Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000129189
Ethics application status
Approved
Date submitted
19/12/2018
Date registered
29/01/2019
Date last updated
29/01/2019
Date data sharing statement initially provided
29/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Bleeding Management with Noninvasive Hb Measurement in Major Surgery
Scientific title
Bleeding Management with Noninvasive Hb Measurement in Major Surgery
Secondary ID [1] 296915 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients who undergo major surgery and need transfusion 310867 0
Condition category
Condition code
Anaesthesiology 309537 309537 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Both in two groups that under go major surgery, Hb follow-up will be performed with arterial blood gas sampling which is already performed in routine procedure. In the SpHb group, Hb values obtained with continuous Hb analysis trend will be recorded till the end of surgery and also blood gas sample will be obtained in sudden falls in this trends.The amount of transfusion delivered during the postoperative intensive care unit, the Hb values at the intensive care unit and the complications during the intensive care unit will be recorded.Patients in both groups will be monitored with the M-LNCS probe, which only measures the PVI connected to the Radical-7 Pulse CO-Oximeter.In patients with SpHb group, additional SpHb values will be monitored with 2414 Hb probe (Masimo, Irvine, CA) connected to Radical-7 Pulse CO-Oximeter device.
Intervention code [1] 313187 0
Treatment: Devices
Comparator / control treatment
Group with blood transfusion treatment followed by Hb follow-up as a result of conventional intermittent blood gas sampling ,at 0-60-120-180-240-300-360 minutes following the onset of surgery and at the end of the surgeryThe amount of transfusion delivered during the postoperative intensive care unit, the Hb values at the intensive care unit and the complications during the intensive care unit will be recorded.
Control group
Active

Outcomes
Primary outcome [1] 308487 0
continuous hb measurement monitor 2414 Hb probe (Masimo, Irvine, CA) connected to Radical-7 Pulse CO-Oximeter device
Timepoint [1] 308487 0
0-60-120-180-240-300-360 following the onset of surgery and at the end of the surgery
Secondary outcome [1] 355137 0
nill
Timepoint [1] 355137 0
nill

Eligibility
Key inclusion criteria
patients undergoing major surgery, ASA I-III, 18-65 years of age, written consent will be included in the study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients undergoing emergency surgery, or patients with cardiac or vascular disease such as known heart failure or hypertension, and those who have developed surgical complications during the operation and who last longer than 10 hours will be excluded from the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SPSS 22.0 program will be used in the analyzes and mean, standard deviation, median lowest, maximum, frequency and ratio values will be used in the descriptive statistics of the data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/02/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 21139 0
Turkey
State/province [1] 21139 0
Istanbul

Funding & Sponsors
Funding source category [1] 301486 0
University
Name [1] 301486 0
Marmara University Medical School
Country [1] 301486 0
Turkey
Primary sponsor type
University
Name
Marmara University Medical School
Address
Basibüyük Mah. Maltepe Basibüyük Yolu Sok. No: 9/2 Istanbul
Country
Turkey
Secondary sponsor category [1] 301180 0
None
Name [1] 301180 0
Address [1] 301180 0
Country [1] 301180 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302230 0
Marmara University Medical School Ethics Committe
Ethics committee address [1] 302230 0
Marmara University School of Medicine Basibüyük Campus Basibüyük Mah. Maltepe Basibüyük Yolu Sok. No:9/1 Maltepe - Istanbul
Ethics committee country [1] 302230 0
Turkey
Date submitted for ethics approval [1] 302230 0
Approval date [1] 302230 0
02/02/2018
Ethics approval number [1] 302230 0
09.2018.134

Summary
Brief summary
Our primary aim in this prospective and observational study was to determine the effect of spHb monitor on perioperative blood transfusion in patients undergoing major surgery.In this study, our hypothesis is that this measurement method called SpHb, which is called continuous SpHb during major surgery, will reduce the amount of transfusion and lead to less metabolic and hemodynamic instability compared to the management based on Hb measurement by intermittent blood sampling
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89518 0
A/Prof Ayten Saracoglu
Address 89518 0
Marmara Universitesi Tip Fakultesi Hastanesi Fevzi Çakmak Mahallesi Muhsin Yazicioglu Caddesi No:11 Kaynarca Pendik
Country 89518 0
Turkey
Phone 89518 0
+905377810144
Fax 89518 0
Email 89518 0
[email protected]
Contact person for public queries
Name 89519 0
Dr Seniyye Zengin
Address 89519 0
Marmara Universitesi Tip Fakultesi Hastanesi Fevzi Çakmak Mahallesi Muhsin Yazicioglu Caddesi No:11 Kaynarca Pendik
Country 89519 0
Turkey
Phone 89519 0
+905057142443
Fax 89519 0
Email 89519 0
ulgen_t@yahoocom
Contact person for scientific queries
Name 89520 0
Dr Seniyye Zengin
Address 89520 0
Marmara Universitesi Tip Fakultesi Hastanesi Fevzi Çakmak Mahallesi Muhsin Yazicioglu Caddesi No:11 Kaynarca Pendik
Country 89520 0
Turkey
Phone 89520 0
+905057142443
Fax 89520 0
Email 89520 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.