A Phase 2 interventional study of Enoxaparin in Fractures, Bone, CKD Stage 4 and CKD Stage 3, sponsored by Hospital Civil de Guadalajara. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-28.
Sponsored by Hospital Civil de Guadalajara · Phase 2, Interventional, and Treatment
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.
2,272 studies on the registry are indexed under Fractures, Bone; 321 are open to participants now.
This study's enrollment of 61 is below the median of 68 across 1,490 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Hospital Civil de Guadalajara is the lead sponsor of 41 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
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
Drug: 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
Drug: Enoxaparin
enoxaparin 1mg/kg of ideal body weight subcutaneous every 24 hours in patients with eGFR \<30ml/min/1.73m2
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
Plan to share: Yes — The files and data are in the physical and electronic archives of the Civil Hospital of Guadalajara Fray Antonio Alcalde and can be requested with prior authorization. All data generated or analyzed during this study are included in this article. Further inquiries can be directed to the corresponding author.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: for 5 years
Access criteria: The files and data are in the physical and electronic archives of the Civil Hospital of Guadalajara Fray Antonio Alcalde and can be requested with prior authorization. All data generated or analyzed during this study are included in this article. Further inquiries can be directed to the corresponding author.
Ran from Mar 2019 to primary completion in Dec 2024, 69 months.
Of 18 phase 2 interventional studies under Fractures, Bone, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 46. This study's 69 months is above that.
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Enoxaparin
Hospital Civil de Guadalajara