- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05148650
Impact of Balanced Crystalloid and Colloid Infusion on Haemostasis in Healthy Male Volunteers
Impact of Infusion of Balanced Crystalloid and Colloid Solutions on Haemostasis in Healthy Male Volunteers- a Randomized Controlled Crossover Trial
Study Overview
Status
Conditions
Detailed Description
Perioperative bleeding is a complication that significantly affects postoperative morbidity and quality of life and increases the patient's risk of death. Massive hemorrhage requires individualized therapy, preferably based on international recommendations. It is necessary to transfuse blood and blood products (red blood cells, freshly frozen plasma, platelets, concentrates of coagulation factors) with simultaneous rational supplementation of the intravascular space using crystalloids and colloids. Usually, these are large volumes that are infused over a short time. Proceedings in the operating room and the intensive care unit environment should stabilize the patient's general condition with the lowest possible risk of complications.
However, it has been shown that transfusions are not free from side effects. Transfusions may result not only from "classic" post-transfusion complications (allergic reactions, haemolytic reactions, infections, electrolyte disturbances) but also from iatrogenically generated disorders in the circulatory system (fluid overload), respiratory ( acute lung injury), and hemostasis (risk of hypercoagulability). It is also known that uncontrolled and unbalanced fluid therapy per se may additionally affect the haemodynamic state, haemostasis, and the immune system.
Thromboelastometry (thromboelastography) is becoming the standard of perioperative haemostasis monitoring. It has been documented that it provides more reliable data than standard laboratory tests, such as fibrinogen concentration, activated clotting time (ACT), kaolin-kephalin (aPTT), prothrombin (PT), or INR index. The test can be performed as the so-called point-of-care test (POC), which reduces the waiting time for the result and facilitates goal-directed therapy.
Little is known about the effects of fluid infusion on physiological haemostasis in healthy subjects who do not have a prior bleeding disorder and who are infused with fluids similarly to resuscitation in massive bleeding. Only singular studies in international literature attempted to answer this vital question. Still, the regular progress in the field of fluid therapy makes the obtained data less and less valuable in clinical practice.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Silesia
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Katowice, Silesia, Poland, 40-752
- Department of Anaesthesiology and Intensive Care, Faculty of Medical Sciences in Katowice, Medical University of Silesia in Katowice
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy male volunteers aged 18-30 years
- The American Society of Anaesthesiologists Physical Status (ASA PS) I risk class
- Must be able to give informed consent
Exclusion Criteria:
- Female sex
- Blood type O
- A positive history of any acute diseases in the last four weeks
- Chronic diseases
- Any diagnosed haemostatic disorders
- History of anticoagulation
- Any known bleeding diathesis
- Any pharmacotherapy in the previous week
- Participants were informed about the prohibition of drinking alcohol, excessive exercise, and stress on the day before blood sampling
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Crystalloid infusion
Intravenous (IV) transfusions were performed of a 20ml/kg of a balanced crystalloid solution (Optilyte®, Fresenius Kabi).
The infusions were performed through an intravenous cannula (18G) inserted into a vein in the antecubital fossa on the non-dominant limb at 1000 ml/h
|
Blood for coagulation tests (thromboelastometry, aPTT, PT, INR, fibrinogen concentration, D dimers) and blood morphology was collected just before and immediately after the fluid infusion. With the use of a vacuum system, 20 ml of blood was collected through an IV cannula. The first 5 ml of blood were disposed of due to the possible interference with vascular stasis and fluid infusion on the measurements results. Functional tests of coagulation were analysed through ROTEM. ROTEM coagulation analysis was carried out using a ROTEM delta analyzer (Tem Innovations GmbH, Munich, Germany), and assays were allowed to run for 60 minutes. Assays were run immediately after blood sampling to minimize a preanalytical error. Three ROTEM assays were run simultaneously, INTEM, EXTEM, and FIBTEM. |
Experimental: Colloid infusion
Intravenous (IV) transfusions were performed of a 20ml/kg of gelatin 26,500 Da (Geloplasma®, Fresenius Kabi).
The infusions were performed through an intravenous cannula (18G) inserted into a vein in the antecubital fossa on the non-dominant limb at 1000 ml/h
|
Blood for coagulation tests (thromboelastometry, aPTT, PT, INR, fibrinogen concentration, D dimers) and blood morphology was collected just before and immediately after the fluid infusion. With the use of a vacuum system, 20 ml of blood was collected through an IV cannula. The first 5 ml of blood were disposed of due to the possible interference with vascular stasis and fluid infusion on the measurements results. Functional tests of coagulation were analysed through ROTEM. ROTEM coagulation analysis was carried out using a ROTEM delta analyzer (Tem Innovations GmbH, Munich, Germany), and assays were allowed to run for 60 minutes. Assays were run immediately after blood sampling to minimize a preanalytical error. Three ROTEM assays were run simultaneously, INTEM, EXTEM, and FIBTEM. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rotational thromboelastometry (ROTEM) viscoelastic point-of-care coagulation measurements before and after balanced crystalloid infusion
Time Frame: 60 minutes
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EXTEM, INTEM, FIBTEM assays:
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60 minutes
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Rotational thromboelastometry (ROTEM) viscoelastic point-of-care coagulation measurements before and after synthetic colloid infusion
Time Frame: 60 minutes
|
EXTEM, INTEM, FIBTEM assays:
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60 minutes
|
Standard laboratory tests reporting coagulation status before and after balanced crystalloid infusion
Time Frame: 60 minutes
|
|
60 minutes
|
Standard laboratory tests reporting coagulation status before and after synthetic colloid infusion
Time Frame: 60 minutes
|
|
60 minutes
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Standard laboratory tests reporting fibrinolysis status before and after balanced crystalloid infusion
Time Frame: 60 minutes
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- D-dimer concentration (ug/ml)
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60 minutes
|
Standard laboratory tests reporting fibrinolysis status before and after synthetic colloid infusion
Time Frame: 60 minutes
|
- D-dimer concentration (ug/ml)
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60 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety outcomes after crystalloid and colloid infusion
Time Frame: 28 days
|
Assessment of safety and potential of adverse events after fluid infusion
|
28 days
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Łukasz J Krzych, Professor, Faculty of Medical Sciences in Katowice, Medical University of Silesia
- Principal Investigator: Agnieszka Wiórek, MD, Faculty of Medical Sciences in Katowice, Medical University of Silesia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KNW/0022/KB1/159/II/15161819
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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