Prevention of local thromboembolic complications during continuous infusion of coagulation factor concentrates: parallel infusion of saline versus heparin and parallel infusion of saline?

At the time of introduction of continuous infusion of clotting factor
concentrates, thrombophlebitis was a frequently seen complication. In the 90's
a small amount of heparin was experimentally added to the clotting factor
concentrates during continous infusion in order to prevent thrombophlebitis and
some centres have been using this method ever since. Recent developments in the
field of clotting factor concentrates have led to the improvement of these
products. Moreover, worldwide there are different methods in use to prevent
thrombophlebitis, such as parallel infusion of saline. No comparative studies
on this topic have been performed to define the best prophylactic regimen and
the current prophylactic treatment of thrombophlebitis is therefore not
evidence based. Because adding heparin is not free of risks, parallel infusion
of saline has the potential of being safer. In this trial we want to evaluate
the efficacy of a parallel infusion of saline compared to heparin in the
prevention of local thromboembolic complications in patients treated with
continuous infusion of clotting factor concentrates.

To demonstrate that parallel infusion of saline added to the continous infusion
of clotting factor concentrates prevents local thromboembolic complications to
the same extent as heparin together with a parallel infusion of saline does.

An open label randomised trial.

Two interventions will be compared. In the first group the intervention
consists of adding heparin, next to a parallel infusion of saline, to the
clotting factor concentrates during continous infusion. In the second group the
intervention consists of parallel infusion of saline to the continuous infusion
of clotting factor concentrates.

It is not expected that the group of patients who will receive a parallel
infusion of saline have a higher risk for developing thrombophlebitis than the
group of patients who will receive heparin. There is very low risk with regard
to serious complications.
However, there is a possibility that if the patient needs extra intravenous
saline according to the treating physician, a second entry must be placed for
intravenous infusion.

This trial will contribute to an evidence-based protocol for prophylactic
treatment for local thromboembolic complications seen in continuous infusion of
clotting factor concentrates. Possibly this can lead to safer treatment regime.