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

Hospital Civil de Guadalajara

Status and phase: Completed; Phase 2

Conditions: Thromboses, Venous; CKD Stage 5; Enoxaparin Adverse Reaction; CKD Stage 3; Anticoagulant-induced Bleeding; CKD Stage 4; Fractures, Bone

Treatments: Drug: Enoxaparin

Study type: Interventional

Funder types: Other

Identifiers

NCT06795698

257/18

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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61 participants in 2 patient groups, including a placebo group

Anticoagulation

Active Comparator group

Description:

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

Treatment:

Drug: Enoxaparin

No anticoagulation

Placebo Comparator group

Description:

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

Treatment:

Drug: Enoxaparin