Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000005550
Ethics application status
Approved
Date submitted
17/11/2014
Date registered
7/01/2015
Date last updated
18/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison effects of mannitol and hypertonic saline on coagulation in vitro: a randomized, blinded trial.
Scientific title
Comparison effects of 20 % mannitol and 3 % hypertonic saline on coagulation in vitro in healthy volunteers: a randomized, blinded trial.
Secondary ID [1] 284757 0
none
Universal Trial Number (UTN)
U1111-1157-7838
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coagulation impairment depending on mannitol and hypertonic saline solution. 292125 0
Condition category
Condition code
Blood 292458 292458 0 0
Clotting disorders
Anaesthesiology 292459 292459 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will take 20 ml blood ( 5 tube of 4ml) an antecubital vein from healthy volunteers for study.. Four ml blood sample was seperated for each group. In each group 2 ml blood were collected into polypropylene tubes (Vacuette, Greiner Bio-one, Austria) containing 3.2% buffered citrate, giving a volume ratio of 1:10 for ROTEM analysis and 2 ml blood were collected into EDTA tubes containing 1.2 mg anhydrous EDTA per 1ml blood (Vacuette, Greiner Bio-one, Austria) for hemogram analysis.Immediately after sampling all blood samples were diluted with the test solutions.Thereafter, within 2 hours after blood withdrawal, thromboelastometry coagulation analysis (ROTEM; Pentapharm Co., Munich, Germany) was made in random order for all samples. The coagulation process will initiate by recalcification (Star-TEM; Pentapharm Co., Munich,Germany) and activation with tissue factor EXTEM and INTEM for monitoring the extrinsic system, and intrinsec system . In the FIBTEM assay (fib-TEM, Pentapharm Co.) a plateletinhibitor (GPIIb/IIIa platelet receptor antagonist abciximab) together with cytochalasin D was added to assess the contribution of fibrinogen to clot strength, and EXTEM analysis was carried out. Automatically measured thromboelastometry parameters of blood coagulation will be recorded. This parameters are Clotting time (CT), Clot formation time (CFT) and Maximum clot firmness (MCF). (We will record each CT,CFT and MCF measurements at INTEM, EXTEM and FIBTEM) We also will record hemoglobin and platelet value of each sample.
In present study there are five arm.
Arm 1: Control group. Sample contain 2 ml pure blood. We will make thromboelastometry coagulation analysis this sample.
Arm 2 : 7% Mannitol group. Sample contain: 1.86ml blood and 0.14 ml 20% mannitol. We will make thromboelastometry coagulation analysis this sample.

Arm 3: 7% hypertonic saline group. Sample contain 1.86 ml blood and 0.14 ml 3%NACL. We will make thromboelastometry coagulation analysis this sample.

Arm 4: 6% Mannitol - 8%HES group. Sample contain 1.72 ml blood, 0.12 ml 20% mannitol and 0.16 ml Hydroxyethyl Starch 130/0.4. We will make thromboelastometry coagulation analysis this sample.

Arm 5: 6% Hypertonic saline - 8%HES group. contain 1.72 ml blood, 0.12 ml 3%NACL and 0.16 ml Hydroxyethyl Starch 130/0.4. We will make thromboelastometry coagulation analysis this sample.
Intervention code [1] 289548 0
Diagnosis / Prognosis
Intervention code [2] 289549 0
Treatment: Other
Comparator / control treatment
Sample contain 2 ml pure blood. We will make thromboelastometry coagulation analysis this sample.
Control group
Active

Outcomes
Primary outcome [1] 292321 0
We will create an experimental in vitro model to comparison effects of 20% mannitol and 3% hypertonic saline on Maximum clot firmness (MCF) values that measured by thromboelastogram.
Timepoint [1] 292321 0
only one measurment.
Primary outcome [2] 293750 0
We will create an experimental in vitro model to comparison effects of 20% mannitol and 3% hypertonic saline on Clotting time (CT) and Clot formation time (CFT) values that measured by thromboelastogram.
Timepoint [2] 293750 0
only one measurment
Secondary outcome [1] 308715 0
We will create an experimental in vitro model to determine adding HES 130/0.4 solusion has any additional effects on Maximum clot firmness (MCF) values that measured by thromboelastogram
Timepoint [1] 308715 0
only one measurment. at same time with primary outcome measurment.
Secondary outcome [2] 311751 0
We will create an experimental in vitro model to determine adding HES 130/0.4 solusion has any additional effects on Clotting time (CT) and Clot formation time (CFT) values that measured by thromboelastogram
Timepoint [2] 311751 0
only one measurment. at same time with primary outcome measurment.

Eligibility
Key inclusion criteria
1-Aged 18 - to 65 years old
2- no bleeding diathesis.
3-no liver failure.
4- no renal failure.
5-No blood transfusion within 1 month.
6- No any medication within 1 month.
7- normal hemoglobin and platelet values
8- No alcohol use within 1 week
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
the thromboelastometry value measured in the control sample is outside the normal values.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
First researcher will take blood and prepare five diffrent sample for gorups.
Second researcher will determine samples measurement sequence randomly using the closed envelope method.
Third researher will be made measurment and record result.
Second and third researcher will not know which of the samples belonging to the which group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Our primer out came values is MCF that measured by thromboelastogram.Because previous studies showed that most affected measurement is MCF.Sample size was calculated according to this.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/02/2015
Actual
10/04/2015
Date of last participant enrolment
Anticipated
Actual
5/06/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
15
Recruitment outside Australia
Country [1] 6104 0
Turkey
State/province [1] 6104 0
istanbul

Funding & Sponsors
Funding source category [1] 289373 0
University
Name [1] 289373 0
Istanbul university, Istanbul medical faculty
Country [1] 289373 0
Turkey
Primary sponsor type
University
Name
istanbul university
Address
istanbul medical faculty,Department of Anesthesiology ,turgut ozal cad. no: 12, fatih istanbul
post code:34093
Country
Turkey
Secondary sponsor category [1] 288057 0
None
Name [1] 288057 0
Address [1] 288057 0
Country [1] 288057 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291959 0
Ethics Committee of Istanbul University, Istanbul Medical Faculty
Ethics committee address [1] 291959 0
istanbul universitesi istanbul tip fakultesi etik kurulu turgut ozal cad no:12 dekanlik binasi fatih istanbul
post code:34093
Ethics committee country [1] 291959 0
Turkey
Date submitted for ethics approval [1] 291959 0
20/10/2014
Approval date [1] 291959 0
24/10/2014
Ethics approval number [1] 291959 0
2014/1619

Summary
Brief summary
Twenty ml blood samples were obtained from an antecubital vein using an 18 G venous cannula (VasofixTM, B. Braun, Melsungen, Germany) from each participant. Four ml blood sample was seperated for each group. In each group 2 ml blood were collected into polypropylene tubes (Vacuette, Greiner Bio-one, Austria) containing 3.2% buffered citrate, giving a volume ratio of 1:10 for ROTEM analysis and 2 ml blood were collected into EDTA tubes containing 1.2 mg anhydrous EDTA per 1ml blood (Vacuette, Greiner Bio-one, Austria) for hemogram analysis. Sensitive electronic pipette was used for make mixtures. Immediately after sampling all blood samples were diluted with the test solutions.
Thereafter, within 1 hours after blood withdrawal, thromboelastometry coagulation analysis will made in random order from the diluted samples and a control of undiluted blood. Automatically measured thromboelastometry parameters of blood coagulation will be recorded. This parameters are Clotting time (CT), Clot formation time (CFT) and Maximum clot firmness (MCF). (We will record each CT,CFT and MCF measurements at INTEM, EXTEM and FIBTEM) We also will record hemoglobin and platelet value of each sample.
In present study there are five arm.
Arm 1: Control group.
Arm 2 : 7% Mannitol group.
Arm 3: 7% hypertonic saline group.
Arm 4: 6% Mannitol - 8%HES group.
Arm 5: 6% Hypertonic saline - 8%HES group.
Trial website
Trial related presentations / publications
Study was completed..There is no trial-related citations
Public notes

Contacts
Principal investigator
Name 49054 0
Dr achmet ali
Address 49054 0
Istanbul medical faculty, departman of anesthesiology turgut ozal cad.no:12 fatih istanbul
post code:34093
Country 49054 0
Turkey
Phone 49054 0
+905424878264
Fax 49054 0
Email 49054 0
[email protected]
Contact person for public queries
Name 49055 0
Dr achmet ali
Address 49055 0
Istanbul medical faculty, departman of anesthesiology turgut ozal cad.no:12 fatih istanbul
post code:34093
Country 49055 0
Turkey
Phone 49055 0
+905424878264
Fax 49055 0
Email 49055 0
[email protected]
Contact person for scientific queries
Name 49056 0
Dr achmet ali
Address 49056 0
Istanbul medical faculty, departman of anesthesiology turgut ozal cad.no:12 fatih istanbul
post code:34093
Country 49056 0
Turkey
Phone 49056 0
+905424878264
Fax 49056 0
Email 49056 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
Dimensions AIA Comparison of the Effects of 20% Mannitol and 3% NaCl on Coagulation Parameters In Vitro using ROTEM: A Prospective Randomized Crossover Study2017https://doi.org/10.5152/tjar.2017.74875
N.B. These documents automatically identified may not have been verified by the study sponsor.