Bleeding Clinical Trial
Official title:
A Double-bline Safety and Efficacy Study Comparing Pad-gauze With Tranexamic Acid (Hemostopan™) to a Regular Pad-gauze in Controlling Bleeding in Patients on Hemodialysis.
Patients on chronic treatment with hemodialysis have an arterio-venous fistula which enable
the insertion of two large gauge needles. At the end of dialysis the needles are extracted
and continuous pressure is needed to stop the bleeding. Time to bleeding cessation is
different between patients and may be up to 20 minutes. Acquired coagulopathy in patients on
chronic hemodylasis is a well known entity. The coagulopathy is multi-factorial including
uremic thrombocytopathia, the presence of anemia, the use of anti-platelets and/or
anti-coagulation drugs and the regular use of heparin during dialysis. Tranexamic acid
(Hexakapron) is an anti-fibrinolytic drug that has a proven efficacy in reducing blood loss
at different clinical settings. The drug may be given systemically (PO/IV) or applied locally
on the site of injury.
The aim of the study is to assess the efficacy and safety of a pad gauze dressing containing
tranexamic acid.
Study design:
A Double-blind study comparing pad-gauze with tranexamic acid (Hemostopan™) to a regular
pad-gauze. The type of dressing for each dialysis session will be decided in a random manner.
In each dialysis session only one type of dressing will be used for both insertion points.
Protocol for applying the dressing:
Following the needle extraction either dressing "A" or "B" will applied with slight pressure
for 2 minutes. If bleeding stops it will be the end of session.
If bleeding persists than another dressing of the same kind is applied with slight pressure
for 4 minutes. If bleeding stops it will be the end of session.
If bleeding persists than another dressing of the same kind is applied with slight pressure
for 6 minutes. If bleeding stops it will be the end of session.
If bleeding persists than it will be consider a failure and a regular measures will be used
until bleeding stops.
Each session will be documented in the patient's case report file (CRF). The primary end
point of the study: Time to bleeding cessation
A Double-blind safety and efficacy study comparing pad-gauze with tranexamic acid
(Hemostopan™) to a regular pad-gauze in controlling bleeding in patients on hemodialysis.
Background:
Patients with end-stage renal disease are on chronic treatment with hemodialysis. Most
patients have and arterio-venous fistula which enable the insertion of two large gauge
needles. At the end of dialysis the needles are extracted and continuous pressure is needed
to stop the bleeding. Time to hemostasis is different between patients and may be up to 20
minutes for each insertion point. Acquired coagulopathy in patients on chronic hemodylasis is
a well known entity which have an important impact on time to hemostasis. The coagulopathy is
multi-factorial composed including uremic thrombocytopathia, the presence of anemia, the use
of anti-platelets and / or anti-coagulation drugs and the regular use of heparin during the
dialysis process. Tranexamic acid (Hexakapron) is an anti-fibrinolytic drug that has a proven
efficacy in reducing blood loss at different clinical settings. The drug may be given
systemically (PO / IV) or applied locally on the site of injury.
The aim of the study To study the efficacy and safety of a pad gauze dressing containing
tranexamic acid.
Inclusion criteria:
Patients that requires at least 10 minutes for hemostasis will be considered candidates for
the study. Among those, only patient over 18 years of age that will sign an informed consent
will be recruited.
Exclusion criteria:
Patients with HIV, HCV or HBV chronic infection. Known hypersensitivity to polydine.
Study design:
A Double-blind study comparing pad-gauze with tranexamic acid (Hemostopan™) to a regular
pad-gauze. The type of dressing for each dialysis session will be decided in a random manner.
In each dialysis session only one type of dressing will be used for both insertion points.
The dressing are identical in their appearance and are marked as dressing "A" or dressing
"B". All of the participants including - patients, physician, nurses and study coordinator
will be blinded to the treatments. In ta course of the study each dressing will be applied 10
times in a given patient so in practical each patient will be his own control.
Protocol for applying the dressing:
Following the needle extraction either dressing "A" or "B" will applied with slight pressure
for 2 minutes. If bleeding stops it will be the end of session.
If bleeding persists than another dressing of the same kind is applied with slight pressure
for 4 minutes. If bleeding stops it will be the end of session.
If bleeding persists than another dressing of the same kind is applied with slight pressure
for 6 minutes. If bleeding stops it will be the end of session.
If bleeding persists than it will be consider a failure and a regular measures will be used
until bleeding stops.
Each session will be documented in the patient's case report file (CRF).
The primary end point of the study:
Time to hemostasis
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