E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Severe postpartum bleeding |
Desuden indgår 5 personer,
der får foretaget sektio af anden årsag, som kontrol med hensyn til måling af
koagulationsparametre inden og 15 minutter efter fjernelse af placrenta. |
|
E.1.1.1 | Medical condition in easily understood language |
Severe Bleeding after delivery |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10071867 |
E.1.2 | Term | Postpartum bleeding |
E.1.2 | System Organ Class | 100000004868 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10071897 |
E.1.2 | Term | Third stage postpartum bleeding |
E.1.2 | System Organ Class | 100000004868 |
|
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 |
Through a pilot study involving 1-5 patients undergoing cesaren section for Placenta Previa to demonstrate hemostatic effect of recombinant FVIIa placed directly upon the placenta site |
Desuden indgår 5 personer,
der får foretaget sektio af anden årsag, som kontrol med hensyn til måling af
koagulationsparametre inden og 15 minutter efter fjernelse af placrenta. |
|
E.2.2 | Secondary objectives of the trial |
To study possible tromboembolic complications or adverse effects of the treatment |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with Placenta Previa |
Kontrolgruppe: 5 personer, der skal have foretaget elektivt sektio af anden årsag.
Inklusion:Patienter, der skal have foretaget elektivt sektio |
|
E.4 | Principal exclusion criteria |
Patients with allergy to NovoSeven RT or to mice; guinea pig or bovine proteins.
Patients with coagulation disorders. |
Kontrolgruppe: 5 personer, der skal have foretaget elektivt sektio af anden årsag
Eksklusion: Patienter med placenta prævia eller kendt koagulationssygdom eller allergi til NovoSeven RT. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Visualisation of hemostatic effect. Time frome start treatment to hemostase, estimates of bleeding before and after treatment, measurements of coagulation parameters and hemoglobin before and after treatment, registration of all other treatments i.e. blood products, medicamina, mechanical and surgical treatment. Number of days spent in hospital/intensive care.
|
Kontrolgruppen: Koagulationsstatus til tiden 0 og 15 min efter fjernelse af placenta |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Immediately within minutes |
Kontrolgruppen: Koagulationsstatus til tiden 0 og 15 min efter fjernelse af placenta |
|
E.5.2 | Secondary end point(s) |
Tromboembolic complications or adverse effects |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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 |
|
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.8.3 |
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
|
When effect is demonstrated or if complications occur |
|
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 | 1 |
E.8.9.1 | In the Member State concerned days | |