EUCTR2009-011603-23-IT
Active, not recruiting
Not Applicable
Evaluation of Haemostatic Efficacy, Tolerability and Safety of Kedrion Fibrin Sealant in patients undergoing major or minor Liver Surgery. Multicenter, Controlled, Open Label Randomised Phase II/III study. - KB048
KEDRIO0 sitesJune 30, 2009
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- KEDRIO
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Age \> 18 years
- •2\.Anatomical and non\-anatomical resections, whose section is \> 20 cm2
- •3\.The subjects or their authorized legal representatives must have received adequate information regarding the nature of the trial, agree on study purposes, and have signed an informed consent form approved by the Ethical Committee.
- •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
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •1\.Anatomical and non\-anatomical resections, whose section is \< 20 cm2
- •2\.Use of haemostatic agents apart from those foreseen by the study protocol
- •3\.History of congenital coagulation disorders
- •4\. Presence of any conditions which, in the investigator?s judgment, may interfere with study objective evaluation or with the patient?s participation in the study.
- •5\.Previous exposure to products containing aprotinine of bovine origin
- •6\.The patient refused to sign the written informed consent required for participation, or participated in another clinical study during the month prior to study start date (the subject received other study drugs during the last 30 days).
- •7\.Known allergies to hemoderivatives and/or to haemocomponents.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Phase 2
To stop the bleeding in cut wounds with the help of Spray prepared from plant Eraka .CTRI/2024/02/063194Parul Institute of Ayurved.
Not yet recruiting
Not Applicable
In pregnancies complicated with pre eclampsia there are various haemostatic parameters that are altered as compared to those patients whose bloodpressure readings are normal, so those parameters can be identified and pregnancies complicated with pre eclampsia can be managed before hand.Health Condition 1: O149- Unspecified pre-eclampsiaCTRI/2021/03/032267DrArchana Suneja
Completed
Not Applicable
Clinical investigation into efficacy, haemodynamics and tolerability of simvastatin versus placebo in patients with pulmonary arterial hypertensioPulmonary hypertensionCirculatory SystemOther pulmonary heart diseasesISRCTN27178415niversity Hospital Giessen (Germany)40
Completed
Not Applicable
Establishment of Hemostatic Protocol and Effectiveness of Alleviating Pain with TR band after Transradial Coronary CatheterizatioAngina PectorisJPRN-UMIN000023613St Luke's International Hospital400
Not yet recruiting
Not Applicable
Effectiveness for the shorting of hemostatic time using RDI on bleeding by biopsy forcepsulcerlative colitisJPRN-UMIN000046671Toho University Omori Medical Center Division of Gastroenterology and hepatology40