|- candidate number||20844|
|- NTR Number||NTR4874|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-okt-2014|
|- Secondary IDs||142042 METC|
|- Public Title||Haemolysis during extracorporeal CO2 removal; a laboratory study using donated human blood.|
|- Scientific Title||Haemolysis during extracorporeal CO2 removal; an in vitro study using donated human blood.|
|- hypothesis||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.
|- Healt Condition(s) or Problem(s) studied||Haemolysis, Extracorporeal CO2 removal, Acute lung failure, Exacerbation, COPD|
|- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-okt-2014|
|- planned closingdate||30-apr-2015|
|- Target number of participants||30|
|- Interventions||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.|
|- 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).
|- Timepoints||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.
|- Trial web site|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Dr. A.P. Simons|
|- CONTACT for SCIENTIFIC QUERIES||Dr. A.P. Simons|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|Maastricht University Medical Center (MUMC+)|
|- Brief 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.
|- Main changes (audit trail)||12-mrt-2015: Status trial: Onderzoek afgerond-EB|
|- RECORD||30-okt-2014 - 12-mrt-2015|