Kidney Week

Abstract: TH-PO1116

Prophylactic Anticoagulation and Major Bleeding Events in Hospitalized Patients with CKD and Lower-Limb Fractures: A Phase 2, Randomized, Double-Blind Controlled Trial

Session Information

• CKD: Therapies, Innovations, and Insights
  November 06, 2025 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: CKD (Non-Dialysis)

• 2302 CKD (Non-Dialysis): Clinical, Outcomes, and Trials

Authors

• Chavez, Jonathan, Universidad de Guadalajara, Guadalajara, Jal., Mexico

Jonathan Chavez, PhD

• Navarro Blackaller, Guillermo, Universidad de Guadalajara, Guadalajara, Jal., Mexico

Guillermo Navarro Blackaller, MD

• Medina, Ramon, Universidad de Guadalajara, Guadalajara, Jal., Mexico

Ramon Medina, MD

• Alcantar Vallin, Maria de la Luz, Universidad de Guadalajara, Guadalajara, Jal., Mexico

Maria de la Luz Alcantar Vallin, MD

• Garcia-Garcia, Guillermo, Universidad de Guadalajara, Guadalajara, Jal., Mexico

Guillermo Garcia-Garcia, MD, FASN

• Martínez Gallardo González, Alejandro, Hospital Civil de Guadalajara, Guadalajara, Jal., Mexico

Alejandro Martínez Gallardo González

• Abundis Mora, Gabriela Jazmín, Hospital Civil de Guadalajara, Guadalajara, Jal., Mexico

Gabriela Jazmín Abundis Mora, MD

• Ornelas Ruvalcaba, Rebeca Lizette, Universidad de Guadalajara, Guadalajara, Jal., Mexico

Rebeca Lizette Ornelas Ruvalcaba, MD

• Cabrera Aguilar, Jose Said, Universidad de Guadalajara, Guadalajara, Jal., Mexico

Jose Said Cabrera Aguilar, MD

• Padilla Armas, Jorge Luis, Universidad de Guadalajara, Guadalajara, Jal., Mexico

Jorge Luis Padilla Armas

Background

During hospitalization with fractures and advanced CKD the risk of thrombosis increases, so prophylactic anticoagulation is recommended but the risk of bleeding may be greater. We aimed to assess if enoxaparin (anticoagulation) or placebo (no anticoagulation) are different in major bleeding and thrombosis.

Methods

In a phase 2 randomized controlled trial. We randomly assigned 61 patients to placebo (N=30) and anticoagulation groups (enoxaparin 40 mg; N=31). Primary outcome was the risk of major bleeding. Secondary objectives were risk of thrombosis, death, number of transfusions, dialysis requirement, hospitalization days, and the adverse events (AEs).

Results

Both groups were similar, mean age of 65 years; 54% women, eGFR 24 ml. Hip, femur and tibia fracture (45.9%, 31.1% and 23%). Major bleeding occurred in 5 (16.1%) in enoxaparin and 4 (13.3%) in placebo group. After adjusted analysis, comparing enoxaparin with placebo, no increase the risk of bleeding (OR 1.28, p = 0.741), nor was stratifying by CKD stages (p = >0.05). The frequency of thrombosis occurred in 2 (6.7%) patients in placebo and 1 (3.2%) in enoxaparin group (p = 0.61). Hospitalization days were fewer in the placebo compared to enoxaparin (14 vs 19, p = 0.023), reducing the hospital stay by 5.3 days (OR 5.31, p = 0.046). AEs gastrointestinal bleeding in 2 and 1 patient in the placebo and enoxaparin groups, respectively.

Conclusion

In advanced CKD and lower limb fracture, prophylactic anticoagulation with enoxaparin, compared with no anticoagulation, did not promote more major bleeding or prevent DVT, but prolong hospitalization by 5 days.
ClinicalTrials.gov, ID NCT06795698

Digital Object Identifier (DOI)

• doi: 10.1681/ASN.20250manqj9f