E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients; perioperative in bariatric surgery |
patienten, peri-operatief bij bariatrische chirurgie |
|
E.1.1.1 | Medical condition in easily understood language |
anticoagulation for patients with morbidly obesity after bariatric surgery |
antistolling rondom bariatrische ingreep (overgewichtschirurgie) bij ernstig overgewicht |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
prospectieve evaluatie van de relatie tussen lean body weight en de anti-Xa activiteit van 5700 IE nadroparine 4 uur na subcutane toediening in morbide obesitas patienten na bariatrische chirurgie. |
|
E.2.2 | Secondary objectives of the trial |
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 |
bepalen van de correlatie tussen overige lichaamsmaten (BMI/ totale lichaamsgewicht) en anti-Xa activiteit
Bepalen van dosislineariteit van de anti-Xa activiteit van nadroparin in morbide obesitas |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
approval for Roux-en-Y gastric bypass
total body weight > 140 kg |
akkoord bevonden voor Roux- en - Y gastric bypass
gewicht > 140 kg |
|
E.4 | Principal exclusion criteria |
renal impairment (GFR < 30ml/min and/ or serum creatinin > 150 micromol/ml)
Coagulation disorders (APTT/PT > 2x norm)
Use of vitamin K antagonists (such as acenocoumarol)
pregnancy
|
nierinsufficientie (GFR < 30 ml/ min en/of serum kreatinine > 150 micromol/ml)
Stollingsstoornissen (APTT/PT > 2x norm)
Orale antistolling gebruik (acenocoumarol)
Zwangerschap |
|
E.5 End points |
E.5.1 | Primary end point(s) |
anti-Xa activity 4 hours after subcutaneous administration of 5700 IU nadroparin |
anti-Xa activiteit 4 uur na subcutane toediening van 5700 IE nadroparine |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
3 days and 6 weeks after surgery |
3 dagen en 6 weken na operatie |
|
E.5.2 | Secondary end point(s) |
dosage linearity of nadroparin |
dosis lineariteit van nadroparine |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
dosage linearity of nadroparin 2850 IU before surgery and nadrparin 5700 IU after surgery |
dosislineariteit van nadroparine 2850 IE voor operatie en nadroparine 5700 IE na operatie |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Observationeel |
Obeservational |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |