E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
It is the intention with this clinical trial to evaluate wheter TachoSil may reduce the formation of postoperative haematomas on the vaginal cuff following hysterectomi. The presence of a postoperative haematoma is correlated to postoperative complications such as fever, abdomimal pain and prolonged recovery. It the incidence of haematomas may be reduced, the number of postoperative complications is expected to be reduced as well. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10044080 |
E.1.2 | Term | Total abdominal hysterectomy |
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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 |
It is the objective of this clinical trial to evaluate the efficacy and safety for haemostasis in women undergoing hysterectomy. The purpose is the gain data on the prevalence of haematomas to enable a power calculation for a randomised controlled trial. The purpose of a randomised controlled trial will be to evaluate the efficacy of TachoSil on the basis of reduction of clinically relevant haematomas at the vaginal cuff.. A clinically relevant haematoma is defined as a haematoma with postoperative clinical symptoms: Fever, abdominal pain, vaginal bleeding, transfusion, re-operation, prolonged hospital stay, prolonged reconvalesense, or any combination hereof. |
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E.2.2 | Secondary objectives of the trial |
Abdominal pain will be registered pre-operatively, at follow up after 1 week and 30 days by means of a VAS score and a QoL questionnaire in order to evaluate whether a haematoma has a clinical significance in terms of long-term postoperative abdominal pain and quality of life.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subject aged 18 or above? Informed written consent? Elective abdominal hysterectomy for on benign indication
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E.4 | Principal exclusion criteria |
History of allergic reactions after applications of human fibrinogen, human thrombin and/or collagen of any origin Participation in a clinical trial less than 30 days prior to inclusion in present trial. Participation in a clinical trial concomitantly with present trial. Intraoperative use of Cyclocapron
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of patients with haematoma at the vaginal cuff 1 week ± 2 days after surgery as assessed by ultrasound. |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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) | 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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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 | Yes |
E.8.2.3.1 | Comparator description |
Standard surgical procedure |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | Information not present in EudraCT |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |