Recombinant Factor VIIa: Local treament of severe bleedings after delivery

Phase 1

Conditions: Severe postpartum bleeding
MedDRA version: 16.1Level: LLTClassification code 10071867Term: Postpartum bleedingSystem Organ Class: 100000004868
MedDRA version: 16.1Level: LLTClassification code 10071897Term: Third stage postpartum bleedingSystem Organ Class: 100000004868
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2013-005036-20-DK

Lead Sponsor: Stellaris Pharmaceuticals ApS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

Patients with Placenta Previa
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 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with allergy to NovoSeven RT or to mice; guinea pig or bovine proteins.
Patients with coagulation disorders.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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;Secondary Objective: To study possible tromboembolic complications or adverse effects of the treatment;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. <br>;Timepoint(s) of evaluation of this end point: Immediately within minutes

Secondary Outcome Measures