Ex vivo study: What is the relation between increasing heparin concentrations and different protamine:heparin-ratio*s with POC-PT values in blood drawn from healthy volunteers?Clinical study in cardiac surgery: Does the POC-PT device correspond with…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The International Normalized Ratio (INR) of the prothrombin time (PT) as
measured with Coaguchek Plus or routine laboratory tests.
Secondary outcome
The ex vivo effect of different protamine:heparin ratio on the POC-PT.
Background summary
After cardiac surgery information about the coagulation status is required to
know if the patient is suspected for coagulopathy. The value of routine
laboratory coagulation tests in this setting is restricted by their extensive
turnaround times, which estimate 30-60 minutes. The point-of-care (POC)
coagulation monitoring device, Coaguchek Pro, which measures the prothrombin
time (PT) within 3 minutes, may overcome this limitation. Only a few studies
have evaluated the device in patients undergoing cardiac surgery.
During cardiac surgery patients receive heparin prior to cardiopulmonary bypass
(CPB) to prevent the blood to clot in the extracorporeal circulation. In
addition, after weaning from CPB, heparin is reversed by protamine, which in
itself acts as an anticoagulant if administered in excess. Due to these
factors, which significantly influence hemostasis, coagulation monitors have to
be separately validated for their use after CPB. Therefore we aim to evaluate
the effect of different heparin concentrations and protamine-heparin ratio*s on
the POC-PT in an in vitro setting in blood from healthy volunteers. The second
aim of our study is to investigate the optimal timing for POC-PT testing after
protamine administration.
Study objective
Ex vivo study:
What is the relation between increasing heparin concentrations and different
protamine:heparin-ratio*s with POC-PT values in blood drawn from healthy
volunteers?
Clinical study in cardiac surgery:
Does the POC-PT device correspond with the classical laboratory prothrombin
time before cardiopulmonary bypass and 3, 6 and 10 minutes following protamine
administration in patients undergoing elective cardiac surgery with
cardiopulmonary bypass?
Study design
Prospective, single center, observational study in the VUmc
Study burden and risks
There are no serious adverse events expected since all procedures are standard
clinical care and do not comprise an intervention that may harm the volunteer
or patient. In total 20 mL blood will be drawn from volunteer or patient.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Ex-vivo study
- Healthy volunteers
- Age 18 * 90 years
- Informed consent;Clinical study in cardiac surgery
- Patients undergoing elective cardiothoracic surgery
- Age 18-90 years
- Preoperative hemoglobin of > 5.5 mmol/l
- Informed consent
Exclusion criteria
Ex vivo study
- Subjects with hemostatic deficiencies or previous hemostatic problems
- Subjects using vitamin K antagonists, clopidogrel or dabigatran at the time of surgery.
- Pregnancy;Clinical study in cardiac surgery
- Re-operations and emergency operations
- Use of erythropoietin
- Hepatic or renal failure
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL43303.029.13 |