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OpenTrials
Completed

NCT Number: NCT06795698

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

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.

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Key information

Conditions

Fractures, Bone Anticoagulant-induced Bleeding CKD Stage 3 CKD Stage 4 CKD Stage 5 Cardiovascular Diseases Chronic Disease Disease Attributes Embolism and Thrombosis Enoxaparin Adverse Reaction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemorrhage Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Thromboses, Venous Thrombosis Urogenital Diseases Urologic Diseases Vascular Diseases Venous Thrombosis Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Civil de Guadalajara

Guadalajara, Jalisco, 44240, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enoxaparin

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

    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

  2. Dead

    Time frame: through study completion, an average of 3 weeks

    Number of Participants dead

  3. number of transfusions

    Time frame: From date of randomization until the date of first documented transfusions and number of transfusions. Pre-intervention/procedure/surgery.

    Number of transfusions presurgery

  4. 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.

    Number of Participants with acute kidney injury, defined as an increses in serum creatinine >0.3mg/dL during 48 hours period

  5. hospitalization days

    Time frame: number of days in hospital. through study completion, an average of 3 weeks

    number of days in hospital.

Sponsors and collaborators

Lead sponsor

Hospital Civil de Guadalajara

Other

Registry information

Official study 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

Acronym: FAA

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jan 28, 2025
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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