Perioperative/Postoperative Complications Clinical Trial
Official title:
Haemostasis Management of Patients Undergoing Abdominal Aortic Procedures Associated With High Bleeding Risk
Verified date | February 2018 |
Source | University of Pecs |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Comparative study on efficacy of haemostatic therapy guided either by standard laboratory
coagulation parameters or point-of-care testing in patients undergoing vascular surgical
procedures. We investigate the amount of perioperative bleeding and the number of blood
product used.
Inclusion criteria Patients scheduled for elective and acute open aorta surgery or undergoing
acute aorta surgery with minimally invasive techniques and were provided treatment in the
operating theatre and/or ICU attached to perioperative care, they must be at least 18 years
of age and written informed consent was obtained from the patient or his/her legal
representative.
Randomisation technique Patients will be randomly assigned to each of two treatment groups
using sealed envelopes. In group 1 (G1) haemostasis strategy guided by conventional
coagulation tests, while in group 2 (G2) transfusion algorithms guided by point-of-care (POC)
tests will be carried out.
Sampling techniques and measurements
For assessment of monitored parameters shall be used arterial or venous blood depending on
the catheter placed preoperatively. In case of the above mentioned vascular surgical
procedures, all patients will receive arterial cannula routinely, and, depending on the
extension of procedure, as appropriate, a central venous catheter will be inserted as well.
Sampling in the patient groups shall be performed as follows:
- pre- and postoperative evaluation of standard laboratory parameters in all patients
- evaluation of standard laboratory parameters and arterial Astrup test during and after
surgery in group 1, if the blood loss volume reaches 1,5 ml/kg/minute during 20 minutes
- in case of elective surgery: thromboelastometry and arterial Astrup test during and
after surgery in group 2 if the blood loss volume reaches 1,5 ml/kg/minute during 20
minutes
- in case of acute surgery: thromboelastometry and arterial Astrup test before, during and
after surgery in group 2
- in case of positive anamnesis, preoperative platelet aggregation test in both groups
Besides the above samplings, routine lab tests (blood gas, blood count, sodium (Na),
potassium (K), parameters of renal and liver function, clotting and inflammation, lactic
acid, blood sugar) will be performed every day as usual during intensive therapy.
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - patients scheduled for elective and acute open aorta surgery or undergoing acute aorta surgery with minimally invasive techniques and were provided treatment in the operating theatre and/or ICU attached to perioperative care - they must be at least 18 years of age - written informed consent was obtained from the patient or his/her legal representative. Exclusion Criteria: - patients under 18 years of age - informed consent not provided - congenital coagulation factor deficiency - congenital thrombocytopathy |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Pecs |
Kozek-Langenecker SA, Ahmed AB, Afshari A, Albaladejo P, Aldecoa C, Barauskas G, De Robertis E, Faraoni D, Filipescu DC, Fries D, Haas T, Jacob M, Lancé MD, Pitarch JVL, Mallett S, Meier J, Molnar ZL, Rahe-Meyer N, Samama CM, Stensballe J, Van der Linden PJF, Wikkelsø AJ, Wouters P, Wyffels P, Zacharowski K. Management of severe perioperative bleeding: guidelines from the European Society of Anaesthesiology: First update 2016. Eur J Anaesthesiol. 2017 Jun;34(6):332-395. doi: 10.1097/EJA.0000000000000630. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The number of blood products used | 24 hours | ||
Primary | Amount of perioperative bleeding | 24 hours |
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