Clinical trial NCT06795698: The Effect of Prophylactic Anticoagulation on Major Bleeding Events in Hospitalized Chronic Kidney Disease and Lower Limb Fracture Patients.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fractures, Bone
CKD Stage 4
CKD Stage 3
CKD Stage 5
Enoxaparin Adverse Reaction
Anticoagulant-induced Bleeding
Thromboses, Venous
Keywords: chronic kidney disease
anticoagulation
bleeding
bone fracture
thrombosis
Lead sponsor: Hospital Civil de Guadalajara
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups recieved anticoagulation or placebo since randomization
Primary purpose: TREATMENT

Brief 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. The secondary objectives were to assess major bleeding in patients with lower limb fractures in CKD stage 4 and 5, thrombosis, death.


Eligibility criteria: Inclusion Criteria:

* lower limb fracture before surgery
* CKD (chonic kidney disease)

Exclusion Criteria:

* \<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

Primary outcomes:
measure: Major bleeding
timeFrame: 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:
measure: Thrombosis
timeFrame: 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.
measure: Dead
timeFrame: through study completion, an average of 3 weeks
measure: number of transfusions
timeFrame: From date of randomization until the date of first documented transfusions and number of transfusions. Pre-intervention/procedure/surgery.
measure: acute kidney injury
timeFrame: 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.
measure: hospitalization days
timeFrame: number of days in hospital. through study completion, an average of 3 weeks
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara
state: Jalisco
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Krauss ES, Segal A, Dengler N, Cronin M, Pettigrew J, Simonson BG. Utilization of the Caprini Score for Risk Stratification of the Arthroplasty Patient in the Prevention of Postoperative Venous Thrombosis. Semin Thromb Hemost. 2022 Jun;48(4):407-412. doi: 10.1055/s-0042-1742739. Epub 2022 Feb 28.