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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
61
enoxaparin 1mg/kg of ideal body weight subcutaneous every 24 hours in patients with eGFR \<30ml/min/1.73m2
Hospital Civil de Guadalajara
Guadalajara, Jalisco, Mexico
Major bleeding
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
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.
Thrombosis
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
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.
Dead
Number of Participants dead
Time frame: through study completion, an average of 3 weeks
number of transfusions
Number of transfusions presurgery
Time frame: From date of randomization until the date of first documented transfusions and number of transfusions. Pre-intervention/procedure/surgery.
acute kidney injury
Number of Participants with acute kidney injury, defined as an increses in serum creatinine \>0.3mg/dL during 48 hours period
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.
hospitalization days
number of days in hospital.
Time frame: number of days in hospital. through study completion, an average of 3 weeks
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