Safety and Efficacy Study Comparing Pad-gauze With Anti-fibrinolytic Agent Hemostopan™) to a Regular Pad-gauze

February 12, 2015 updated by: Sion Microtec Ltd.

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

Study Overview

Status

Unknown

Conditions

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ramat-Gan, Israel, 52621
        • Recruiting
        • The dialysis unite at the Sheba Medical center
        • Contact:
        • Sub-Investigator:
          • Sharon Mini, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tranexamic acid
pad-gauze with tranexamic acid (Hemostopan™)
The use of pad-gauze containing tranexamic acid (Hemostopan™)
Placebo Comparator: Pad gauze
Pad gauze with no tranexamic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to hemostasis
Time Frame: 10 minutes
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mudi Misgav, MD, Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

August 1, 2015

Study Registration Dates

First Submitted

May 12, 2013

First Submitted That Met QC Criteria

May 14, 2013

First Posted (Estimate)

May 15, 2013

Study Record Updates

Last Update Posted (Estimate)

February 13, 2015

Last Update Submitted That Met QC Criteria

February 12, 2015

Last Verified

February 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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