Perioperative HemorrhageNCT05148650
Impact of Balanced Crystalloid and Colloid Infusion on Haemostasis in Healthy Male Volunteers
A study testing Standard laboratory coagulation tests and rotational thromboelastometry measurements in people with Perioperative Hemorrhage and Dilutional Coagulopathy, run by Medical University of Silesia at 1 site in Poland.
Trial summary
The project focuses on perioperative bleeding that requires transfusion of blood products and supplementation of intravascular volume with crystalloids and colloids. The implemented fluid therapy affects coagulation and fibrinolysis, depending on the type of fluid used in an intravenous infusion. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Perioperative Hemorrhage, Dilutional Coagulopathy
- What is being tested?
- Standard laboratory coagulation tests and rotational thromboelastometry measurements
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 sitePoland
- Study dates
- 16 Feb 2021to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Anaesthesiology and Intensive Care, Faculty of Medical Sciences in Katowice, Medical University of Silesia in Katowice
Katowice, Silesian Voivodeship, 40-752
About this study
Official title: Impact of Infusion of Balanced Crystalloid and Colloid Solutions on Haemostasis in Healthy Male Volunteers- a Randomized Controlled Crossover Trial
The project focuses on perioperative bleeding that requires transfusion of blood products and supplementation of intravascular volume with crystalloids and colloids. The implemented fluid therapy affects coagulation and fibrinolysis, depending on the type of fluid used in an intravenous infusion. Massive haemorrhage significantly impacts the perioperative period and postoperative quality of life and requires individualized therapy, rending the ongoing project relevant from the perspective of the patients.
Read the 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.
- Conditions
- Perioperative Hemorrhage, Dilutional Coagulopathy
- Being tested
- Standard laboratory coagulation tests and rotational thromboelastometry measurements
- Keywords
- perioperative hemorrhage, fluid therapy, fluid resuscitation, rotational thromboelastometry, goal-directed therapy, dilutional coagulopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard laboratory coagulation tests and rotational thromboelastometry measurementsDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Crystalloid infusion | Experimental | 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 Receives: Diagnostic Test: Standard laboratory coagulation tests and rotational thromboelastometry measurements |
| Colloid infusion | Experimental | 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 Receives: Diagnostic Test: Standard laboratory coagulation tests and rotational thromboelastometry measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotational thromboelastometry (ROTEM) viscoelastic point-of-care coagulation measurements before and after balanced crystalloid infusion
EXTEM, INTEM, FIBTEM assays:
- A10: clot firmness amplitude measured after 10 minutes (mm)
- A20: clot firmness amplitude measured after 20minutes (mm)
- AA: alpha angle (*)
- CFT: clot forming time (s)
- CT: clotting time (s)
- MCE: maximum clot elasticity
- MCF: maximum clot firmness (mm)
- ML: maximum lysis (%)
Measured: 60 minutes
Rotational thromboelastometry (ROTEM) viscoelastic point-of-care coagulation measurements before and after synthetic colloid infusion
EXTEM, INTEM, FIBTEM assays:
- A10: clot firmness amplitude measured after 10 minutes (mm)
- A20: clot firmness amplitude measured after 20minutes (mm)
- AA: alpha angle (*)
- CFT: clot forming time (s)
- CT: clotting time (s)
- MCE: maximum clot elasticity
- MCF: maximum clot firmness (mm)
- ML: maximum lysis (%)
Measured: 60 minutes
Standard laboratory tests reporting coagulation status before and after balanced crystalloid infusion
- fibrinogen concentration (mg/dl)
- APTT: activated partial thromboplastin time (s)
- PT: prothrombin time (s)
- INR: international normalized ratio
- PLT: platelet count (10^3/ul)
- MPV: mean platelet volume (fl)
- PDW: platelet distribution width (fl)
- P-LCR: platelet-large cell ratio (%)
Measured: 60 minutes
Standard laboratory tests reporting coagulation status before and after synthetic colloid infusion
- fibrinogen concentration (mg/dl)
- APTT: activated partial thromboplastin time (s)
- PT: prothrombin time (s)
- INR: international normalized ratio
- PLT: platelet count (10^3/ul)
- MPV: mean platelet volume (fl)
- PDW: platelet distribution width (fl)
- P-LCR: platelet-large cell ratio (%)
Measured: 60 minutes
Standard laboratory tests reporting fibrinolysis status before and after balanced crystalloid infusion
- D-dimer concentration (ug/ml)
Measured: 60 minutes
Standard laboratory tests reporting fibrinolysis status before and after synthetic colloid infusion
- D-dimer concentration (ug/ml)
Measured: 60 minutes
Secondary outcomes (1)
Safety outcomes after crystalloid and colloid infusion
Assessment of safety and potential of adverse events after fluid infusion
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start16 Feb 2021
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perioperative HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Łukasz J Krzych, Professor, Study director, Faculty of Medical Sciences in Katowice, Medical University of SilesiaAgnieszka Wiórek, MD, Principal investigator, Faculty of Medical Sciences in Katowice, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148650
- Sponsor's protocol ID
- KNW/0022/KB1/159/II/15161819
- Status last verified
- Sep 2021
- First submitted
- 29 Sep 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wiorek A, Mazur PK, Niemiec B, Krzych LJ. Association between Functional Parameters of Coagulation and Conventional Coagulation Tests in the Setting of Fluid Resuscitation with Balanced Crystalloid or Gelatine: A Secondary Analysis of an In Vivo Prospective Randomized Crossover Study. J Clin Med. 2022 Jul 14;11(14):4065. doi: 10.3390/jcm11144065.
PubMed 35887829
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Infusion of Balanced Crystalloid and Colloid Solutions on Haemostasis in Healthy Male Volunteers- a Randomized Controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT05148650
- Acronym / sponsor ID
- KNW/0022/KB1/159/II/15161819
- Conditions
- Perioperative Hemorrhage, Dilutional Coagulopathy
- Keywords
- perioperative hemorrhage, fluid therapy, fluid resuscitation, rotational thromboelastometry, goal-directed therapy, dilutional coagulopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project focuses on perioperative bleeding that requires transfusion of blood products and supplementation of intravascular volume with crystalloids and colloids. The implemented fluid therapy affects coagulation and fibrinolysis, depending on the type of fluid used in an intravenous infusion. Massive haemorrhage significantly impacts the perioperative period and postoperative quality of life and requires individualized therapy, rending the ongoing project relevant from the perspective of the patients.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crystalloid infusion | Experimental | Diagnostic Test: Standard laboratory coagulation tests and rotational thromboelastometry measurementsIntravenous (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 |
| Colloid infusion | Experimental | Diagnostic Test: Standard laboratory coagulation tests and rotational thromboelastometry measurementsIntravenous (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 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- Female sex
- Blood type O
- A positive history of any acute diseases in the last four weeks
- Chronic diseases
- Any diagnosed haemostatic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard laboratory coagulation tests and rotational thromboelastometry measurementsBlood 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. | Diagnostic test | Colloid infusion, Crystalloid infusion |
Primary outcome
Rotational thromboelastometry (ROTEM) viscoelastic point-of-care coagulation measurements before and after balanced crystalloid infusion
Time frame: 60 minutes
EXTEM, INTEM, FIBTEM assays: * A10: clot firmness amplitude measured after 10 minutes (mm) * A20: clot firmness amplitude measured after 20minutes (mm) * AA: alpha angle (*) * CFT: clot forming time (s) * CT: clotting time (s) * MCE: maximum clot elasticity * MCF: maximum clot firmness (mm) * ML: maximum lysis (%)
Rotational thromboelastometry (ROTEM) viscoelastic point-of-care coagulation measurements before and after synthetic colloid infusion
Time frame: 60 minutes
EXTEM, INTEM, FIBTEM assays: * A10: clot firmness amplitude measured after 10 minutes (mm) * A20: clot firmness amplitude measured after 20minutes (mm) * AA: alpha angle (*) * CFT: clot forming time (s) * CT: clotting time (s) * MCE: maximum clot elasticity * MCF: maximum clot firmness (mm) * ML: maximum lysis (%)
Standard laboratory tests reporting coagulation status before and after balanced crystalloid infusion
Time frame: 60 minutes
* fibrinogen concentration (mg/dl) * APTT: activated partial thromboplastin time (s) * PT: prothrombin time (s) * INR: international normalized ratio * PLT: platelet count (10^3/ul) * MPV: mean platelet volume (fl) * PDW: platelet distribution width (fl) * P-LCR: platelet-large cell ratio (%)
Standard laboratory tests reporting coagulation status before and after synthetic colloid infusion
Time frame: 60 minutes
* fibrinogen concentration (mg/dl) * APTT: activated partial thromboplastin time (s) * PT: prothrombin time (s) * INR: international normalized ratio * PLT: platelet count (10^3/ul) * MPV: mean platelet volume (fl) * PDW: platelet distribution width (fl) * P-LCR: platelet-large cell ratio (%)
Standard laboratory tests reporting fibrinolysis status before and after balanced crystalloid infusion
Time frame: 60 minutes
- D-dimer concentration (ug/ml)
Standard laboratory tests reporting fibrinolysis status before and after synthetic colloid infusion
Time frame: 60 minutes
- D-dimer concentration (ug/ml)
1 secondary outcome
Safety outcomes after crystalloid and colloid infusion
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Derived from this study: PubMed 35887829Wiorek A, Mazur PK, Niemiec B, Krzych LJ. Association between Functional Parameters of Coagulation and Conventional Coagulation Tests in the Setting of Fluid Resuscitation with Balanced Crystalloid or Gelatine: A Secondary Analysis of an In Vivo Prospective Randomized Crossover Study. J Clin Med. 2022 Jul 14;11(14):4065. doi: 10.3390/jcm11144065.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Łukasz J Krzych, Professor study director
Faculty of Medical Sciences in Katowice, Medical University of Silesia
Agnieszka Wiórek, MD principal investigator
Faculty of Medical Sciences in Katowice, Medical University of Silesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard laboratory coagulation tests and rotational thromboelastometry measurements in people with Perioperative Hemorrhage and Dilutional Coagulopathy, run by Medical University of Silesia at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rotational thromboelastometry (ROTEM) viscoelastic point-of-care coagulation measurements before and after balanced crystalloid infusion (time frame: 60 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05148650, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.