- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03733171
Platelet Rich Plasma in Bleeding Peptic Ulcer (PRP)
Role of Platelet Rich Plasma in the Treatment of Actively Bleeding Peptic Ulcer
The most common cause of acute upper gastrointestinal bleeding (UGIB) is non-variceal, where peptic ulcer bleeding (PUB) remains the single most common cause, accounting for 25% to 67% of the causes of non-variceal upper gastrointestinal bleeding (NVUGIB).
Despite major advances in diagnostic and therapeutic tools, PUB remains a significant problem and an important cause of morbidity and mortality. Given the imperative therapeutic role of endoscopic management in achieving hemostasis in NVUGIB, new modalities to improve the current treatment strategies continue to be developed.
Platelet-rich plasma (PRP) is a widely used throughout many fields of medicine for improving tissue regeneration. PRP contains a higher concentration of platelets than whole blood, and represents a pool of many growth-factors.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All patients were subjected to full history taking, complete clinical examination, laboratory investigations (complete blood count, liver and kidney function tests, coagulation profile), ECG and Upper GI endoscopy was performed within 24 hours of hospital admission after initial resuscitation of patients including blood transfusion if HB level ≤ 7g ∕ L.
Stigmata of recent hemorrhage was defined according to the Forrest (F) classification (FIa- spurting hemorrhage, FIb- oozing hemorrhage, FIIa- non-bleeding visible vessel, FIIb- adherent clot, FIIc- flat pigmented spot and FIII- clean base ulcer).The size of an ulcer was classified as < 2 cm or ≥ 2cm.
- PRP or diluted epinephrine were injected in 1-2 ml by multiple injections into and circumferentially around the ulcer until bleeding stopped using a 25-G retractable, standard sclerotherapy needle.
- Group I was subjected to multiple injection of PRP (each 1-2 ml), while group II was subjected to epinephrine injections (each 1-2 ml of a 1:10.000 solution of epinephrine) .
- Hemostasis was achieved if bleeding stopped for at least 3 min of observation. Immediately after the endoscopic hemostasis, PPIs were infused at a standard regimen (40 mg bolus of PPI once daily for 72 h) or at a high-dose regimen (loading dose of 80 mg on the first day followed by continuous infusion of 8 mg/h for 72 h), after the initial 72 h, patients were switched to oral PPIs (20 mg twice daily) until discharge .
PRP preparation method
Under complete aseptic conditions the blood was drawn with the addition of anticoagulant such as citrate dextrose A to prevent platelet activation prior to its use.
1.30-60 cc of patients' blood drawn at the time of treatment by venipuncture in acid citrate dextrose (acts as an anticoagulant) tubes 2. Do not chill the blood. 3. Centrifuge the blood using a 'soft' spin (1st centrifugation). 4. Transfer the supernatant plasma containing platelets into another sterile tube (without anticoagulant).
5. Centrifuge tube at a higher speed (a hard spin) to obtain a platelet concentrate (2nd centrifugation).
6. The lower 1/3rd is PRP and upper 2/3rd is platelet-poor plasma (PPP). At the bottom of the tube, platelet pellets are formed.
7. Remove PPP and suspend the platelet pellets in a minimum quantity of plasma (2-4 mL) by gently shaking the tube.
8.Thrombin (dose) was added to activate PRP
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Waseem Seleem, MD
- Phone Number: +201026258004
- Email: WASEEMMOHAMED1975@GMAIL.COM
Study Contact Backup
- Name: Amr Hanafy, md
- Phone Number: +201100061861
- Email: dr_amr_hanafy@yahoo.com
Study Locations
-
-
Sharkia
-
Zagazig, Sharkia, Egypt, 44519
- Recruiting
- Zagazig University
-
Contact:
- Amr Hanafy, md
- Phone Number: +201100061861
- Email: dr_amr_hanafy@yahoo.com
-
Contact:
- Waseem Seleem, md
- Phone Number: +201025264008
- Email: waseemmohamed1975@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients who have a peptic ulcer with either actively bleeding or a non-bleeding visible vessel
- initial hemoglobin concentration of < 10 g/dL
Exclusion Criteria:
- Patients with non-PUB, coagulopathy, bleeding disorders, anticoagulant therapy, cardiopulmonary compromise, hypertension, ischemic heart disease, arrhythmia, and patients who refused to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Platelet rich plasma
endoscopic injection of PRP
|
PRP was injected in 1-2 ml by multiple injections into and circumferentially around the ulcer until bleeding stopped using a 25-G retractable, standard sclerotherapy needle
Other Names:
|
Placebo Comparator: CONTROL GROUP
diluted epinephrine
|
diluted epinephrine was injected in 1-2 ml by multiple injections into and circumferentially around the ulcer until bleeding stopped using a 25-G retractable, standard sclerotherapy needle
Other Names:
diluted epinephrine was injected followed by application of hemoclips
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
bleeding
Time Frame: 3 months
|
control of peptic ulcer bleeding
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
improved iron indices
Time Frame: 3 months
|
imroved complete blood count element
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: WASEEM SELEEM, MD, Zagazig University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Stomach Diseases
- Intestinal Diseases
- Duodenal Diseases
- Gastrointestinal Hemorrhage
- Ulcer
- Hemorrhage
- Peptic Ulcer
- Peptic Ulcer Hemorrhage
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Coagulants
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Hemostatics
- Epinephrine
Other Study ID Numbers
- 4940
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Bleeding Ulcer
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownBleeding Gastric Ulcer | Bleeding Duodenal UlcerChina
-
Chinese University of Hong KongCompleted
-
Chinese University of Hong KongCompletedGastrointestinal Bleeding | Bleeding Peptic Ulcer | Active BleedingChina
-
Livzon Pharmaceutical Group Inc.Completed
-
Chinese University of Hong KongTerminated
-
Chinese University of Hong KongNational Taiwan University Hospital; Beijing Friendship HospitalRecruitingAspirin | GastroIntestinal BleedingHong Kong
-
Azienda USL ModenaRecruiting
-
Kaohsiung Veterans General Hospital.Completed
-
AstraZenecaCompleted
Clinical Trials on PLATELET RICH PLASMA
-
Stanford UniversityPartnership for Clean CompetitionCompletedRheumatic Diseases | TendinopathyUnited States
-
VivaTech International, Inc.RecruitingOsteoarthritisUnited States
-
Genesis Athens ClinicNational and Kapodistrian University of AthensRecruitingMenopause, Premature | Menopausal Syndrome | Premature Ovarian Failure | Ovarian Failure, Premature | Menopause Related ConditionsGreece
-
Cardenal Herrera UniversityCompletedCarpal Tunnel SyndromeSpain
-
Damascus UniversityCompletedBone ResorptionSyrian Arab Republic
-
Rajavithi HospitalRecruitingAutologous Platelet-rich Plasma Supplement | Sperm Cryopreservation | Post-cryopreserved Sperm Quality | Semen AnalysisThailand
-
Peking University Third HospitalRecruiting
-
Matthew GettmanCompleted
-
Sutherland Medical CenterActive, not recruitingRotator Cuff Tears | Rotator Cuff TendinosisPoland
-
EgymedicalpediaAl-Azhar UniversityCompletedUrinary Incontinence | Stress Urinary IncontinenceEgypt