EUCTR2016-003661-26-HR
Active, not recruiting
Phase 1
A controlled, randomized, multi-centre, double blind, phase II study to evaluate efficacy and safety of topical PeproStat in intraoperative surgical haemostasis - CLOTFAST 2
ConditionsTo achieve haemostasis when bleeding cannot be controlled by conventional methods alone, such as manual pressure, cauterization, or suturesor are inappropriate.MedDRA version: 20.0Level: LLTClassification code 10053001Term: Surgical haemostasisSystem Organ Class: 100000004865Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- To achieve haemostasis when bleeding cannot be controlled by conventional methods alone, such as manual pressure, cauterization, or sutures
- Sponsor
- Haemostatix Ltd
- Enrollment
- 300
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Subject is undergoing a planned open liver/soft tissue surgery, vascular surgery or spine surgery.
- •2\.Subjects are able and willing to provide written informed consent to participate in this study.
- •3\.Adult males and females \=18 years of age at screening.
- •4\.Willing and able to comply with all protocol requirements including follow\-up assessments.
- •5\.Male subjects must be willing and able to use adequate contraception from enrollment through to the 30 day follow\-up visit.
- •6\.Women of childbearing potential (WCBP) have to use highly effective methods of contraception from enrollment through to the 30 day follow\-up visit. Such methods include:
- •Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal or transdermal.
- •Progestogen\-only hormonal contraception associated with inhibition of
- •ovulation: oral, injectable or implantable.
- •Intrauterine device (IUD), intrauterine hormone\-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence
Exclusion Criteria
- •1\.Subject is undergoing emergency surgical procedure.
- •2\.Use of study treatment and sponge in
- •Closure of skin incisions as the sponge may interfere with the healing of skin edges.
- •Intravascular compartments because of the risk of embolization following sponge application.
- •3\.Recipient of an organ transplant.
- •4\.Haematologic, biochemistry and coagulation panel thresholds at screening:
- •Haemoglobin \= 9\.0 g/dL.
- •Platelet count \=100,000/mm3 (\= 100 x 109/L).
- •International Normalized Ratio (INR) \> 2\.0 or aPTT ratio \> 2\.0\.
- •Fibrinogen level \< 1\.5 g/L.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A study to evaluate the effectiveness and safety of study drug (PeproStat) to stop bleeding during surgery.To achieve haemostasis when bleeding cannot be controlled by conventional methods alone, such as manual pressure, cauterization, or suturesor are inappropriate.MedDRA version: 19.0 Level: LLT Classification code 10053001 Term: Surgical haemostasis System Organ Class: 100000004865Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]EUCTR2016-003661-26-GBHaemostatix Ltd214
Active, not recruiting
Phase 1
A study to evaluate the effectiveness and safety of study drug (PeproStat) to stop bleeding during surgery.To achieve haemostasis when bleeding cannot be controlled by conventional methods alone, such as manual pressure, cauterization, or suturesor are inappropriate.MedDRA version: 20.0Level: LLTClassification code 10053001Term: Surgical haemostasisSystem Organ Class: 100000072483Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]EUCTR2016-003661-26-PLHaemostatix Ltd300
Recruiting
Not Applicable
A multi-center, randomized, controlled, double-blind clinical study on the treatment of Chronic kidney disease with Kidney-Yang deficiency syndrome by Wenshenyang prescriptioITMCTR2100004410Beijing University of Chinese Medicine
Active, not recruiting
Phase 1
A multicenter, randomised, controlled, double-blind study to evaluate efficacy and safety of a perennial sublingual specific immunotherapy with a solution of grass pollen allergen extract in children with clinically relevant grass pollen sensitivity in comparison to a symptomatic standard treatment with add on placeboIgE-mediated allergic disease manifested as symptoms of allergic rhinitis/rhinoconjunctivitis with or without allergic bronchial asthma (GINA I and II), triggered by grass pollen allergens.MedDRA version: 9.1Level: LLTClassification code 10036019Term: Pollen allergyEUCTR2006-005911-82-PLAllergopharma Joachim Ganzer KG230
Completed
Not Applicable
Anakinra in the treatment of acute calcium pyrophosphate arthritisISRCTN46471047niversity Hospital Centre and University of Lausanne (CHUV) (Switzerland)-Service of Rheumatology75