BleedingPhase 2/3NCT01854476
Safety and Efficacy Study Comparing Pad-gauze With Anti-fibrinolytic Agent Hemostopan™) to a Regular Pad-gauze
A Phase 2/3 study testing pad-gauze with tranexamic acid (Hemostopan™) in people with Bleeding and Coagulopathy, run by Sion Microtec Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding, Coagulopathy
- What is being tested?
- pad-gauze with tranexamic acid (Hemostopan™)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2013to Aug 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients that require at least 10 minutes for hemostasis
- Patient over 18 years of age that are capable of signing an informed consent
Who cannot join
- Patients with HIV, HCV or HBV chronic infection
- Known hypersensitivity to polydine
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
The dialysis unite at the Sheba Medical center
Ramat Gan, Israel, 52621
Mudi Misgav, MD, 972-3-5302950 ext. 6, mudi.misgav@gmail.com
Sharon Mini, MD
About this study
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.
Read more
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
Read the 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
- Conditions
- Bleeding, Coagulopathy
- Being tested
- pad-gauze with tranexamic acid (Hemostopan™)
- Keywords
- Hemodialysis, Bleeding, Hemostatic dressing, Tranexamic Acid
- Medical subject headings
- Hemorrhage, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pad-gauze with tranexamic acid (Hemostopan™)Device
The use of pad-gauze containing tranexamic acid (Hemostopan™)
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Experimental | pad-gauze with tranexamic acid (Hemostopan™) Receives: Device: pad-gauze with tranexamic acid (Hemostopan™) |
| Pad gauze | Placebo comparator | Pad gauze with no tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to hemostasis
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sion Microtec Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mudi Misgav, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854476
- Sponsor's protocol ID
- SionM1
- Status last verified
- Feb 2015
- First submitted
- 12 May 2013
- Last updated
- 13 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
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 at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01854476
- Acronym / sponsor ID
- SionM1
- Conditions
- Bleeding, Coagulopathy
- Keywords
- Hemodialysis, Bleeding, Hemostatic dressing, Tranexamic Acid
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Sion Microtec Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 15 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Device: pad-gauze with tranexamic acid (Hemostopan™)pad-gauze with tranexamic acid (Hemostopan™) |
| Pad gauze | Placebo comparator | –Pad gauze with no tranexamic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients that require at least 10 minutes for hemostasis
- Patient over 18 years of age that are capable of signing an informed consent
Key exclusion criteria (2 listed)
- Patients with HIV, HCV or HBV chronic infection
- Known hypersensitivity to polydine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pad-gauze with tranexamic acid (Hemostopan™)The use of pad-gauze containing tranexamic acid (Hemostopan™) | Device | Tranexamic acid |
Primary outcome
Time to hemostasis
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2015.
- Background1.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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The dialysis unite at the Sheba Medical center
Ramat Gan, Israel
Mudi Misgav, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing pad-gauze with tranexamic acid (Hemostopan™) in people with Bleeding and Coagulopathy, run by Sion Microtec Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to hemostasis (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01854476, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2015.