving 10-15mg/kg or 1g of tranexamic acid intravenously, given 30 minutes before skin incision in telescoping femoral nail application followed by another dose of intravenous tranexamic acid (10-15mg/kg; body weight average 1g) at time of wound closure.
Intraoperative blood loss shall be quantified by measuring irrigation fluid and the weight of surgical sponges used to dry the field intraoperatively by the researcher plus amount of blood in suction drain.
Comparison of blood loss between patients with first femoral osteotomy and patients with previous recurrent femoral osteotomies.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control patients | Experimental | Drug: Tranexamic acidClosed Envelope for group A (control); patients receiving no tranexamic acid. With Double-Blind Study in which the participants and observers are unaware of who receives tranexamic acid. The total blood loss (TBL), intraoperative blood loss (IBL), postoperative blood loss (PBL), hemoglobin (HGB) levels and Hematocrit value (Hct) on preoperatively (pre-op) and postoperatively, and amount of allogenic blood transfusion were recorded. Furthermore, the general information was also compared between groups. |
| Case patients | Experimental | Drug: Tranexamic acidClosed Envelope for group B (case); patients receiving tranexamic acid intravenously and topically. With Double-Blind Study in which the participants and observers are unaware of who receives tranexamic acid. The total blood loss (TBL), intraoperative blood loss (IBL), postoperative blood loss (PBL), hemoglobin (HGB) levels and Hematocrit value (Hct) on preoperatively (pre-op) and postoperatively, and amount of allogenic blood transfusion were recorded. Furthermore, the general information was also compared between groups. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with osteogenesis imperfecta who will undergo telescoping femoral nail application in Assiut University Hospital - Department of Orthopaedic and Trauma Surgery between April 2022 and March 2023.
Key exclusion criteria (9 listed)
- Known allergy to Tranexamic Acid
- History of any acquired disturbances of colour vision
- History of major comorbidities (e.g., severe ischemic heart disease)
- Refusal of blood products
- History of fibrinolytic disorders requiring intraoperative antifibrinolytic treatment, coagulopathy in the past and/or as identified by a preoperative platelet count of <150,000/mm3, or a prolonged partial thromboplastin time, active intravascular clotting \& known congenital thrombophilia
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: KapronTranexamic acid (TXA) is an antifibrinolytic drug that has been shown to be effective in reducing blood loss and the need for transfusions after several orthopaedic surgeries. | Drug | Case patients, Control patients |
Primary outcome
Percentage of change in mean blood loss in tranexamic acid group.
Time frame: Baseline
Based on determining the main outcome variable, the estimated minimum required sample size is 40 patients (20 in each group). The sample size was calculated using G*power software 3.1.9.2., based on the following assumptions: Main outcome variable is intraoperative blood loss in cases of Osteogenesis Imperfecta undergoing telescoping nail application which receive tranexamic acid vs. not received it. Main statistical test is one sided t-test to detect the difference between the two groups. Alpha = 0.05, Power = 0.80, Effect size = 0.81, Allocation ratio= 1
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 14 Dec 2023.
- Background: PubMed 458828Sillence DO, Senn A, Danks DM. Genetic heterogeneity in osteogenesis imperfecta. J Med Genet. 1979 Apr;16(2):101-16. doi: 10.1136/jmg.16.2.101.
- Background: PubMed 21670757Forlino A, Cabral WA, Barnes AM, Marini JC. New perspectives on osteogenesis imperfecta. Nat Rev Endocrinol. 2011 Jun 14;7(9):540-57. doi: 10.1038/nrendo.2011.81.
- Background: PubMed 24715559Van Dijk FS, Sillence DO. Osteogenesis imperfecta: clinical diagnosis, nomenclature and severity assessment. Am J Med Genet A. 2014 Jun;164A(6):1470-81. doi: 10.1002/ajmg.a.36545. Epub 2014 Apr 8.
- Background: PubMed 26059976Palomo T, Fassier F, Ouellet J, Sato A, Montpetit K, Glorieux FH, Rauch F. Intravenous Bisphosphonate Therapy of Young Children With Osteogenesis Imperfecta: Skeletal Findings During Follow Up Throughout the Growing Years. J Bone Miner Res. 2015 Dec;30(12):2150-7. doi: 10.1002/jbmr.2567. Epub 2015 Jun 30.
- Background: PubMed 26861807Thomas IH, DiMeglio LA. Advances in the Classification and Treatment of Osteogenesis Imperfecta. Curr Osteoporos Rep. 2016 Feb;14(1):1-9. doi: 10.1007/s11914-016-0299-y.
- Background: PubMed 4334923Hathaway WE, Solomons CC, Ott JE. Platelet function and pyrophosphates in osteogenesis imperfecta. Blood. 1972 Apr;39(4):500-9. No abstract available.
- Background: PubMed 163711Armstrong D, VanWormer D, Solomons CC. Increased inorganic serum pyrophosphate in serum and urine of patients with osteogenesis imperfecta. Clin Chem. 1975 Jan;21(1):104-8. No abstract available.
- Background: PubMed 4324072Russell RG, Bisaz S, Donath A, Morgan DB, Fleisch H. Inorganic pyrophosphate in plasma in normal persons and in patients with hypophosphatasia, osteogenesis imperfecta, and other disorders of bone. J Clin Invest. 1971 May;50(5):961-9. doi: 10.1172/JCI106589.
- Background: PubMed 26614928Jennings JD, Solarz MK, Haydel C. Application of Tranexamic Acid in Trauma and Orthopedic Surgery. Orthop Clin North Am. 2016 Jan;47(1):137-43. doi: 10.1016/j.ocl.2015.08.014.
- Background: PubMed 24557107Faraoni D, Goobie SM. The efficacy of antifibrinolytic drugs in children undergoing noncardiac surgery: a systematic review of the literature. Anesth Analg. 2014 Mar;118(3):628-36. doi: 10.1213/ANE.0000000000000080.
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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.
Hesham Elbaseet, Lecturer study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic acid in people with Osteogenesis Imperfecta, run by Assiut University at 1 site in Egypt.
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 9 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 14 Dec 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 Egypt. 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?
Percentage of change in mean blood loss in tranexamic acid group. (time frame: Baseline). 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 NCT05321199, which also lists 10 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 14 Dec 2023.