ID

35172

Descrição

The Fibrin Pad CV Phase III Study; ODM derived from: https://clinicaltrials.gov/show/NCT02040428

Link

https://clinicaltrials.gov/show/NCT02040428

Palavras-chave

Versões (1)
  1. 21/02/2019 21/02/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

21 de fevereiro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT02040428

Inglês

Eligibility Cardiovascular Disease NCT02040428

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects ≥18 years of age, requiring an elective or urgent, open aortic surgical procedure utilizing cardiopulmonary bypass. subjects in japan between ≥18 and <20 years of age will require consent by the subject's legal representative
Descrição

Age | Patient need for Aortic surgery Open approach | Cardiopulmonary Bypass | Informed Consent Patient Representative

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0877130
UMLS CUI [2,3]
C0348025
UMLS CUI [3]
C0007202
UMLS CUI [4,1]
C0021430
UMLS CUI [4,2]
C0030701
subjects must be willing to participate in the study and provide written informed consent.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
presence of an appropriate target bleeding site (tbs) along the anastomotic suture line, involving a synthetic aortic graft, as identified intra-operatively by the investigator;
Descrição

Target Bleeding Site Appropriate | Involvement Synthetic graft Aortic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0019080
UMLS CUI [1,3]
C1515974
UMLS CUI [1,4]
C1548787
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0185104
UMLS CUI [2,3]
C0003483
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products;
Descrição

Intolerance to Blood product | Intolerance to Investigational New Drugs Component | Blood product Receive Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0456388
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C1705248
UMLS CUI [3,1]
C0456388
UMLS CUI [3,2]
C1514756
UMLS CUI [3,3]
C0558080
exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or anticipated in the 60 day follow up period after surgery.
Descrição

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
female subjects who are pregnant or nursing.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
tbs is from a large defects in visible arteries or veins where the injured vascular wall requires repair and maintenance of vessel patency or where there would be persistent exposure of evarrest™ fibrin sealant patch to blood flow and/or pressure during absorption of the product;
Descrição

Target Bleeding Site | Defects Large Arteries | Defects Large Veins | Requirement Repair Vascular Patency | EVARREST Absorbable Fibrin Sealant Patch Exposure to Blood flow

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0019080
UMLS CUI [1,3]
C1515974
UMLS CUI [2,1]
C0243067
UMLS CUI [2,2]
C0549177
UMLS CUI [2,3]
C0003842
UMLS CUI [3,1]
C0243067
UMLS CUI [3,2]
C0549177
UMLS CUI [3,3]
C0042449
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C4319951
UMLS CUI [4,3]
C0042377
UMLS CUI [5,1]
C4238976
UMLS CUI [5,2]
C3896655
UMLS CUI [5,3]
C0332157
UMLS CUI [5,4]
C0232338
tbs with major arterial bleeding requiring suture or mechanical ligation;
Descrição

Target Bleeding Site | Arterial hemorrhage Major | Requirement Suture | Requirement Ligation Mechanical

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0019080
UMLS CUI [1,3]
C1515974
UMLS CUI [2,1]
C0340654
UMLS CUI [2,2]
C0205164
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0038969
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0023690
UMLS CUI [4,3]
C0443254
tbs involves an expanded polytetrafluoroethylene (eptfe) graft
Descrição

Target Bleeding Site | Involvement Expanded PTFE Graft

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0019080
UMLS CUI [1,3]
C1515974
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0015312
UMLS CUI [2,3]
C0181074
tbs within an actively infected field;
Descrição

Target Bleeding Site | Area Infected

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0019080
UMLS CUI [1,3]
C1515974
UMLS CUI [2,1]
C0205146
UMLS CUI [2,2]
C0439663
bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;
Descrição

Bleeding Site Area Bone

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0205146
UMLS CUI [1,4]
C0262950
subjects with any intra-operative findings identified by the investigator that may preclude conduct of the study procedure;
Descrição

Finding Intraoperative Excludes Completion of clinical trial

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C0456904
UMLS CUI [1,3]
C0332196
UMLS CUI [1,4]
C2732579
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Similar models

Eligibility Cardiovascular Disease NCT02040428

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age | Patient need for Aortic surgery Open approach | Cardiopulmonary Bypass | Informed Consent Patient Representative
Item
subjects ≥18 years of age, requiring an elective or urgent, open aortic surgical procedure utilizing cardiopulmonary bypass. subjects in japan between ≥18 and <20 years of age will require consent by the subject's legal representative
boolean
C0001779 (UMLS CUI [1])
C0686904 (UMLS CUI [2,1])
C0877130 (UMLS CUI [2,2])
C0348025 (UMLS CUI [2,3])
C0007202 (UMLS CUI [3])
C0021430 (UMLS CUI [4,1])
C0030701 (UMLS CUI [4,2])
Informed Consent
Item
subjects must be willing to participate in the study and provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
Target Bleeding Site Appropriate | Involvement Synthetic graft Aortic
Item
presence of an appropriate target bleeding site (tbs) along the anastomotic suture line, involving a synthetic aortic graft, as identified intra-operatively by the investigator;
boolean
C1521840 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C1548787 (UMLS CUI [1,4])
C1314939 (UMLS CUI [2,1])
C0185104 (UMLS CUI [2,2])
C0003483 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Intolerance to Blood product | Intolerance to Investigational New Drugs Component | Blood product Receive Unwilling
Item
subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products;
boolean
C1744706 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0456388 (UMLS CUI [3,1])
C1514756 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or anticipated in the 60 day follow up period after surgery.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
female subjects who are pregnant or nursing.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Target Bleeding Site | Defects Large Arteries | Defects Large Veins | Requirement Repair Vascular Patency | EVARREST Absorbable Fibrin Sealant Patch Exposure to Blood flow
Item
tbs is from a large defects in visible arteries or veins where the injured vascular wall requires repair and maintenance of vessel patency or where there would be persistent exposure of evarrest™ fibrin sealant patch to blood flow and/or pressure during absorption of the product;
boolean
C1521840 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0243067 (UMLS CUI [2,1])
C0549177 (UMLS CUI [2,2])
C0003842 (UMLS CUI [2,3])
C0243067 (UMLS CUI [3,1])
C0549177 (UMLS CUI [3,2])
C0042449 (UMLS CUI [3,3])
C1514873 (UMLS CUI [4,1])
C4319951 (UMLS CUI [4,2])
C0042377 (UMLS CUI [4,3])
C4238976 (UMLS CUI [5,1])
C3896655 (UMLS CUI [5,2])
C0332157 (UMLS CUI [5,3])
C0232338 (UMLS CUI [5,4])
Target Bleeding Site | Arterial hemorrhage Major | Requirement Suture | Requirement Ligation Mechanical
Item
tbs with major arterial bleeding requiring suture or mechanical ligation;
boolean
C1521840 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0340654 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0038969 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C0023690 (UMLS CUI [4,2])
C0443254 (UMLS CUI [4,3])
Target Bleeding Site | Involvement Expanded PTFE Graft
Item
tbs involves an expanded polytetrafluoroethylene (eptfe) graft
boolean
C1521840 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C1314939 (UMLS CUI [2,1])
C0015312 (UMLS CUI [2,2])
C0181074 (UMLS CUI [2,3])
Target Bleeding Site | Area Infected
Item
tbs within an actively infected field;
boolean
C1521840 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0205146 (UMLS CUI [2,1])
C0439663 (UMLS CUI [2,2])
Bleeding Site Area Bone
Item
bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;
boolean
C0019080 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0205146 (UMLS CUI [1,3])
C0262950 (UMLS CUI [1,4])
Finding Intraoperative Excludes Completion of clinical trial
Item
subjects with any intra-operative findings identified by the investigator that may preclude conduct of the study procedure;
boolean
C0243095 (UMLS CUI [1,1])
C0456904 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C2732579 (UMLS CUI [1,4])
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