Effect of prophylactic administration of fibrinogen concentrate on volume of transfused packed RBC during and after totla hip arthroplasty in sina hospital during 2011-2012.
According to limitations and costs of preparation and transfusion of blood products,to prevent eaely transfusion of PRBC and consequences adverse effects,by prophylactic administration of fibrinogen concentrate we provide a good level of seum fibrinogen, that is the first procoagulant decreseanig during hemorrhage, to evaluate volume of blood loss and need for packed RBC transfusion.the patients fulfill the inclusion criteria randomized into 2 groups receiving 30 mg/kg fibrinogen concentrate or equivalent volume of normal saline after induction of anesthesia.blood loss and volume of PRBC and probabale consequent reactions would be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012264784N2
Registration date:2012-06-11, 1391/03/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-06-11, 1391/03/22
Registrant information
Name
Reza Shariat Moharari
Name of organization / entity
Sina hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 8825 6883
Email address
moharari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Terhan University of Medical Sciencs
Expected recruitment start date
2011-04-21, 1390/02/01
Expected recruitment end date
2012-06-21, 1391/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of prophylactic administration of fibrinogen concentrate on volume of transfused packed RBC during and after totla hip arthroplasty in sina hospital during 2011-2012.
Public title
Effect of prophylactic administration of fibrinogen concentrate on volume of transfused packed RBC during and after totla hip arthroplasty.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1- patients aged 35-75 years old scheduled for total hip arthroplasty
2-ASA physical status I and II
3-hemoglubin level more than 10
4-MET more than 4
5-completely fill and sign the informed consent.
Exclusion criteria:
1-ASA class more than 3
2-MET<4
3-pregnancy
4-history of allergic reaction to blood products specially fibrinogen concentrate
5-history of DVT and pulmunary emboli and any embolic events.
6-recent MI and CVA during last 6 month
7-known cases of coagulopathy and thrombocytopenia.
Age
From 35 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
committee of ethics in research-Tehran University of Medical Sciences
Street address
keshavarz Blv- edge of qods St-6 th floor -central organisation of TUMS
City
tehran
Postal code
1417653761
Approval date
2011-07-28, 1390/05/06
Ethics committee reference number
90/د/130/662
2
Ethics committee
Name of ethics committee
TUMS committe of ethics in research
Street address
keshavarz Blv- edge of qods St-central organisation of TUMS
City
tehran
Postal code
1417653761
Approval date
2011-07-28, 1390/05/06
Ethics committee reference number
90/D/130/662
Health conditions studied
1
Description of health condition studied
totla hip arthroplasy
ICD-10 code
Z96.6
ICD-10 code description
Hip-joint replacement (partial)(total)
Primary outcomes
1
Description
volume of transfused packed RBC during and after totla hip arthroplasty surgery
Timepoint
any time during and after surgery that needs transfusion
Method of measurement
in mili liter
2
Description
volume of bleeding during and after totla hip arthroplasty surgery
Timepoint
during and after surgery
Method of measurement
calculating number of gauzes and longauze and suction fluid in mililiter
3
Description
level of hemoglobin during and after surgery
Timepoint
during and 24 hour after surgery
Method of measurement
check of hemoglobin level in perioperative period by CBC test
4
Description
complications of transfusion
Timepoint
during and after surgery
Method of measurement
subjective if the patient is awakw and objective if the patient is anesthesized
Secondary outcomes
1
Description
volume of transfused other blood products
Timepoint
during and after surgery
Method of measurement
as mililiter or unit of transfused product
2
Description
thromboembolic events
Timepoint
during hospitalisation and after discharge up to 2 weeks(according to fibrinogen half life)
Method of measurement
by post operative visit and examination, phone follow up until 2 weeks after discharge
3
Description
transfusion related long term complication
Timepoint
long term after surgery
Method of measurement
subjective by patient declarement or complain or objective by take history and physical exam and labratory tests if needed
4
Description
cardiovascular complications due to bleeding
Timepoint
during and after surgery
Method of measurement
ECG monitoring and 12 lead ECG trace record during aneshtesia ,history and physical exam after surgery
Intervention groups
1
Description
In case group after induction of anesthesia we infuse 30mg/kg fibrinogen concentrtate IV in 15 minutes.before infusion by means of arterial catheter blood sampling perform and check it for serum level of fibrinogen in both groups( for baseline).during surgery with 30 minute intervals mean atreial pressure would be registered.blood loss is estimated by means of caclculating number of guazes an longuazes and suction container.each guaze and longuaze consist of 20 and 50 ml respectively.maximum allowable blood loss would be calculated by this equationABL=65 X body weightX(patient Hb - desired Hb for sex an age)/optimal Hb.volume of packed RBC contains about 250 ml RBC which would be diluted with 250 ml warm normal saline and transfused for compensation of blood loss.during surgery with warm crystaloids and warm forced air and thermal monitoring maintaining normothermia.monitoring of acid base would be performed.
Category
Prevention
2
Description
In control(placebo) group after induction of anesthesia we infuse normal saline in equivalent volume of fibrinogen.before infusion by means of arterial catheter blood sampling perform and check it for serum level of fibrinogen in both groups( for baseline).during surgery with 30 minute intervals mean atreial pressure would be registered.blood loss is estimated by means of caclculating number of guazes an longuazes and suction container.each guaze and longuaze consist of 20 and 50 ml respectively.maximum allowable blood loss would be calculated by this equationABL=65 X body weightX(patient Hb - desired Hb for sex an age)/optimal Hb.volume of packed RBC contains about 250 ml RBC which would be diluted with 250 ml warm normal saline and transfused for compensation of blood loss.during surgery with warm crystaloids and warm forced air and thermal monitoring maintaining normothermia.monitoring of acid base would be performed.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of Medical Sciences-SINA hospital
Full name of responsible person
Dr.Reza Shariat Moharari
Street address
Sina hospital, Imam Khomeini street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Siences- Vice-chancellor for reseach
Full name of responsible person
Dr.Akbar Fotouhi
Street address
Sixth Floor,Tehran University of Medical Siences, Ghods street, Keshavarz blv.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Siences- Vice-chancellor for reseach
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
sina hospital-tehran university of medical sciences
Full name of responsible person
Dr.Reza shariat Moharari
Position
associated professor of department of anesthesia and critical care
Other areas of specialty/work
Street address
emam khomeini street-sina hospital
City
tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
Email
moharari@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
associated professor-department of anesthesia and critical care-sina hospital TUMS
Full name of responsible person
Dr.Atabak Nadjafi
Position
associated professor of department of anesthesia and critical care
Other areas of specialty/work
Street address
emam khomeini street- sina hospital
City
tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
Email
nadjafia@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
department of anesthesia and critical care-sina hospital-TUMS
Full name of responsible person
Dr.Reza Shariat Moharari
Position
associated professor -department of anesthesia and critical care-TUMS
Other areas of specialty/work
Street address
emam khomeini street-sina hospital
City
tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)