Comparison effects of mannitol and hypertonic saline on coagulation in vitro: a randomized, blinded trial.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000005550
• Date of registration: 07/01/2015
• Prospective Registration: Yes
• Primary sponsor: istanbul university
• 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.
• Date of first enrolment: 10/04/2015
• Target sample size: 15
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000005550.aspx
• Study type: Interventional
• Study design: Purpose: Diagnosis; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Crossover;Type of endpoint: Safety;
• Phase: Not Applicable

Countries of recruitment

Turkey

Contacts

• Name: Dr achmet ali

• Name: Dr achmet ali

Key inclusion & exclusion criteria

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
Exclusion criteria: the thromboelastometry value measured in the control sample is outside the normal values.

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Coagulation impairment depending on mannitol and hypertonic saline solution.;
Coagulation impairment depending on mannitol and hypertonic saline solution.

Blood - Clotting disorders

Anaesthesiology - Other anaesthesiology

Intervention(s)

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

Primary Outcome(s)

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.[only one measurment.]

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.[only one measurment]

Secondary Outcome(s)

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
[only one measurment. at same time with primary outcome measurment.]

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[only one measurment. at same time with primary outcome measurment.]

Secondary ID(s)

none

Source(s) of Monetary Support

Istanbul university, Istanbul medical faculty

Ethics review

Status: Approved
Approval date:
Contact:

Ethics Committee of Istanbul University, Istanbul Medical Faculty