Anticoagulant-induced Bleeding, CKD Stage 3, CKD Stage 4, CKD Stage 5, Enoxaparin Adverse Reaction, Fractures, Bone, Thromboses, Venous
Conditions
Keywords
chronic kidney disease, anticoagulation, bleeding, bone fracture, thrombosis
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.
Interventions
DRUGEnoxaparin
enoxaparin 1mg/kg of ideal body weight subcutaneous every 24 hours in patients with eGFR \<30ml/min/1.73m2
Sponsors
Hospital Civil de Guadalajara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Blinding was achieved by shielding the patients from seeing the preparation of the study drug and having unblinded study personnel not involved in any study outcome assessments responsible for preparing and administering the study treatment.
Intervention model description
two groups recieved anticoagulation or placebo since randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
Mexico
Outcome results
None listed