Safety and Efficacy Study Comparing Pad-gauze With Anti-fibrinolytic Agent Hemostopan™) to a Regular Pad-gauze
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.
1 other identifier
interventional
25
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2013
CompletedFirst Posted
Study publicly available on registry
May 15, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedFebruary 13, 2015
February 1, 2015
1.7 years
May 12, 2013
February 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to hemostasis
10 minutes
Study Arms (2)
Tranexamic acid
EXPERIMENTALpad-gauze with tranexamic acid (Hemostopan™)
Pad gauze
PLACEBO COMPARATORPad gauze with no tranexamic acid
Interventions
The use of pad-gauze containing tranexamic acid (Hemostopan™)
Eligibility Criteria
You may qualify if:
- Patients that require at least 10 minutes for hemostasis
- Patient over 18 years of age that are capable of signing an informed consent
You may not qualify if:
- Patients with HIV, HCV or HBV chronic infection
- Known hypersensitivity to polydine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The dialysis unite at the Sheba Medical center
Ramat Gan, Israel, 52621, Israel
Related Publications (1)
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
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mudi Misgav, MD
Sheba Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2013
First Posted
May 15, 2013
Study Start
October 1, 2013
Primary Completion
June 1, 2015
Study Completion
August 1, 2015
Last Updated
February 13, 2015
Record last verified: 2015-02