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

Phase 2

Completed

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

• Registration Number: NCT06795698
• Lead Sponsor: Hospital Civil de Guadalajara

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01
• Study First Submitted: 2024-12-28
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-24
• Last Update Submitted: 2025-01-24
• Study First Posted: 2025-01-28
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anticoagulation	Enoxaparin	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
No anticoagulation	Enoxaparin	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

Primary Outcome Measures

Name	Time	Method
Major bleeding	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

Secondary Outcome Measures

Name	Time	Method
acute kidney injury	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.	Number of Participants with acute kidney injury, defined as an increses in serum creatinine \>0.3mg/dL during 48 hours period
hospitalization days	number of days in hospital. through study completion, an average of 3 weeks	number of days in hospital.
Thrombosis	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.	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
Dead	through study completion, an average of 3 weeks	Number of Participants dead
number of transfusions	From date of randomization until the date of first documented transfusions and number of transfusions. Pre-intervention/procedure/surgery.	Number of transfusions presurgery

Trial Locations

Locations (1)

Hospital Civil de Guadalajara; 🇲🇽 Guadalajara, Jalisco, Mexico