EUCTR2018-003041-41-GB进行中（未招募）1 期
A pragmatic pilot randomised controlled trial of Prothrombin Complex Concentrate (PCC) versus Fresh Frozen Plasma (FFP) in adult patients who are undergoing Heart Surgery - PROPHESY
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age =18 years
- •- Able to give consent
- •- Any cardiovascular surgeries excluding procedures under exclusion criteria
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •A participant is not eligible if any of the following criteria are met:
- •- Unable to consent
- •- Patients refusing blood transfusion for any reason
- •- First time isolated coronary artery bypass grafts (CABG)
- •- First time isolated aortic valve replacement (excluding active endocarditis)
- •- Thoraco-abdominal surgeries
- •- Minor surgeries that do not involve cardiopulmonary bypass
- •- Use of warfarin within three days
- •- Use of direct oral anticoagulants (i.e. dabigaran, rivaroxban, apixaban or edoxaban) within 48 hrs (or 72 hours if patient has renal impairment – i.e. estimated glomerular filtration rate of <30ml/min)
- •- Inherited bleeding disorder (i.e. any inherited clotting factor deficiencies, or platelet disorders)
- •- Pregnancy
- •- Known or suspected allergy to FFP, or LG-octaplas, or PCC
- •- Known or suspected allergy to heparin, Sodium citrate dihydrate, sodium
- •dihydrogenphosphate dihydrate and Glycine
- •- History of Heparin-induced thrombocytopenia
- •- Individuals who have IgA deficiency with known antibodies against IgA
- •- Documented venous thromboembolism in the last three months
- •- Documented antiphospholipid syndrome
- •- Severe Protein S deficiency
- •- Patients who are likely to go on Extracorporeal Membrane Oxygenation (ECMO) after cardiac surgery
- •- Any other reasons the investigator may consider the patient to be ineligible for the study
- •- Participation in another clinical trial, where the patient has received IMP in the last 3 months
研究者
相似试验
已完成
不适用
Effect of acupuncture on psychosocial outcome for women experiencing infertilityInfertilityMental healthMental HealthMental healthMental Health - Other mental health disordersAlternative and Complementary Medicine - Other alternative and complementary medicineReproductive Health and Childbirth - Fertility including in vitro fertilisationInfertilityACTRN12609000288224Centre for Complementary Medicine Research (CompleMED), University of Western Sydney32
进行中（未招募）
Unknown
Asking children and young people about their general health and well being as part of routine clinical outpatient care - a pilot randomised controlled trialChildren in this study may have a range of chronic health conditions. Participating children will be from the following specialist paediatric outpatient clinics: asthma clinic, sleep clinic, encopresis clinic, and chronic constipation clinic.ISRCTN16030620Murdoch Children's Research Institute87
已完成
不适用
Study of practice pharmacist-led management of long-term paiChronic painSigns and SymptomsPainISRCTN06131530niversity of Aberdeen (UK)216
已完成
不适用
A pragmatic, randomized controlled pilot study investigating the feasbility of an international study on individualized homeopathic add-on treatment and usual care only in women with premenstrual disorderspremenstrual disorderscomplaints/symptoms occurring before menses1002794610038612NL-OMON37602ouis Bolk Instituut38
招募中
不适用
Can virtual reality help people to manage their pain after surgery? A pilot studyPost-surgical painAnaesthesiology - Pain managementSurgery - Other surgeryPhysical Medicine / Rehabilitation - Other physical medicine / rehabilitationACTRN12620000222943St Vincent's Hospital Sydney80