Intra-Operative Injury - OtherPhase 3PHORBBSNCT03085394
Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery
A Phase 3 study testing tranexamic acid in people with Intra-Operative Injury - Other and Post Operative Hemorrhage, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Prophylactic use of tranexamic acid to reduce intra and postoperative bleeding in primary sleeve gastrectomy procedures will be studied. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intra-Operative Injury - Other, Post Operative Hemorrhage, Tranexamic Acid
- What is being tested?
- tranexamic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Sep 2017to 21 Nov 2022
- Phase
- Phase 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Morbid obesity
- Approved and scheduled for laparoscopic sleeve gastrectomy
Who cannot join
- Previous bariatric surgery
- Platelet count under 100,000
- Concurrent anticoagulation treatment
- Previous venous/atrerial thromboembolic event
- Known allergy to tranexamic acid
- History of heparin induced thrombocytopenia
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- Oral contraceptive use
- Female hormonal replacement therapy
- Active thromboembolic state
- Genetic hypercoagulable state
Trial locations and contacts
1 site in 1 country.
About this study
Prophylactic use of tranexamic acid to reduce intra and postoperative bleeding in primary sleeve gastrectomy procedures will be studied.
Read the detailed description
Patients scheduled for primary laparoscopic sleeve gastrectomy for the treatment of morbid obesity will be assigned to receive tranexamic acid vs. placebo before surgery. Intraoperative bleeding will be scored, as well as postoperative bleeding and blood or blood-product requirements. POstoperative venous thromboembolic events will be recorded up to 2 months following surgery.
- Being tested
- tranexamic acid, Placebo
- Keywords
- Morbid Obesity, Sleeve gastrectomy
- Medical subject headings
- Postoperative Hemorrhage, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tranexamic acidDrug
Also called Hexakapron
Preoperative intravenous administration of 2 grams tranexamic acid in 10 ml saline
PlaceboDrug
Preoperative intravenous administration of 10 ml saline
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Active comparator | Preoperative intravenous administration of 2g tranexamic acid in 10ml fluid. Receives: Drug: tranexamic acid |
| Control Arm | Placebo comparator | Preoperative intravenous administration of 10ml normal saline. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment efficiency (lowering/preventing clinically significant bleeding)
The efficiency of preoperative tranexamic acid administration in lowering/preventing clinically significant bleeding.
Measured: 1 week
Treatment safety (administering tranexamic acid preoperatively without promoting thromboembolic events)
The safety of administering tranexamic acid preoperatively without promoting thromboembolic events
Measured: 2 months
Secondary outcomes (3)
Need for reintervention
The proportion of patients requiring invasive intervention (percutaneous/operative) due to bleeding
Measured: 1 week
Procedure change
The proportion of patients requiring alteration of intended procedure due to bleeding.
Measured: 1 day
Blood/blood product requirement
The usage of blood/blood products after surgery
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start1 Sep 2017
- Primary completion21 Nov 2022
- Study completion21 Nov 2022
Why it stopped: Enrollment stopped, patients refuse to participate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-Operative Injury - OtherStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, David Goitein MD, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085394
- Sponsor's protocol ID
- SMC-17-3846
- Acronym
- PHORBBS
- Status last verified
- Apr 2023
- First submitted
- 19 Mar 2017
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03085394
- Acronym / sponsor ID
- PHORBBS / SMC-17-3846
- Keywords
- Morbid Obesity, Sleeve gastrectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment stopped, patients refuse to participate.
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 21 Nov 2022 (actual)
- Study completion
- 21 Nov 2022 (actual)
- First posted
- 21 Mar 2017 (actual)
- 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.
Prophylactic use of tranexamic acid to reduce intra and postoperative bleeding in primary sleeve gastrectomy procedures will be studied.
Detailed description
Patients scheduled for primary laparoscopic sleeve gastrectomy for the treatment of morbid obesity will be assigned to receive tranexamic acid vs. placebo before surgery. Intraoperative bleeding will be scored, as well as postoperative bleeding and blood or blood-product requirements. POstoperative venous thromboembolic events will be recorded up to 2 months following surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Active comparator | Drug: tranexamic acidPreoperative intravenous administration of 2g tranexamic acid in 10ml fluid. |
| Control Arm | Placebo comparator | Drug: PlaceboPreoperative intravenous administration of 10ml normal saline. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Morbid obesity
- Approved and scheduled for laparoscopic sleeve gastrectomy
Key exclusion criteria (10 listed)
- Previous bariatric surgery
- Platelet count under 100,000
- Concurrent anticoagulation treatment
- Previous venous/atrerial thromboembolic event
- Known allergy to tranexamic acid
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 |
|---|---|---|
| tranexamic acidAlso: HexakapronPreoperative intravenous administration of 2 grams tranexamic acid in 10 ml saline | Drug | Treatment arm |
| PlaceboPreoperative intravenous administration of 10 ml saline | Drug | Control Arm |
Primary outcome
Treatment efficiency (lowering/preventing clinically significant bleeding)
Time frame: 1 week
The efficiency of preoperative tranexamic acid administration in lowering/preventing clinically significant bleeding.
Treatment safety (administering tranexamic acid preoperatively without promoting thromboembolic events)
Time frame: 2 months
The safety of administering tranexamic acid preoperatively without promoting thromboembolic events
3 secondary outcomes
Need for reintervention
Time frame: 1 week
Procedure change
Time frame: 1 day
Blood/blood product requirement
Time frame: 1 week
Results and safety
The study was stopped early (reason given: Enrollment stopped, patients refuse to participate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
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 record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tranexamic acid in people with Intra-Operative Injury - Other and Post Operative Hemorrhage, run by Sheba Medical Center 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 10 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: stopped early, as of the sponsor's last update on 19 Apr 2023. 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 phase mean?
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?
The study was stopped early (reason given: Enrollment stopped, patients refuse to participate.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment efficiency (lowering/preventing clinically significant bleeding) (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2023.