Femoral Neck FracturesNCT06701695
Efficacy of Intraoperative Periarticular Injections in Hip Fracture Hemiarthroplasty
A study testing Periarticular Injection (PAI) in people with Femoral Neck Fractures and Hemiarthroplasty, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The objective of this study was to assess the effectiveness of the intraoperative periarticular solution in reducing blood loss and minimizing transfusion requirements in patients with femoral neck fractures who underwent hemiarthroplasty. Read more about this study
- Who is it for?
- Ages 58 to 95 years
- Conditions the study is for
- Femoral Neck Fractures, Hemiarthroplasty, Blood Loss Requiring Transfusion
- What is being tested?
- Periarticular Injection (PAI)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 May 2020to 13 Feb 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 58 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of femoral neck fracture
Who cannot join
- Anti-aggregant, anti-coagulant or anti-thrombotic therapy
- Pathological fractures, periprosthetic fractures, or revision procedures
- Intolerance or allergy to the medications utilized in the study
- Refused to participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Intraoperative Periarticular Injections in Reducing Blood Loss and Transfusion Requirements in Hip Fracture Hemiarthroplasty: A Randomized Controlled Trial
The objective of this study was to assess the effectiveness of the intraoperative periarticular solution in reducing blood loss and minimizing transfusion requirements in patients with femoral neck fractures who underwent hemiarthroplasty.
Read the detailed description
Hip fractures in the elderly represent a significant public health challenge, marked by elevated rates of morbidity and mortality. The worldwide increase in life expectancy has led to a corresponding rise in the incidence of hip fractures. Notably, increased perioperative blood loss has been identified as a critical factor that heightens the risk of complications and mortality. Consequently, contemporary research efforts have focused on addressing this pivotal issue. Various strategies have been developed, including controlled hypotensive anesthesia and the utilization of pharmacological agents aimed at reducing the perioperative blood products. The necessity for the efficacy of tranexamic acid (TXA) in mitigating blood loss has been well-established across numerous surgical specialties. This study is motivated by the need for an effective and safe approach to perioperative blood salvage. To date, there appears to be a lack of research examining the effectiveness of the intraoperative periarticular injection technique (100 mL periarticular solution comprising 200 mg of bupivacaine (40 mL), 60 mg of ketorolac (2 mL), 8 mg of dexamethasone (2 mL), 2 mg of 1:1000 epinephrine (2 mL), and standard saline solution (54 mL). This solution was prepared in two 50 mL syringes. The first syringe containing 50 mL of the cocktail was injected into the capsule and gluteal muscles before femoral stem insertion. Following joint capsule closure, the second syringe containing 50 mL of the periarticular injection cocktail was infiltrated into the fascia lata muscle, subcutaneous tissue, and wound layers) regarding blood loss reduction. Therefore, this study aims to investigate the following questions: 1) Is intraoperative periarticular injection an effective technique for minimizing blood loss in patients with hip fractures? and 2) What proportion of the salvaged blood loss can be attributed to hidden blood loss?
- Being tested
- Periarticular Injection (PAI), Control (Standard treatment)
- Keywords
- Hip Fracture, Hemiarthroplasty, Periarticular injection, Blood loss, Blood transfusion requirement
- Medical subject headings
- Femoral Neck Fractures, Hip Fractures, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periarticular Injection (PAI)Procedure or surgery
Patients in the periarticular injection group were administered a 100 mL periarticular solution comprising 200 mg of bupivacaine (40 mL), 60 mg of ketorolac (2 mL), 8 mg of dexamethasone (2 mL), 2 mg of 1:1000 epinephrine (2 mL), and standard saline solution (54 mL). This solution was prepared in two 50 mL syringes. The first syringe containing 50 mL of the cocktail was injected into the capsule and gluteal muscles prior to femoral stem insertion. Following joint capsule closure, the second syringe containing 50 mL of the periarticular injection cocktail was infiltrated into the fascia lata muscle, subcutaneous tissue, and wound layers.
Control (Standard treatment)Procedure or surgery
The control group received the conventional treatment protocol.
| Study group | Role | What they receive |
|---|---|---|
| Periarticular injection group | Active comparator | Patients in the periarticular injection group were administered a 100 mL periarticular solution comprising 200 mg of bupivacaine (40 mL), 60 mg of ketorolac (2 mL), 8 mg of dexamethasone (2 mL), 2 mg of 1:1000 epinephrine (2 mL), and standard saline solution (54 mL). This solution was prepared in two 50 mL syringes. The first syringe containing 50 mL of the cocktail was injected into the capsule and gluteal muscles before femoral stem insertion. Following joint capsule closure, the second syringe containing 50 mL of the periarticular injection cocktail was infiltrated into the fascia lata muscle, subcutaneous tissue, and wound layers. Receives: Procedure: Periarticular Injection (PAI); Procedure: Control (Standard treatment) |
| Control group | Sham comparator | Participants in the control group underwent standard hemiarthroplasty treatment, with no administration of periarticular injections. Receives: Procedure: Control (Standard treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Blood Loss
The calculation of Total Blood Volume (TBV) was conducted using the following manner:
TBV= k1 x H3 + k2 x W+ k3 For males, k1 = 0.3669, k2 = 0.03219, and k3 = 0.1833; for females, k1 = 0.3561, k2 = 0.03308, and k3 = 0.1833; H=height (m) and W=weight (kg)
The calculation of Total blood loss (TBL) was conducted using the Gross formula method as follows:
TBL= TBV x (Preoperative HCT (Hematocrit) - Postoperative 3-day HCT) / Mean HCT
Measured: Preoperative and postoperative hematocrit (HCT) and hemoglobin (Hb) levels measured over the first three days
Secondary outcomes (1)
Hidden Blood Loss
Intraoperative Blood Loss (IBL) was determined through anesthesia recordings during the operation, which included measuring blood suction bottles and the weight of surgical swabs.
Visible Blood Loss = Intraoperative Blood Loss + Postoperative suction drain volume The Total Hidden Blood Loss (HBL) volume was determined by deducting the visible blood loss volume from the TBL volume.
Measured: Postoperative first three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start11 May 2020
- Primary completion13 Feb 2022
- Study completion13 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups were established, one serving as the control group receiving standard hemiarthroplasty treatment.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TANER KARLIDAĞ, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701695
- Sponsor's protocol ID
- AnkaraCHBilkent-ORT-TK-01
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In the event that reviewers make such a request, participant data may be made available for sharing in the future.
Publications
Keating EM. Preoperative evaluation and methods to reduce blood use in orthopedic surgery. Anesthesiol Clin North Am. 2005 Jun;23(2):305-13, vi-vii. doi: 10.1016/j.atc.2005.02.006.
PubMed 15922902Desai SJ, Wood KS, Marsh J, Bryant D, Abdo H, Lawendy AR, Sanders DW. Factors affecting transfusion requirement after hip fracture: can we reduce the need for blood? Can J Surg. 2014 Oct;57(5):342-8. doi: 10.1503/cjs.030413.
PubMed 25265109Liodakis E, Antoniou J, Zukor DJ, Huk OL, Epure LM, Bergeron SG. Major Complications and Transfusion Rates After Hemiarthroplasty and Total Hip Arthroplasty for Femoral Neck Fractures. J Arthroplasty. 2016 Sep;31(9):2008-12. doi: 10.1016/j.arth.2016.02.019. Epub 2016 Feb 17.
PubMed 26975602Moran CG, Wenn RT, Sikand M, Taylor AM. Early mortality after hip fracture: is delay before surgery important? J Bone Joint Surg Am. 2005 Mar;87(3):483-9. doi: 10.2106/JBJS.D.01796.
PubMed 15741611Carson JL, Poses RM, Spence RK, Bonavita G. Severity of anaemia and operative mortality and morbidity. Lancet. 1988 Apr 2;1(8588):727-9. doi: 10.1016/s0140-6736(88)91536-x.
PubMed 2895260Veronese N, Maggi S. Epidemiology and social costs of hip fracture. Injury. 2018 Aug;49(8):1458-1460. doi: 10.1016/j.injury.2018.04.015. Epub 2018 Apr 20.
PubMed 29699731Gross JB. Estimating allowable blood loss: corrected for dilution. Anesthesiology. 1983 Mar;58(3):277-80. doi: 10.1097/00000542-198303000-00016. No abstract available.
PubMed 6829965Turan S, Bingol O. Is tranexamic acid effective on hidden blood loss in patients during total knee arthroplasty? Jt Dis Relat Surg. 2020;31(3):488-493. doi: 10.5606/ehc.2020.78024.
PubMed 32962580Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; CONSORT. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28-55. doi: 10.1016/j.ijsu.2011.10.001. Epub 2011 Oct 12.
PubMed 22036893Liu W, Deng S, Liang J. Tranexamic acid usage in hip fracture surgery: a meta-analysis and meta-regression analysis of current practice. Arch Orthop Trauma Surg. 2022 Oct;142(10):2769-2789. doi: 10.1007/s00402-021-04231-1. Epub 2021 Oct 28.
PubMed 34709457Li ZJ, Zhao MW, Zeng L. Additional Dose of Intravenous Tranexamic Acid after Primary Total Knee Arthroplasty Further Reduces Hidden Blood Loss. Chin Med J (Engl). 2018 Mar 20;131(6):638-642. doi: 10.4103/0366-6999.226884.
PubMed 29521284Smith GH, Tsang J, Molyneux SG, White TO. The hidden blood loss after hip fracture. Injury. 2011 Feb;42(2):133-5. doi: 10.1016/j.injury.2010.02.015. Epub 2010 Mar 16.
PubMed 20236640Watts CD, Houdek MT, Sems SA, Cross WW, Pagnano MW. Tranexamic Acid Safely Reduced Blood Loss in Hemi- and Total Hip Arthroplasty for Acute Femoral Neck Fracture: A Randomized Clinical Trial. J Orthop Trauma. 2017 Jul;31(7):345-351. doi: 10.1097/BOT.0000000000000837.
PubMed 28633147Baskaran D, Rahman S, Salmasi Y, Froghi S, Berber O, George M. Effect of tranexamic acid use on blood loss and thromboembolic risk in hip fracture surgery: systematic review and meta-analysis. Hip Int. 2018 Jan;28(1):3-10. doi: 10.5301/hipint.5000556.
PubMed 28983887Foss NB, Kehlet H. Hidden blood loss after surgery for hip fracture. J Bone Joint Surg Br. 2006 Aug;88(8):1053-9. doi: 10.1302/0301-620X.88B8.17534.
PubMed 16877605
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intraoperative Periarticular Injections in Reducing Blood Loss and Transfusion Requirements in Hip Fracture Hemiarthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06701695
- Acronym / sponsor ID
- AnkaraCHBilkent-ORT-TK-01
- Keywords
- Hip Fracture, Hemiarthroplasty, Periarticular injection, Blood loss, Blood transfusion requirement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 11 May 2020 (actual)
- Primary completion
- 13 Feb 2022 (actual)
- Study completion
- 13 Feb 2022 (actual)
- First posted
- 22 Nov 2024 (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 objective of this study was to assess the effectiveness of the intraoperative periarticular solution in reducing blood loss and minimizing transfusion requirements in patients with femoral neck fractures who underwent hemiarthroplasty.
Detailed description
Hip fractures in the elderly represent a significant public health challenge, marked by elevated rates of morbidity and mortality. The worldwide increase in life expectancy has led to a corresponding rise in the incidence of hip fractures. Notably, increased perioperative blood loss has been identified as a critical factor that heightens the risk of complications and mortality. Consequently, contemporary research efforts have focused on addressing this pivotal issue. Various strategies have been developed, including controlled hypotensive anesthesia and the utilization of pharmacological agents aimed at reducing the perioperative blood products. The necessity for the efficacy of tranexamic acid (TXA) in mitigating blood loss has been well-established across numerous surgical specialties. This study is motivated by the need for an effective and safe approach to perioperative blood salvage. To date, there appears to be a lack of research examining the effectiveness of the intraoperative periarticular injection technique (100 mL periarticular solution comprising 200 mg of bupivacaine (40 mL), 60 mg of ketorolac (2 mL), 8 mg of dexamethasone (2 mL), 2 mg of 1:1000 epinephrine (2 mL), and standard saline solution (54 mL). This solution was prepared in two 50 mL syringes. The first syringe containing 50 mL of the cocktail was injected into the capsule and gluteal muscles before femoral stem insertion. Following joint capsule closure, the second syringe containing 50 mL of the periarticular injection cocktail was infiltrated into the fascia lata muscle, subcutaneous tissue, and wound layers) regarding blood loss reduction. Therefore, this study aims to investigate the following questions: 1) Is intraoperative periarticular injection an effective technique for minimizing blood loss in patients with hip fractures? and 2) What proportion of the salvaged blood loss can be attributed to hidden blood loss?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups were established, one serving as the control group receiving standard hemiarthroplasty treatment.
| Arm | Type | Receives |
|---|---|---|
| Periarticular injection group | Active comparator | Procedure: Periarticular Injection (PAI), Procedure: Control (Standard treatment)Patients in the periarticular injection group were administered a 100 mL periarticular solution comprising 200 mg of bupivacaine (40 mL), 60 mg of ketorolac (2 mL), 8 mg of dexamethasone (2 mL), 2 mg of 1:1000 epinephrine (2 mL), and standard saline solution (54 mL). This solution was prepared in two 50 mL syringes. The first syringe containing 50 mL of the cocktail was injected into the capsule and gluteal muscles before femoral stem insertion. Following joint capsule closure, the second syringe containing 50 mL of the periarticular injection cocktail was infiltrated into the fascia lata muscle, subcutaneous tissue, and wound layers. |
| Control group | Sham comparator | Procedure: Control (Standard treatment)Participants in the control group underwent standard hemiarthroplasty treatment, with no administration of periarticular injections. |
Who may qualify
- Ages
- 58 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of femoral neck fracture
Key exclusion criteria (4 listed)
- Anti-aggregant, anti-coagulant or anti-thrombotic therapy
- Pathological fractures, periprosthetic fractures, or revision procedures
- Intolerance or allergy to the medications utilized in the study
- Refused to participation
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 |
|---|---|---|
| Periarticular Injection (PAI)Patients in the periarticular injection group were administered a 100 mL periarticular solution comprising 200 mg of bupivacaine (40 mL), 60 mg of ketorolac (2 mL), 8 mg of dexamethasone (2 mL), 2 mg of 1:1000 epinephrine (2 mL), and standard saline solution (54 mL). This solution was prepared in two 50 mL syringes. The first syringe containing 50 mL of the cocktail was injected into the capsule and gluteal muscles prior to femoral stem insertion. Following joint capsule closure, the second syringe containing 50 mL of the periarticular injection cocktail was infiltrated into the fascia lata muscle, subcutaneous tissue, and wound layers. | Procedure or surgery | Periarticular injection group |
| Control (Standard treatment)The control group received the conventional treatment protocol. | Procedure or surgery | Control group, Periarticular injection group |
Primary outcome
Total Blood Loss
Time frame: Preoperative and postoperative hematocrit (HCT) and hemoglobin (Hb) levels measured over the first three days
The calculation of Total Blood Volume (TBV) was conducted using the following manner: TBV= k1 x H3 + k2 x W+ k3 For males, k1 = 0.3669, k2 = 0.03219, and k3 = 0.1833; for females, k1 = 0.3561, k2 = 0.03308, and k3 = 0.1833; H=height (m) and W=weight (kg) The calculation of Total blood loss (TBL) was conducted using the Gross formula method as follows: TBL= TBV x (Preoperative HCT (Hematocrit) - Postoperative 3-day HCT) / Mean HCT
1 secondary outcome
Hidden Blood Loss
Time frame: Postoperative first three days
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 Nov 2024.
- Results publication: PubMed 15922902Keating EM. Preoperative evaluation and methods to reduce blood use in orthopedic surgery. Anesthesiol Clin North Am. 2005 Jun;23(2):305-13, vi-vii. doi: 10.1016/j.atc.2005.02.006.
- Results publication: PubMed 25265109Desai SJ, Wood KS, Marsh J, Bryant D, Abdo H, Lawendy AR, Sanders DW. Factors affecting transfusion requirement after hip fracture: can we reduce the need for blood? Can J Surg. 2014 Oct;57(5):342-8. doi: 10.1503/cjs.030413.
- Results publication: PubMed 26975602Liodakis E, Antoniou J, Zukor DJ, Huk OL, Epure LM, Bergeron SG. Major Complications and Transfusion Rates After Hemiarthroplasty and Total Hip Arthroplasty for Femoral Neck Fractures. J Arthroplasty. 2016 Sep;31(9):2008-12. doi: 10.1016/j.arth.2016.02.019. Epub 2016 Feb 17.
- Results publication: PubMed 15741611Moran CG, Wenn RT, Sikand M, Taylor AM. Early mortality after hip fracture: is delay before surgery important? J Bone Joint Surg Am. 2005 Mar;87(3):483-9. doi: 10.2106/JBJS.D.01796.
- Results publication: PubMed 2895260Carson JL, Poses RM, Spence RK, Bonavita G. Severity of anaemia and operative mortality and morbidity. Lancet. 1988 Apr 2;1(8588):727-9. doi: 10.1016/s0140-6736(88)91536-x.
- Results publication: PubMed 29699731Veronese N, Maggi S. Epidemiology and social costs of hip fracture. Injury. 2018 Aug;49(8):1458-1460. doi: 10.1016/j.injury.2018.04.015. Epub 2018 Apr 20.
- Results publication: PubMed 6829965Gross JB. Estimating allowable blood loss: corrected for dilution. Anesthesiology. 1983 Mar;58(3):277-80. doi: 10.1097/00000542-198303000-00016. No abstract available.
- Results publication: PubMed 32962580Turan S, Bingol O. Is tranexamic acid effective on hidden blood loss in patients during total knee arthroplasty? Jt Dis Relat Surg. 2020;31(3):488-493. doi: 10.5606/ehc.2020.78024.
- Results publication: PubMed 22036893Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; CONSORT. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28-55. doi: 10.1016/j.ijsu.2011.10.001. Epub 2011 Oct 12.
- Results publication: PubMed 34709457Liu W, Deng S, Liang J. Tranexamic acid usage in hip fracture surgery: a meta-analysis and meta-regression analysis of current practice. Arch Orthop Trauma Surg. 2022 Oct;142(10):2769-2789. doi: 10.1007/s00402-021-04231-1. Epub 2021 Oct 28.
- Results publication: PubMed 29521284Li ZJ, Zhao MW, Zeng L. Additional Dose of Intravenous Tranexamic Acid after Primary Total Knee Arthroplasty Further Reduces Hidden Blood Loss. Chin Med J (Engl). 2018 Mar 20;131(6):638-642. doi: 10.4103/0366-6999.226884.
- Results publication: PubMed 20236640Smith GH, Tsang J, Molyneux SG, White TO. The hidden blood loss after hip fracture. Injury. 2011 Feb;42(2):133-5. doi: 10.1016/j.injury.2010.02.015. Epub 2010 Mar 16.
- Individual participant dataSharing planned: No. In the event that reviewers make such a request, participant data may be made available for sharing in the future.
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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 study testing Periarticular Injection (PAI) in people with Femoral Neck Fractures and Hemiarthroplasty, run by Ankara City Hospital Bilkent 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 1 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: finished, as of the sponsor's last update on 25 Nov 2024. 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.
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 (time frame: Preoperative and postoperative hematocrit (HCT) and hemoglobin (Hb) levels measured over the first three days). 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 NCT06701695, which also lists 19 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 25 Nov 2024.