Perioperative Hemorrhage Clinical Trial
Official title:
Impact of Infusion of Balanced Crystalloid and Colloid Solutions on Haemostasis in Healthy Male Volunteers- a Randomized Controlled Crossover Trial
Verified date | September 2021 |
Source | Medical University of Silesia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 25 |
Est. completion date | December 2021 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 30 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Poland | Department of Anaesthesiology and Intensive Care, Faculty of Medical Sciences in Katowice, Medical University of Silesia in Katowice | Katowice | Silesia |
Lead Sponsor | Collaborator |
---|---|
Medical University of Silesia |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 (%) |
60 minutes | |
Primary | 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 (%) |
60 minutes | |
Primary | 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 (%) |
60 minutes | |
Primary | 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 (%) |
60 minutes | |
Primary | Standard laboratory tests reporting fibrinolysis status before and after balanced crystalloid infusion | - D-dimer concentration (ug/ml) | 60 minutes | |
Primary | Standard laboratory tests reporting fibrinolysis status before and after synthetic colloid infusion | - D-dimer concentration (ug/ml) | 60 minutes | |
Secondary | Safety outcomes after crystalloid and colloid infusion | Assessment of safety and potential of adverse events after fluid infusion | 28 days |