No registrations found.
ID
Source
Health condition
Haemolysis, extracorporeal CO2 removal, low flow CO2 removal, extracorporeal life support, ELS, COPD, exacerbation, chronic obstructive pulmonary disease, acute lung failure.
Hemolyse, extracorporale CO2 verwijdering, extracorporale ondersteuning, exacerbatie, acuut longfalen.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Normalised index of haemolysis (NIH).*
*Plasma free haemoglobin is measured in duplo at the beginning and end of an in vitro run in order to calculate the NIH.
Secondary outcome
Pump speed (in rpm).
In vitro circuit pressures (in mmHg).
In vitro circuit temperature (in oC).
Background summary
Extracorporeal life support (ELS) has proven a successful technique to provide cardiopulmonary assistance in acute heart and/or lung failure. Adapted towards a low-flow application using low pump flows and small catheters, ELS can be used for extracorporeal CO2 removal in patients suffering from exacerbation of chronic obstructive pulmonary disease.
In this prospective study an in vitro setup will be filled with donated fresh human blood from healthy volunteers willing to donate approximately 200 ml. Different catheter sizes and flow rates are used (in triplo) in order to investigate a relationship between haemolysis (plasma free haemoglobin) and extracorporeal life support-related parameters such as pump flow, catheter selection, pump speed, pump pressures and pump heating.
Study objective
Objective: to investigate in vitro a relationship between plasma free haemoglobin and extracorporeal life support-related parameters such as pump flow, catheter selection, pump speed and pump heating.
1. Blood flow is positively related to plasma free hemoglobin, circuit pressures and circuit temperature.
2. Decreasing catheter diameter aggravates the relationship between blood flow, plasma free hemoglobin, circuit pressures and circuit temperature.
Study design
After choosing a catheter size and flow rate, there are two main timepoints for recording data:
- 5 minutes after the start of the blood pump: pump speed (pump display), flow rate (pump display), pump inlet / outlet pressures (pump display), circuit temperature before and after pump (temperature probes), free haemoglobin (blood sample in duplo, laboratory maesurement).
- 6 hours after the start of the blood pump: pump speed (pump display), flow rate (pump display), pump inlet / outlet pressures (pump display), circuit temperature before and after pump (temperature probes), free haemoglobin (blood sample in duplo, laboratory maesurement).
Interim recordings (every hour) include blood flow rate, pump speed, temperature and circuit pressures.
Intervention
30 healthy volunteers will donate approximately 200 ml whole blood, drawn by aseptic vena punction by an experienced physician and collected in a blood donation bag containing citrate for anticoagulation. Blood is donated under standard transfusion laboratory conditions, i.e. lying on a bed, with vital parameter monitoring, and fluid supply by drinking water during and after donation.
Dept. of Cardiothoracic Surgery<br>
P.O. Box 5800
A.P. Simons
P. Debyelaan 25
Maastricht 6202 AZ
The Netherlands
+31-43-38 75070 (secretary)
antoinepsimons@ctc.unimaas.nl
Dept. of Cardiothoracic Surgery<br>
P.O. Box 5800
A.P. Simons
P. Debyelaan 25
Maastricht 6202 AZ
The Netherlands
+31-43-38 75070 (secretary)
antoinepsimons@ctc.unimaas.nl
Inclusion criteria
Healthy volunteer.
Age and gender not relevant.
Exclusion criteria
Volunteers known with anaemia or those not feeling well.
Volunteer that has taken part in this study and has donated blood during the past 7 days.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4746 |
| NTR-old | NTR4874 |
| Other | METC : 142042 |