Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-24 @ 7:46 PM
NCT ID:
NCT01046903
Eligibility Criteria:
Inclusion Criteria:
* Male or female patient, undergoing major orthopedic surgery
* At least 18 years old
Exclusion Criteria:
* Hypersensitivity to Fragmin or other low molecular weight heparins or unfractioned heparin;
* History of heparin induced thrombocytopaenia type II
* Acute gastroduodenal ulcer, cerebral haemorrhage, or other active haemorrhage.
* Serious coagulation disorder;
* Septic endocarditis;
* Injuries to and operations in the central nervous system, eye and ear within one month before orthopaedic surgery;
* Spinal or epidural anesthesia or other procedures requiring spinal puncture and concomitant treatment with high doses of dalteparin (such as those needed to treat acute deep vein thrombosis, pulmonary embolism, and Unstable coronary artery disease);
* Patients with serum creatinine level \> 150 umol/l;
* Platelet count of less than 100 000 per cubic millimeter at the beginning of the therapy;
* High probability that patient will not return to the centre for follow-up;
* Patient on oral anticoagulation therapy in the last 7 days;
* Ongoing anticoagulant therapy with other medications or non-pharmacologic therapy during the study period;
* Weight less than 40 kg;
* Simultaneous participation in another pharmacological study or receiving any investigational drug 30 days or less before surgery;
* Pregnancy or breastfeeding;
* Clinically significant hepatic dysfunction.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01046903
Study Brief:
Protocol Section:
NCT01046903