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.
Verified date | February 2015 |
Source | Sion Microtec Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Unknown status |
Enrollment | 25 |
Est. completion date | August 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients that require at least 10 minutes for hemostasis - Patient over 18 years of age that are capable of signing an informed consent Exclusion Criteria: - Patients with HIV, HCV or HBV chronic infection - Known hypersensitivity to polydine |
Country | Name | City | State |
---|---|---|---|
Israel | The dialysis unite at the Sheba Medical center | Ramat-Gan |
Lead Sponsor | Collaborator |
---|---|
Sion Microtec Ltd. |
Israel,
1.Remuzzi G, Livio M, Marchiaro G, Mecca G, de Gaetano G.Bleeding in renal failure: altered platelet function in chronic uraemia only partially corrected by haemodialysis. Nephron. 1978;22(4-6):347-53. 2.Akizawa T, Kinugasa E, Kitaoka T, Koshikawa S. Effects of recombinant human erythropoietin and correction of anemia on platelet function in hemodialysis patients. Nephron 1991;58:400-6. 3.Mezzano D, Panes O, Muñoz B, Pais E, Tagle R, González F, Mezzano S, Barriga F, Pereira J.Tranexamic acid inhibits fibrinolysis, shortens the bleeding time and improves platelet function in patients with chronic renal failure. ThrombHaemost. 1999 Oct;82(4):1250-4. 4.Saran R, Pisoni RL, Weitzel WF. Epidemiology of vascular access for hemodialysis and related practice patterns. ContribNephrol 2004; 142: 14-28. 5.Wu CC, Ho WM, Cheng SB, Yeh DC, Wen MC, Liu TJ, P'eng FK. Perioperative parenteral tranexamic acid in liver tumor resection: a prospective randomized trial toward a
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to hemostasis | 10 minutes |
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