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

NCT01854476 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2015-02-13

No results posted yet for this study

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

Conditions

Interventions

DEVICE

pad-gauze with tranexamic acid (Hemostopan™)

The use of pad-gauze containing tranexamic acid (Hemostopan™)

Sponsors & Collaborators

  • Sion Microtec Ltd.

    lead INDUSTRY

Principal Investigators

  • Mudi Misgav, MD · Sheba Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-06-30
Completion
2015-08-31

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01854476 on ClinicalTrials.gov