Fractures, BonePhase 2FAANCT06795698

The Effect of Prophylactic Anticoagulation on Major Bleeding Events in Hospitalized Chronic Kidney Disease and Lower Limb Fracture Patients.

A Phase 2 study testing Enoxaparin in people with Fractures, Bone and CKD Stage 4, run by Hospital Civil de Guadalajara at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

the risk of bleeding may be greater than the benefit of antithrombotic protection when prophylactically anticoagulating a patient with a lower limb fracture and advanced CKD. The primary objective was to evaluate the risk major bleeding in patients with lower limb fractures and advance CKD. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Fractures, Bone, CKD Stage 4, CKD Stage 3
What is being tested?: Enoxaparin
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 61 participants
Where: 1 siteMexico
Study dates: 1 Mar 2019to 1 Dec 2024
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

lower limb fracture before surgery
CKD (chonic kidney disease)

Who cannot join

<18 years old
kidney transplant
hospital stay <48 hours
had received any anticoagulant before random assignment to a patient group
had missing data that would render analysis incomplete

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Hospital Civil de Guadalajara
Guadalajara, Jalisco, 44240

Other trials in Mexico

About this study

Official title: The Effect of Prophylactic Anticoagulation on Major Bleeding Events in Hospitalized Chronic Kidney Disease and Lower Limb Fracture Patients. a Phase 2, Randomized, Doble Blind, Control Trial

the risk of bleeding may be greater than the benefit of antithrombotic protection when prophylactically anticoagulating a patient with a lower limb fracture and advanced CKD.

The primary objective was to evaluate the risk major bleeding in patients with lower limb fractures and advance CKD. The secondary objectives were to assess major bleeding in patients with lower limb fractures in CKD stage 4 and 5, thrombosis, death.

Conditions: Fractures, Bone, CKD Stage 4, CKD Stage 3, CKD Stage 5, Enoxaparin Adverse Reaction, Anticoagulant-induced Bleeding
Being tested: Enoxaparin
Keywords: chronic kidney disease, anticoagulation, bleeding, bone fracture, thrombosis
Medical subject headings: Fractures, Bone, Renal Insufficiency, Chronic, Venous Thrombosis, Hemorrhage, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EnoxaparinDrug
enoxaparin 1mg/kg of ideal body weight subcutaneous every 24 hours in patients with eGFR <30ml/min/1.73m2

Study groups in NCT06795698
Study group	Role	What they receive
Anticoagulation	Active comparator	The intervention drug of interest was prophylactic anticoagulation with enoxaparin 1mg/kg of ideal body weight subcutaneous every 24 hours in patients with eGFR <30ml/min/1.73m2 (REF); enoxaparin will continue till surgery, any mandatory adverse event, dead or discharge. Enoxaparin or placebo started on admission to the trial, stopped 12 hours before surgery and all patients received prophylaxis anticoagulation restarted 6 to 12 hours postoperatively according to orthopedic surgeon practices. We choose enoxaparin, a low molecular weight heparin according to the ACCP guidelines as the gold standard for VTE prophylaxis in orthopedic patients Receives: Drug: Enoxaparin
No anticoagulation	Placebo comparator	The no anticoagulation strategy was considerate the control group, we choose as placebo a bolus of 10ml normal saline 0.9%, was prepared and administered behind a screen or curtain, and the drug was administered through normal IV tubes Receives: Drug: Enoxaparin

What is being measured

The primary outcome is the main question the study is designed to answer.

Major bleeding
Number of Participants with Major bleeding were defined according to the International Society on Thrombosis and Haemostasis (ISTH) criteria (Schulman S). Defined as the composed event of: 1- Fatal bleeding, and/or; 2- Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or; 3- Bleeding causing a fall in hemoglobin level of 2.0 g/dL or more, or leading to transfusion of two or more units of whole blood or red cells
Measured: From date of randomization until the date of first documented major bleeding or death from any cause, whichever came first up to 20 days. From date of randomization until surgery. Pre-intervention/procedure/surgery.

Secondary outcomes (5)

Thrombosis
Number of Participants with Thrombosis was defined as the occurrence of a definite or probable venous thromboembolism (VTE) event. As deep vein thrombosis (DVT) typically presents with pain, swelling, warmth, or erythema of the affected limb
Measured: From date of randomization until the date of first documented thrombosis, or date of death from any cause, whichever came first, assessed from date of randomization until surgery up to 20 days. Pre-intervention/procedure/surgery.
Dead
Number of Participants dead
Measured: through study completion, an average of 3 weeks
number of transfusions
Number of transfusions presurgery
Measured: From date of randomization until the date of first documented transfusions and number of transfusions. Pre-intervention/procedure/surgery.
acute kidney injury
Number of Participants with acute kidney injury, defined as an increses in serum creatinine >0.3mg/dL during 48 hours period
Measured: From date of randomization until the date of first documented acute kidney injury up to 20 days. From date of randomization until surgery. Pre-intervention/procedure/surgery.
hospitalization days
number of days in hospital.
Measured: number of days in hospital. through study completion, an average of 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20191 Dec 2024

First posted28 Jan 2025
Study start1 Mar 2019
Primary completion1 Dec 2024
Study completion1 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Fractures, BoneStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: two groups recieved anticoagulation or placebo since randomization
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06795698
Sponsor's protocol ID: 257/18
Acronym: FAA
Status last verified: Jan 2025
First submitted: 28 Dec 2024
Last updated: 28 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The files and data are in the physical and electronic archives of the Civil Hospital of Guadalajara Fray Antonio Alcalde and can be requested with prior authorization. All data generated or analyzed during this study are included in this article. Further inquiries can be directed to the corresponding author.

Publications

Lieberman JR, Bell JA. Venous Thromboembolic Prophylaxis After Total Hip and Knee Arthroplasty. J Bone Joint Surg Am. 2021 Aug 18;103(16):1556-1564. doi: 10.2106/JBJS.20.02250.
PubMed 34133395
Naylor KL, McArthur E, Leslie WD, Fraser LA, Jamal SA, Cadarette SM, Pouget JG, Lok CE, Hodsman AB, Adachi JD, Garg AX. The three-year incidence of fracture in chronic kidney disease. Kidney Int. 2014 Oct;86(4):810-8. doi: 10.1038/ki.2013.547. Epub 2014 Jan 15.
PubMed 24429401
Runesson B, Trevisan M, Iseri K, Qureshi AR, Lindholm B, Barany P, Elinder CG, Carrero JJ. Fractures and their sequelae in non-dialysis-dependent chronic kidney disease: the Stockholm CREAtinine Measurement project. Nephrol Dial Transplant. 2020 Nov 1;35(11):1908-1915. doi: 10.1093/ndt/gfz142.
PubMed 31361316
Kim SM, Long J, Montez-Rath M, Leonard M, Chertow GM. Hip Fracture in Patients With Non-Dialysis-Requiring Chronic Kidney Disease. J Bone Miner Res. 2016 Oct;31(10):1803-1809. doi: 10.1002/jbmr.2862. Epub 2016 Jul 11.
PubMed 27145189
Vilaca T, Salam S, Schini M, Harnan S, Sutton A, Poku E, Allen IE, Cummings SR, Eastell R. Risks of Hip and Nonvertebral Fractures in Patients With CKD G3a-G5D: A Systematic Review and Meta-analysis. Am J Kidney Dis. 2020 Oct;76(4):521-532. doi: 10.1053/j.ajkd.2020.02.450. Epub 2020 Jul 9.
PubMed 32654892
Isakova T, Cai X, Lee J, Mehta R, Zhang X, Yang W, Nessel L, Anderson AH, Lo J, Porter A, Nunes JW, Negrea L, Hamm L, Horwitz E, Chen J, Scialla JJ, de Boer IH, Leonard MB, Feldman HI, Wolf M; CRIC Study Investigators. Longitudinal Evolution of Markers of Mineral Metabolism in Patients With CKD: The Chronic Renal Insufficiency Cohort (CRIC) Study. Am J Kidney Dis. 2020 Feb;75(2):235-244. doi: 10.1053/j.ajkd.2019.07.022. Epub 2019 Oct 23.
PubMed 31668375
Burlacu A, Genovesi S, Goldsmith D, Rossignol P, Ortiz A, Kalra PA, Malyszko J, Banach M, Kanbay M, Covic A. Bleeding in advanced CKD patients on antithrombotic medication - A critical appraisal. Pharmacol Res. 2018 Mar;129:535-543. doi: 10.1016/j.phrs.2017.12.004. Epub 2017 Dec 5.
PubMed 29208494
Flevas DA, Megaloikonomos PD, Dimopoulos L, Mitsiokapa E, Koulouvaris P, Mavrogenis AF. Thromboembolism prophylaxis in orthopaedics: an update. EFORT Open Rev. 2018 Apr 27;3(4):136-148. doi: 10.1302/2058-5241.3.170018. eCollection 2018 Apr.
PubMed 29780621
Reiss AB, Voloshyna I, De Leon J, Miyawaki N, Mattana J. Cholesterol Metabolism in CKD. Am J Kidney Dis. 2015 Dec;66(6):1071-82. doi: 10.1053/j.ajkd.2015.06.028. Epub 2015 Sep 1.
PubMed 26337134
Morris GK, Henry AP, Preston BJ. Prevention of deep-vein thrombosis by low-dose heparin in patients undergoing total hip replacement. Lancet. 1974 Oct 5;2(7884):797-800. doi: 10.1016/s0140-6736(74)91069-1. No abstract available.
PubMed 4138248
Pellegrini VD Jr, Clement D, Lush-Ehmann C, Keller GS, Evarts CM. The John Charnley Award. Natural history of thromboembolic disease after total hip arthroplasty. Clin Orthop Relat Res. 1996 Dec;(333):27-40.
PubMed 8981880
White RH, Zhou H, Romano PS. Incidence of symptomatic venous thromboembolism after different elective or urgent surgical procedures. Thromb Haemost. 2003 Sep;90(3):446-55. doi: 10.1160/TH03-03-0152.
PubMed 12958614
Santana DC, Emara AK, Orr MN, Klika AK, Higuera CA, Krebs VE, Molloy RM, Piuzzi NS. An Update on Venous Thromboembolism Rates and Prophylaxis in Hip and Knee Arthroplasty in 2020. Medicina (Kaunas). 2020 Aug 19;56(9):416. doi: 10.3390/medicina56090416.
PubMed 32824931
Gould MK, Garcia DA, Wren SM, Karanicolas PJ, Arcelus JI, Heit JA, Samama CM. Prevention of VTE in nonorthopedic surgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e227S-e277S. doi: 10.1378/chest.11-2297.
PubMed 22315263
Douketis JD, Spyropoulos AC, Murad MH, Arcelus JI, Dager WE, Dunn AS, Fargo RA, Levy JH, Samama CM, Shah SH, Sherwood MW, Tafur AJ, Tang LV, Moores LK. Perioperative Management of Antithrombotic Therapy: An American College of Chest Physicians Clinical Practice Guideline. Chest. 2022 Nov;162(5):e207-e243. doi: 10.1016/j.chest.2022.07.025. Epub 2022 Aug 11.
PubMed 35964704

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
Active, not recruitingObservational study
The Developmental Origins of Suicide Mortality
Suicide Mortality
RecruitingObservational study
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
Proximal Humeral Fracture, Reverse Total Shoulder Arthroplasty
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture

All Fractures, Bone trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Prophylactic Anticoagulation on Major Bleeding Events in Hospitalized Chronic Kidney Disease and Lower Limb Fracture Patients. a Phase 2, Randomized, Doble Blind, Control Trial
ClinicalTrials.gov ID: NCT06795698
Acronym / sponsor ID: FAA / 257/18
Conditions: Fractures, Bone, CKD Stage 4, CKD Stage 3, CKD Stage 5, Enoxaparin Adverse Reaction, Anticoagulant-induced Bleeding
Keywords: chronic kidney disease, anticoagulation, bleeding, bone fracture, thrombosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Hospital Civil de GuadalajaraUniversity, hospital or other
Study start: 1 Mar 2019 (actual)
Primary completion: 1 Dec 2024 (actual)
Study completion: 1 Dec 2024 (actual)
First posted: 28 Jan 2025 (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 risk of bleeding may be greater than the benefit of antithrombotic protection when prophylactically anticoagulating a patient with a lower limb fracture and advanced CKD.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: two groups recieved anticoagulation or placebo since randomization

Arm	Type	Receives
Anticoagulation	Active comparator	Drug: EnoxaparinThe intervention drug of interest was prophylactic anticoagulation with enoxaparin 1mg/kg of ideal body weight subcutaneous every 24 hours in patients with eGFR <30ml/min/1.73m2 (REF); enoxaparin will continue till surgery, any mandatory adverse event, dead or discharge. Enoxaparin or placebo started on admission to the trial, stopped 12 hours before surgery and all patients received prophylaxis anticoagulation restarted 6 to 12 hours postoperatively according to orthopedic surgeon practices. We choose enoxaparin, a low molecular weight heparin according to the ACCP guidelines as the gold standard for VTE prophylaxis in orthopedic patients
No anticoagulation	Placebo comparator	Drug: EnoxaparinThe no anticoagulation strategy was considerate the control group, we choose as placebo a bolus of 10ml normal saline 0.9%, was prepared and administered behind a screen or curtain, and the drug was administered through normal IV tubes

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

lower limb fracture before surgery
CKD (chonic kidney disease)

Key exclusion criteria (5 listed)

<18 years old
kidney transplant
hospital stay <48 hours
had received any anticoagulant before random assignment to a patient group
had missing data that would render analysis incomplete

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
Enoxaparinenoxaparin 1mg/kg of ideal body weight subcutaneous every 24 hours in patients with eGFR <30ml/min/1.73m2	Drug	Anticoagulation, No anticoagulation

Primary outcome

Major bleeding
Time frame: From date of randomization until the date of first documented major bleeding or death from any cause, whichever came first up to 20 days. From date of randomization until surgery. Pre-intervention/procedure/surgery.
Number of Participants with Major bleeding were defined according to the International Society on Thrombosis and Haemostasis (ISTH) criteria (Schulman S). Defined as the composed event of: 1- Fatal bleeding, and/or; 2- Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or; 3- Bleeding causing a fall in hemoglobin level of 2.0 g/dL or more, or leading to transfusion of two or more units of whole blood or red cells

5 secondary outcomes

Thrombosis
Time frame: From date of randomization until the date of first documented thrombosis, or date of death from any cause, whichever came first, assessed from date of randomization until surgery up to 20 days. Pre-intervention/procedure/surgery.
Dead
Time frame: through study completion, an average of 3 weeks
number of transfusions
Time frame: From date of randomization until the date of first documented transfusions and number of transfusions. Pre-intervention/procedure/surgery.
acute kidney injury
Time frame: From date of randomization until the date of first documented acute kidney injury up to 20 days. From date of randomization until surgery. Pre-intervention/procedure/surgery.
hospitalization days
Time frame: number of days in hospital. through study completion, an average of 3 weeks

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 Jan 2025.
Background: PubMed 34133395Lieberman JR, Bell JA. Venous Thromboembolic Prophylaxis After Total Hip and Knee Arthroplasty. J Bone Joint Surg Am. 2021 Aug 18;103(16):1556-1564. doi: 10.2106/JBJS.20.02250.
Background: PubMed 24429401Naylor KL, McArthur E, Leslie WD, Fraser LA, Jamal SA, Cadarette SM, Pouget JG, Lok CE, Hodsman AB, Adachi JD, Garg AX. The three-year incidence of fracture in chronic kidney disease. Kidney Int. 2014 Oct;86(4):810-8. doi: 10.1038/ki.2013.547. Epub 2014 Jan 15.
Background: PubMed 31361316Runesson B, Trevisan M, Iseri K, Qureshi AR, Lindholm B, Barany P, Elinder CG, Carrero JJ. Fractures and their sequelae in non-dialysis-dependent chronic kidney disease: the Stockholm CREAtinine Measurement project. Nephrol Dial Transplant. 2020 Nov 1;35(11):1908-1915. doi: 10.1093/ndt/gfz142.
Background: PubMed 27145189Kim SM, Long J, Montez-Rath M, Leonard M, Chertow GM. Hip Fracture in Patients With Non-Dialysis-Requiring Chronic Kidney Disease. J Bone Miner Res. 2016 Oct;31(10):1803-1809. doi: 10.1002/jbmr.2862. Epub 2016 Jul 11.
Background: PubMed 32654892Vilaca T, Salam S, Schini M, Harnan S, Sutton A, Poku E, Allen IE, Cummings SR, Eastell R. Risks of Hip and Nonvertebral Fractures in Patients With CKD G3a-G5D: A Systematic Review and Meta-analysis. Am J Kidney Dis. 2020 Oct;76(4):521-532. doi: 10.1053/j.ajkd.2020.02.450. Epub 2020 Jul 9.
Background: PubMed 31668375Isakova T, Cai X, Lee J, Mehta R, Zhang X, Yang W, Nessel L, Anderson AH, Lo J, Porter A, Nunes JW, Negrea L, Hamm L, Horwitz E, Chen J, Scialla JJ, de Boer IH, Leonard MB, Feldman HI, Wolf M; CRIC Study Investigators. Longitudinal Evolution of Markers of Mineral Metabolism in Patients With CKD: The Chronic Renal Insufficiency Cohort (CRIC) Study. Am J Kidney Dis. 2020 Feb;75(2):235-244. doi: 10.1053/j.ajkd.2019.07.022. Epub 2019 Oct 23.
Background: PubMed 29208494Burlacu A, Genovesi S, Goldsmith D, Rossignol P, Ortiz A, Kalra PA, Malyszko J, Banach M, Kanbay M, Covic A. Bleeding in advanced CKD patients on antithrombotic medication - A critical appraisal. Pharmacol Res. 2018 Mar;129:535-543. doi: 10.1016/j.phrs.2017.12.004. Epub 2017 Dec 5.
Background: PubMed 29780621Flevas DA, Megaloikonomos PD, Dimopoulos L, Mitsiokapa E, Koulouvaris P, Mavrogenis AF. Thromboembolism prophylaxis in orthopaedics: an update. EFORT Open Rev. 2018 Apr 27;3(4):136-148. doi: 10.1302/2058-5241.3.170018. eCollection 2018 Apr.
Background: PubMed 26337134Reiss AB, Voloshyna I, De Leon J, Miyawaki N, Mattana J. Cholesterol Metabolism in CKD. Am J Kidney Dis. 2015 Dec;66(6):1071-82. doi: 10.1053/j.ajkd.2015.06.028. Epub 2015 Sep 1.
Background: PubMed 4138248Morris GK, Henry AP, Preston BJ. Prevention of deep-vein thrombosis by low-dose heparin in patients undergoing total hip replacement. Lancet. 1974 Oct 5;2(7884):797-800. doi: 10.1016/s0140-6736(74)91069-1. No abstract available.
Background: PubMed 8981880Pellegrini VD Jr, Clement D, Lush-Ehmann C, Keller GS, Evarts CM. The John Charnley Award. Natural history of thromboembolic disease after total hip arthroplasty. Clin Orthop Relat Res. 1996 Dec;(333):27-40.
Background: PubMed 12958614White RH, Zhou H, Romano PS. Incidence of symptomatic venous thromboembolism after different elective or urgent surgical procedures. Thromb Haemost. 2003 Sep;90(3):446-55. doi: 10.1160/TH03-03-0152.
Individual participant dataSharing planned: Yes. The files and data are in the physical and electronic archives of the Civil Hospital of Guadalajara Fray Antonio Alcalde and can be requested with prior authorization. All data generated or analyzed during this study are included in this article. Further inquiries can be directed to the corresponding author.

Related trials for Fractures, Bone

Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
Active, not recruitingObservational study
The Developmental Origins of Suicide Mortality
Suicide Mortality
RecruitingObservational study
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
Proximal Humeral Fracture, Reverse Total Shoulder Arthroplasty
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture

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 Phase 2 study testing Enoxaparin in people with Fractures, Bone and CKD Stage 4, run by Hospital Civil de Guadalajara 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 2 inclusion and 5 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 Jan 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 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?

Major bleeding (time frame: From date of randomization until the date of first documented major bleeding or death from any cause, whichever came first up to 20 days. From date of randomization until surgery. Pre-intervention/procedure/surgery.). 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 NCT06795698, which also lists 17 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 Jan 2025.