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Assessing serum fibrinogen and fibrin degradation products (FDP) changes in hypothermia and normothermia in patients undergoing cardiopulmonary bypass

Protocol summary

Study aim
Determine the frequency of bleeding cases by the presence or absence of coagulation disorders in two groups Determine the relationship between serum levels of fibrinogen and FDP in two groups Determine the relationship between changes in serum fibrinogen and FDP with the duration of hypothermia and normothermia Determination of the relationship between serum fibrinogen and FDP in cardiopulmonary bypass time in two groups Determination of Relationship between Serum Fibrinogen and FDP Levels with Need for Transfusion of Blood and Blood Products in ICU in Two Groups Determination of relationship between serum Fibrinogen and FDP levels with 24-hour bleeding in two groups
Design
Clinical trial, community-based, and pragmatic control group, with parallel, one-blind, randomized,
Settings and conduct
Central Hospital of Shiraz In both groups at 2 times, 2 cc of arterial blood samples were taken and placed in tubes containing tri sodium citrate. The first sample in both groups before the injection of heparin and the onset of CPB and the second sample in the hypothermic group before the onset of rewarming and in the normothermia group with the opening of the cross clamp
Participants/Inclusion and exclusion criteria
Entry requirements: Adult patients undergoing cardiac surgery No entry: All patients with history of thrombosis, bleeding, regular aspirin use in the past 5 days, congenital fibrinogen disorders, liver disease, disorders, or deficiency Coagulation factors, genetic disorders such as hemophilia, chronic renal failure patients, and people with substance abuse
Intervention groups
In the hypothermic group, the degree of water turned the heater-cooler and blanket on 30 ° C and in the noromothermia group at 35 ° C
Main outcome variables
Fibrinogen Fibrinogen degradation products Hypothermia Normothermia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180930041189N1
Registration date: 2019-02-10, 1397/11/21
Registration timing: retrospective

Last update: 2019-02-10, 1397/11/21
Update count: 0
Registration date
2019-02-10, 1397/11/21
Registrant information
Name
Motahare Ghodrati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1933
Email address
m.ghodrati87@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-07-06, 1397/04/15
Actual recruitment start date
2018-07-30, 1397/05/08
Actual recruitment end date
2018-09-06, 1397/06/15
Trial completion date
2018-11-21, 1397/08/30
Scientific title
Assessing serum fibrinogen and fibrin degradation products (FDP) changes in hypothermia and normothermia in patients undergoing cardiopulmonary bypass
Public title
Serum fibrinogen and fibrin degradation products (FDP) changes in hypothermia and normothermia in patients undergoing bypass
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All adult patients undergoing heart surgery Patients between 25 and 85 years
Exclusion criteria:
History of thrombosis bleeding regular aspirin use in the past 5 days congenital fibrinogen disorders liver disease disorders or coagulation deficiencies genetic disorders such as hemophilia chronic renal failure patients people with substance abuse
Age
From 25 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Actual sample size reached: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Permutated blocks randomization size 4
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants: After obtaining informed consent, they did not have information on which of the groups they were studying. Clinical caregivers: Clinical caregivers in the ICU did not have a patient group. Examiner Evaluation: The laboratory staff did not know which sample was for which group. Data analyzer: Descriptive data was coded and only researcher was aware of it.
Placebo
Not used
Assignment
Parallel
Other design features
Comparison of fibrinogen in two groups of hypothermia and normothermia and, in particular, fibrinogen degradation products in these two conditions in patients under the bypass

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zend Street, opposite the Palestine-Central Building
City
shiraz
Province
Fars
Postal code
71348-14336
Approval date
2018-07-29, 1397/05/07
Ethics committee reference number
IR.SUMS.REC.1397.364

Health conditions studied

1

Description of health condition studied
coronary heart disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery

Primary outcomes

1

Description
The amount of fibrinogen consumed and the production of fibrinogen degradation products
Timepoint
At the beginning of the study (before the intervention) and during the bypass in two intervals after the intervention
Method of measurement
Fibrinogen using the clauss and FDP method with serology (kit ELISA)

Secondary outcomes

1

Description
Postoperative bleeding
Timepoint
24 hours after entering ICU
Method of measurement
Measuring Chest tube bleeding

Intervention groups

1

Description
Intervention group: hyporthermic group: In this group, the temperature of the body was reduced untile 30- 34.9 ° C by a heater-cooler and a blanket (temperature changer).
Category
Treatment - Surgery

2

Description
Control group: normothermic group: Coronary artery disease is usually performed at 35- 36.5 ° C.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Central Hospital of Shiraz
Full name of responsible person
Bahram Ghasemzadeh
Street address
Central Building, opposite the Palestine, Zend Street
City
shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
m.ghodrati87@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Yuness Ghasemi
Street address
Central Building, opposite the Palestine, Zend Street
City
shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
ghasemiy@sums.ac.ir
Web page address
https://www.sums.ac.ir/
Grant name
Grant code / Reference number
1396-01-01-15084
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Bahram Ghasemzadeh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Central Building, opposite the Palestine, Zend Street
City
shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
m.ghodrati87@gmail.com
Web page address
https://www.sums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Bahram Ghasemzadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Central Building, opposite the Palestine, Zend Street
City
shiraz
Province
Fars
Postal code
71348-14336
Phone
+7 132305410
Email
m.ghodrati87@gmail.com
Web page address
https://www.sums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Bahram Ghasemzadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Central Building, opposite the Palestine, Zend Street
City
shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
m.ghodrati87@gmail.com
Web page address
https://www.sums.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Initial measurements
When the data will become available and for how long
With the publication of the paper for a month
To whom data/document is available
Persons Investigating in Cardiac Surgery field
Under which criteria data/document could be used
Use the data by naming the people of this study
From where data/document is obtainable
To request data, contact m.ghodrati@gmail.com or call 09355975983.
What processes are involved for a request to access data/document
After receiving the email and accepting the above conditions to identify the researchers, the data will be delivered to the applicant within one day.
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