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CTRI Number  CTRI/2021/06/034500 [Registered on: 30/06/2021] Trial Registered Prospectively
Last Modified On: 12/04/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   A study to compare two medical devices during bypass in children.  
Scientific Title of Study   A Real-world, prospective, multicentre, observational, investigator-initiated study to evaluate the patient outcomes with CAPIOX FX05 integrated arterial filter oxygenator as compared to CAPIOX RX05 non- integrated arterial filter oxygenator with external arterial filter for Cardiac Surgery involving Cardiopulmonary Bypass (CPB). 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aseem R Srivastava 
Designation  Senior Director-Division of Pediatric Cardiac Surgery 
Affiliation  Artemis Hospital 
Address  Room No-1081, Ground Floor, Pediatric Cardiac Surgery Department, Artemis Hospital, Sector 51, Gurgaon, Haryana- 122001

Gurgaon
HARYANA
122001
India 
Phone  7597364480  
Fax    
Email  iitoxy.fx2021@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aseem R Srivastava 
Designation  Senior Director-Division of Pediatric Cardiac Surgery 
Affiliation  Artemis Hospital 
Address  Room No-1081, Ground Floor, Pediatric Cardiac Surgery Department, Artemis Hospital, Sector 51, Gurgaon, Haryana- 122001

Gurgaon
HARYANA
122001
India 
Phone  7597364480  
Fax    
Email  iitoxy.fx2021@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aseem R Srivastava 
Designation  Senior Director-Division of Pediatric Cardiac Surgery 
Affiliation  Artemis Hospital 
Address  Room No-1081, Ground Floor, Pediatric Cardiac Surgery Department, Artemis Hospital, Sector 51, Gurgaon, Haryana- 122001

Gurgaon
HARYANA
122001
India 
Phone  7597364480  
Fax    
Email  iitoxy.fx2021@gmail.com  
 
Source of Monetary or Material Support  
Artemis Hospital, Sector 51, Gurgaon, Haryana 122001  
 
Primary Sponsor  
Name  Artemis Hospital  
Address  Room No-1081, Ground Floor, Pediatric Cardiac Surgery Department, Artemis Hospital, Sector 51, Gurgaon, Haryana- 122001 
Type of Sponsor  Other [Private Hospital] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aseem R Srivastava  Artemis Hospital  Artemis Hospital, Sector 51, Gurgaon, Haryana 122001
Gurgaon
HARYANA 		 9873551375

iitoxy.fx2021@gmail.com 
Dr Shaunak Shah  CIMS (Care Institute of Medical Sciences)  Science City Rd, Science Panchamrut Bunglows II, Sola Ahmedabad ,Gujrat – 380060
Ahmadabad
GUJARAT 		 9825044502

cimsiitoxy.Fx2021@gmail.com 
DrDineshKrMittal  Fortis Hospital  AA-299, Shaheed Udham Singh Marg, AA Block, Poorbi Shalimar Bag, Shalimar Bagh, Delhi, 110088 
New Delhi
DELHI 		 9818434656

fortisiitoxy.Fx2021@gmail.com 
Dr Suresh Rao   Kokilaben dhirubhai ambani hospital  Department of Paediatric cardiovascular & thoracic surgery Near Kamdhenu Departmental Store Four Bungalows, Rao Saheb Achyutrao Patwardhan Marg Andheri west Mumbai-400053 Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 		 9323006588

raosureshg@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Department – Institutional Ethics Committee Artemis Hospital   Approved 
Ethics Committee of Care Institute of Medical Science   Approved 
INSTITUTIONAL ETHICS COMMITTEE Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute  Approved 
Institutional Ethics Committee of Fortis Hospital Shalimar Bagh    Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I999||Unspecified disorder of circulatory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  1.00 Month(s)
Gender  Both 
Details  Patients meeting with following criteria to be included from the study:
1) Neonates of both gender.
2) Neonates who are scheduled to undergo cardiac surgery
involving cardiopulmonary bypass with CAPIOX FX05
integrated arterial filter oxygenator.
3) Legally acceptable representatives of neonates willing
to sign an Informed Consent Form indicating that they
understand the purpose of and the procedures required
for the study and are willing to participate in the
study. 
 
ExclusionCriteria 
Details  Patients meeting with following criteria to be excluded from the study:
1) Neonates who are diagnosed with Cyanotic Heart Disease.
2) Neonates who are or will be on cardiopulmonary bypass for
more then 2 hours.
3) Presence of any other clinically significant disease or
laboratory findings that in the investigators opinion may
affect the study outcomes.
4) Participation in another study concurrently or within 4
weeks prior to the Screening visit. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
•Evaluate the Hb levels pre cardiac surgery, nadir levels
during surgery, post cardiac surgery and at time of
discharge.
•Evaluate the Haematocrit (%) levels pre cardiac surgery
and nadir levels during surgery.
•Evaluate the inflammatory response post CPB.
•Evaluate kidney function through Kidney Function Test post
CPB.
•Evaluate the platelet count pre cardiac surgery, nadir
levels during surgery, post cardiac surgery and at time
of discharge. 		 Pre, post CPB 2 hours, 24 hours and at the time of hospital discharge. 
 
Secondary Outcome  
Outcome  TimePoints 
•Priming volume used in oxygenator for the surgery (ml).
•Amount of blood/blood product transfusion required during surgery (ml).
•Incidence and Severity of Acute Kidney Injury.
•Duration of Cardiopulmonary Bypass during surgery.
•Total duration of the surgery.
•Length of ICU stay.
•Total length of stay in hospital. 		 During surgery and time of hospital stay. 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/07/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Study Title 

A Real-world, prospective, multicentre, observational, investigator-initiated study to evaluate the patient outcomes with CAPIOX FX05 integrated arterial filter oxygenator as compared to CAPIOX RX05 non- integrated arterial filter oxygenator with external arterial filter for Cardiac Surgery involving Cardiopulmonary Bypass (CPB) 

Background 

Neonatal and paediatric cardiac surgery have seen significant advancements in perfusion technology including smaller surface area disposables and lower prime, all tailored to small patient sizes. Reducing the surface area of cardiopulmonary bypass (CPB) and subsequent prime volume is especially important in neonatal patients where the volume from the CPB circuit can be the major determinant in the patient’s metabolic response to the cardiac operation. 

Attempts by perfusionists to decrease the circuit prime volume by even a few millilitres can result in a reduction of exogenous blood products. Perfusionists have continuously looked at methods to further reduce CPB prime volumes and often find themselves balancing this goal while maintaining safety. 

Despite many advances, CPB for infants continues to have the potential to produce significant morbidity and mortality. With its pro-inflammatory effects, CPB adversely affects several organ systems. There continues to be significant gaps in our knowledge of how to decrease these effects. Continual investigation of modifications to the bypass circuit itself has the potential to decrease inflammation, improve organ function, and ultimately improve morbidity in this patient group. 

Selection of individual components in particular type of bypass circuit design can dramatically change the clinical outcome of a patient. Considerable improvement in performance can be notice with significant modifications in Oxygenators. The use of one oxygenator versus another oxygenator continues to be debated in many institutions and within the perfusion community. 

The purpose of this Real-world, prospective, observational study is to evaluate the patient outcomes with CAPIOX FX05 integrated arterial filter oxygenator as compared to CAPIOX RX05 non- integrated arterial filter oxygenator with external arterial filter for Cardiac Surgery involving Cardiopulmonary Bypass (CPB). 

Study Objective 

To evaluate oxygenator usage associated outcomes in neonates undergoing CPB during cardiac surgery with CAPIOX FX05 integrated arterial filter oxygenator as compared to CAPIOX RX05 non- integrated arterial filter oxygenator with external arterial filter 

Study Design 

Real world, prospective, multicenter, observational, comparative, investigator-initiated study 

Study Phase 

Real-World Observational study 

Study Sites 

  1. Artemis Hospital, Gurgaon 

  1. Fortis Hospital, Shalimar bagh, New Delhi 

  1. Sir Gangaram Hospital, New Delhi 

  1. CIMS Hospital, Ahmedabad 

Sample size 

As such this is a real-world observational study the prospective data on as many patients as possible from whom informed consent has been obtained will be included in the study for the CAPIOX FX05 integrated arterial filter oxygenator and CAPIOX RX05 non- integrated arterial filter oxygenator with external arterial filter for a period of 6 months from the date of initiation of study at site. 

Study Patients 

Inclusion Criteria: 

Patients meeting with following criteria to be included in the study: 

  • Neonates of both gender. 

  • Neonates who are scheduled to undergo cardiac surgery involving cardiopulmonary bypass with CAPIOX FX05 (1CX*FX05RW) integrated arterial filter oxygenator. 

  • Neonates who are scheduled to undergo cardiac surgery involving cardiopulmonary bypass with CAPIOX RX05 (CX*RX05RW) non- integrated arterial filter oxygenator with external arterial filter. 

  • Legally acceptable representatives of neonates willing to sign an Informed Consent Form indicating that they understand the purpose of and the procedures required for the study and are willing to participate in the study. 

 

Exclusion Criteria: 

Patients meeting with following criteria to be excluded from the study: 

  • Neonates who are diagnosed with Cyanotic Heart Disease 

  • Neonates who are or will be on cardiopulmonary bypass for ≥ 2 hours.  

  • Presence of any other clinically significant disease or laboratory findings that in the Investigator’s opinion may affect the study outcomes. 

  • Participation in another study concurrently or within 4 weeks prior to the Screening Visit. 

Study Devices 

  • CAPIOX FX05 (1CX*FX05RW) integrated arterial filter oxygenator. 

  • CAPIOX RX05 (CX*RX05RW) non- integrated arterial filter oxygenator with external arterial filter. 

Study Follow-up Duration 

Once enrolled into the study the patient’s will be followed-up until they are discharged from the Intensive Care Unit (ICU). 

Study Timelines 

Documentation & Submission – Dec 2020 to Jan 2021 

Approvals & Setup – Jan 2021 to March 2021 

Patient accrual – April 2021 to Sept 2021 

Data collection & analysis – Sept 2021 to Oct 2021 

Study report – Nov 2021 

Primary Outcome 

  • Evaluate the Haemoglobin (gm/dL) levels pre cardiac surgery, nadir levels during surgery, post cardiac surgery and at time of discharge. 

  • Evaluate the Haematocrit (%) levels pre cardiac surgery and nadir levels during surgery.  

  • Evaluate the inflammatory response post CPB. 

  • Evaluate kidney function through Kidney Function Test post CPB. 

  • Evaluate the platelet count pre cardiac surgery, nadir levels during surgery, post cardiac surgery and at time of discharge. 

Secondary Outcomes 

  • Priming volume used in oxygenator for the surgery (ml). 

  • Amount of blood/blood product transfusion required during surgery (ml). 

  • Incidence and Severity of Acute Kidney Injury. 

  • Duration of Cardiopulmonary Bypass during surgery. 

  • Total duration of the surgery. 

  • Length of ICU stay. 

  • Total length of stay in hospital. 

Safety Outcomes 

  • Adverse events (AE) or serious adverse events (SAE), noticed by the surgeon/perfusionist will be recorded during the study. 

  • Surgery procedure related complications.  

  • Mortality rate. 

 
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