Effect of the plasma substitutes Gelofusine and Hydroxyethyl Starch 130/0.4 combined with lactated ringer's solution on the coagulation system

A standard component of the priming which is used within the department of
extra corporal circulation (ECC) of the Amphia hospital Breda, is the synthetic
colloïd Gelofusine (Braun, Melsung AG, Germany). Because of logistical reasons
and cost saving the question is arised if Gelofusine can be replaced by the
synthetic colloïd Hydroxyethyl Starch (HES) 130.04 (Fresenius Kabi). In these
randomized clinical trial study will be examined if Gelofusine can be replaced
by HES 130/0.4, examinating post operative thorax drains production on the
intensive care.

The study from the Fries et al, already has proven that there be no difference
in coagulation between Ringerlactate/ Gelofusine priming and
RIngerlactate/ HES 130.04 priming. Because this was an in vitro model, the
endotheel impact, farmokinetic and metabolism of these synthetic colloïds is
not being examined. These results are different to extrapolate to in vivo. With
these prospectieve study there will be examined in vivo the difference between
Ringerlactate/Gelofusine priming and Ringerlactate/HES 130/0.4 priming on
coagulation

The main objective in this study is to examine if there is a difference in
coagulation between Ringerlactaat/Gelofusine® priming and Ringerlactaat/HES
130/0.4 priming after coronary artery bypass graft (CABG), by measuring the
thorax drain production on the intensive care.
Also the effect at coagulation after a CABG procedure wille be examined by
using the tromboelastography (rotation tromboealastometry, ROTEM; Pentapharm,
München, Germany) and laboratory parameters.

The study has been split up in three parts:
- Pilot study: to learn te skills and evaluate the model
- To examine of there is a difference in coagulation between
Ringerlactate/Gelofusine priming and Ringerlactate/HES 130.04 priming after a
CABG procede, by measuring the thorax drain production on the intensive care.
- To examine there is a difference in coagulation by using the tromboelastogram
and laboratory parameters between Ringerlactate/Gelofusine priming and
Ringerlactate/ HES 1300.4 after a CABG procedure.

There is a minimum tax for the patient.

The data which are collected during the study of one patient are:
- results of the coagulation pre operative (two evacuated blood collection
tubes of 5 cc)
- results of the coagulation post operative (three evacuated blood collection
tubes of 5 cc)
- blood loss on the intensive care

Three of the five evacuated blood collection tubes that are taken, are the
standard procedure. Thus will be also taken when the patient would not
participate at the study. Also the measuring of the blood loss after the
operation is a standard procedure.

There is a minimum risk by replacing Gelofusine by HES 130/0.4 during the
operation procedure. procedure. HES 130/0.4 is already used as standard
substitutie fluid on the intensive care. Furthermore HES 130/0.4 is already
used during open heart surgery where a heart lung machine is involved in other
hospitals as a substitutie fluids . Before the procedure it is calculated what
the maximum quantity is of HES 130/0.4. By overriding NaCl or Ringerlactate
are given (See protocol). Because the risk of this study is minimum, a
dispensation for the insurance has been asked.