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Profylaxis of venous thromboembolism after bariatric surgery.

Prospective, pharmacokinetic study for determination of the relationship between lean body weight and anti-Xa activity 4 hours after subcutaneous injection of 5700 IU nadroparin in morbidly obese patients after bariatric surgery. - Nadroparin and anti-Xa actitivity after bariatric surgery

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-002816-19-NL
Enrollment
Unknown
Registered
2012-07-03
Start date
2012-10-25
Completion date
Unknown
Last updated
2012-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients

Interventions

Trade Name: Fraxiparine Product Name: Fraxiparine Pharmaceutical Form: Solution for injection in pre-filled syringe

Sponsors

Rijnstate Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: approval for Roux-en-Y gastric bypass total body weight > 140 kg Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: renal impairment (GFR 150 micromol/ml) Coagulation disorders (APTT/PT > 2x norm) Use of vitamin K antagonists (such as acenocoumarol) pregnancy

Design outcomes

Primary

MeasureTime frame
Secondary Objective: Correlation between other body parameters (such as BMI/ total body weight ) and anti-Xa activity Determination of dosage linearity of anti-Xa activity of nadroparin in morbid obese patients;Primary end point(s): anti-Xa activity 4 hours after subcutaneous administration of 5700 IU nadroparin;Timepoint(s) of evaluation of this end point: 3 days and 6 weeks after surgery;Main Objective: prospective evaluation of the ralationship between lean body weight and anti-Xa activity and 5700 IE nadroparin 4 hours after subcutaneous administration in morbidly obese patients after bariatric surgery—

Secondary

MeasureTime frame
Secondary end point(s): dosage linearity of nadroparin;Timepoint(s) of evaluation of this end point: dosage linearity of nadroparin 2850 IU before surgery and nadrparin 5700 IU after surgery—

Countries

Netherlands

Contacts

Public ContactK. Dogan

Rijnstate Hospita;

kdogan@rijnstate.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026