Blood, Injection, Injury Type PhobiaNCT01560702
Comparative Study of Autologous Blood Injection Versus Diluted Epinephrine in Treating Actively Bleeding Gastroduodenal Ulcers
A study testing Epinephrine and Blood in people with Blood, Injection, Injury Type Phobia and Gastrointestinal Ulcer Haemorrhage, run by Zagazig University at 1 site in Egypt.
Trial summary
Endoscopic injection of autologous blood can control bleeding from gastroduodenal ulcers. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Blood, Injection, Injury Type Phobia, Gastrointestinal Ulcer Haemorrhage, Adverse Reaction to Epinephrine
- What is being tested?
- Epinephrine and Blood
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2012to Sep 2013
- Phase
- Interventional
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- all adult patients with gastroduodenal ulcer
Who cannot join
- Patients with non ulcer bleeding.
- Patients with malignancy.
- Patients with bleeding disorders or under coagulation therapy.
- Patients with known allergy to epinephrine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Injection of Autologous Blood Versus Diluted Epinephrine for Control of Actively Bleeding Gastroduodenal Ulcers
Endoscopic injection of autologous blood can control bleeding from gastroduodenal ulcers.
Read the detailed description
To test the hypothesis that endoscopic injection of autologous blood is superior to endoscopic injection of diluted epinephrine in controlling bleeding from gastroduodenal ulcers.
- Conditions
- Blood, Injection, Injury Type Phobia, Gastrointestinal Ulcer Haemorrhage, Adverse Reaction to Epinephrine
- Being tested
- Epinephrine, Blood
- Keywords
- autologous blood, epinephrine, endoscopy, ulcer, hemostasis
- Medical subject headings
- Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpinephrineDrug
10-30 cc of 1/10000 diluted epinephrine will be injected at edges of an actively bleeding ulcer.
BloodBiological
5-20 cc autologous blood immediately withdrawn from the patient will be injected at edges of the actively bleeding ulcer.
| Study group | Role | What they receive |
|---|---|---|
| Autologous blood | Active comparator | Patients will be injected by autologous blood at the edge of actively bleeding ulcer Receives: Biological: Blood |
| Epinephrine injection | Other | Patients will be injected by diluted epinephrine at the edge of actively bleeding ulcer Receives: Drug: Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemostasis from the ulcer after injection and/or stoppage of haematemesis and melena one day after the procedure.
Measured: 12 months
Secondary outcomes (1)
development of re-bleeding after 24 hours after the procedure (occurrence of hematemesis or melena or drop of hemoglobin level >2gm/dl).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood, Injection, Injury Type PhobiaStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Moahmed Hassan Emara, Zagazig University
- Investigators
- Mohamed H Emara, MD, Principal investigator, Tropical Medicine Department, Faculty of Medicine, Zagazig University, Zagazig, 44519, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560702
- Sponsor's protocol ID
- IRB#:278/12-3-2012
- Status last verified
- Sep 2013
- First submitted
- 20 Mar 2012
- Last updated
- 25 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Injection of Autologous Blood Versus Diluted Epinephrine for Control of Actively Bleeding Gastroduodenal Ulcers
- ClinicalTrials.gov ID
- NCT01560702
- Acronym / sponsor ID
- IRB#:278/12-3-2012
- Conditions
- Blood, Injection, Injury Type Phobia, Gastrointestinal Ulcer Haemorrhage, Adverse Reaction to Epinephrine
- Keywords
- autologous blood, epinephrine, endoscopy, ulcer, hemostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- Mar 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 22 Mar 2012 (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.
Endoscopic injection of autologous blood can control bleeding from gastroduodenal ulcers.
Detailed description
To test the hypothesis that endoscopic injection of autologous blood is superior to endoscopic injection of diluted epinephrine in controlling bleeding from gastroduodenal ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous blood | Active comparator | Biological: BloodPatients will be injected by autologous blood at the edge of actively bleeding ulcer |
| Epinephrine injection | Other | Drug: EpinephrinePatients will be injected by diluted epinephrine at the edge of actively bleeding ulcer |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- all adult patients with gastroduodenal ulcer
Key exclusion criteria (4 listed)
- Patients with non ulcer bleeding.
- Patients with malignancy.
- Patients with bleeding disorders or under coagulation therapy.
- Patients with known allergy to epinephrine.
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 |
|---|---|---|
| Epinephrine10-30 cc of 1/10000 diluted epinephrine will be injected at edges of an actively bleeding ulcer. | Drug | Epinephrine injection |
| Blood5-20 cc autologous blood immediately withdrawn from the patient will be injected at edges of the actively bleeding ulcer. | Biological | Autologous blood |
Primary outcome
hemostasis from the ulcer after injection and/or stoppage of haematemesis and melena one day after the procedure.
Time frame: 12 months
1 secondary outcome
development of re-bleeding after 24 hours after the procedure (occurrence of hematemesis or melena or drop of hemoglobin level >2gm/dl).
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2013.
- Our Department official journalLink provided by the sponsor.
- Our HospitalLink provided by the sponsor.
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Syncope, Vasovagal, Blood, Injection, Injury Type Phobia
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.
Mohamed H Emara, MD principal investigator
Tropical Medicine Department, Faculty of Medicine, Zagazig University, Zagazig, 44519, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epinephrine and Blood in people with Blood, Injection, Injury Type Phobia and Gastrointestinal Ulcer Haemorrhage, run by Zagazig University at 1 site in Egypt.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 25 Sep 2013. 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 Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
hemostasis from the ulcer after injection and/or stoppage of haematemesis and melena one day after the procedure. (time frame: 12 months). 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 25 Sep 2013.