Investigating the effects of the simultaneous use of Voluven (hydroxyethyl starch 0.4.130) plus 20% mannitol compared to Voluven plus 3% hypertonic saline on blood coagulation using PFA-100 in patients who are candidates for surgery for supratentorial brain tumors.
Comparison of the effects of simultaneous use of Voluven and mannitol with Volvon and hypertonic saline 3% on blood coagulation using PFA-100 in patients who are candidates for surgery for supratentorial brain tumors.
Design
Clinical trial, without control group, with parallel groups, double-blind, randomized, phase 3 on 30 patients, randomization using dice rolling
Settings and conduct
After obtaining informed consent, all patients over 18 years of age who are candidates for primary surgery of supratentorial tumors referring to the operating room of the government teaching hospital are included in the study. Patients will not be included in the study if they have an uncontrollable underlying disease, diseases affecting coagulation or taking drugs affecting coagulation. In group M, mannitol is injected at the rate of 1 g/kg and over a period of 20 minutes. In group S, 3% hypertonic saline at the rate of 5 ml/kg (creating osmolality equal to mannitol) will also be injected during 20 minutes. The blood sample is sent to measure blood gases and platelet function 20 minutes after the injection of 3% mannitol and hypertonic saline solutions.
Participants/Inclusion and exclusion criteria
All patients over 18 years of age who are candidates for supratentorial tumor surgery are included in the study after obtaining informed consent. People with uncontrolled underlying diseases or diseases affecting coagulation or taking drugs affecting blood coagulation will not be included in the study.
Intervention groups
In group M, mannitol is injected at the rate of 1 g/kg and over a period of 20 minutes. In group S, 3% hypertonic saline at the rate of 5 ml/kg will also be injected during 20 minutes.
Main outcome variables
Comparison of the effects of mannitol with hypertonic saline 3% on blood coagulation using PFA-100 in patients who are candidates for surgery of supratentorial brain tumors.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210506051200N2
Registration date:2023-04-05, 1402/01/16
Registration timing:retrospective
Last update:2023-04-05, 1402/01/16
Update count:0
Registration date
2023-04-05, 1402/01/16
Registrant information
Name
Sohrab Salimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2221 2058
Email address
ssalimi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-31, 1401/10/10
Expected recruitment end date
2023-03-30, 1402/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of the simultaneous use of Voluven (hydroxyethyl starch 0.4.130) plus 20% mannitol compared to Voluven plus 3% hypertonic saline on blood coagulation using PFA-100 in patients who are candidates for surgery for supratentorial brain tumors.
Public title
Comparing the effects of mannitol and hypertonic saline on blood coagulation in brain tumor patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to study
Age above 18 years
Exclusion criteria:
Absence of heart failure
History of diseases affecting coagulation
Recent use of drugs affecting coagulation
Absence of renal failure
Absence of liver failure
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are grouped using a simple randomization method by rolling dice. In this way, if the tap comes, the S group will be selected and if the line comes, the M group will be selected.
Blinding (investigator's opinion)
Double blinded
Blinding description
Before performing anesthesia, an anesthesiologist who will not be involved in the next stages of the study will determine the patient's group using dice and the patient will receive the drug intervention according to his/her group. The anesthesiologist in charge of the patient will record the information and deliver it to the researcher in a sealed envelope.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethical commite of Shahid Beheshti University of Medical Science
Street address
Shahid Beheshti University of Medical Sciences, Shahid Arabi St., Yemen St., Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-11-04, 1397/08/13
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.621
Health conditions studied
1
Description of health condition studied
Supratentorial tumor
ICD-10 code
D43.0
ICD-10 code description
Neoplasm of uncertain behavior of brain, supratentorial
Primary outcomes
1
Description
closing time
Timepoint
Twenty minutes after drug injection in each of the two groups
Method of measurement
Using PFA100 laboratory test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the mannitol (M) group, the initial blood sample is sent before anesthesia and then after 20 minutes of mannitol injection for PFA-100 measurement.
Category
Treatment - Drugs
2
Description
Intervention group: In the hypertonic saline (S) group, the initial blood sample is sent before anesthesia and then after 20 minutes of mannitol injection for PFA-100 measurement.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان امام حسین
Full name of responsible person
سهراب سلیمی
Street address
تهران، خیابان شهید مدنی، بیمارستان امام حسین
City
تهران
Province
Tehran
Postal code
1617763141
Phone
+98 21 7756 7840
Email
ssalimi@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
University Blvd, Velenjak
City
tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 2243 9781
Email
mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?