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Platelet Rich Plasma in Bleeding Peptic Ulcer (PRP)

Primary Purpose

Bleeding Ulcer

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
PLATELET RICH PLASMA
diluted epinephrine
hemoclips
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bleeding Ulcer focused on measuring platelet rich plasma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zagazig UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Platelet rich plasma

CONTROL GROUP

Arm Description

endoscopic injection of PRP

diluted epinephrine

Outcomes

Primary Outcome Measures

bleeding
control of peptic ulcer bleeding

Secondary Outcome Measures

improved iron indices
imroved complete blood count element

Full Information

First Posted
November 5, 2018
Last Updated
June 5, 2019
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT03733171
Brief Title
Platelet Rich Plasma in Bleeding Peptic Ulcer
Acronym
PRP
Official Title
Role of Platelet Rich Plasma in the Treatment of Actively Bleeding Peptic Ulcer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding Ulcer
Keywords
platelet rich plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Platelet rich plasma
Arm Type
Active Comparator
Arm Description
endoscopic injection of PRP
Arm Title
CONTROL GROUP
Arm Type
Placebo Comparator
Arm Description
diluted epinephrine
Intervention Type
Drug
Intervention Name(s)
PLATELET RICH PLASMA
Other Intervention Name(s)
PRP
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
diluted epinephrine
Other Intervention Name(s)
Hemostasis
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
hemoclips
Other Intervention Name(s)
mechanical hemostasis
Intervention Description
diluted epinephrine was injected followed by application of hemoclips
Primary Outcome Measure Information:
Title
bleeding
Description
control of peptic ulcer bleeding
Time Frame
3 months
Secondary Outcome Measure Information:
Title
improved iron indices
Description
imroved complete blood count element
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Waseem Seleem, MD
Phone
+201026258004
Email
WASEEMMOHAMED1975@GMAIL.COM
First Name & Middle Initial & Last Name or Official Title & Degree
Amr Hanafy, md
Phone
+201100061861
Email
dr_amr_hanafy@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WASEEM SELEEM, MD
Organizational Affiliation
zagazig university hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zagazig University
City
Zagazig
State/Province
Sharkia
ZIP/Postal Code
44519
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Waseem Seleem, md
Phone
+201025264008
Email
waseemmohamed1975@gmail.com
First Name & Middle Initial & Last Name & Degree
Amr Hanafy, md
Phone
+201100061861
Email
dr_amr_hanafy@yahoo.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
34030430
Citation
Seleem WM, Hanafy AS. The Additive Effect of Platelet-Rich Plasma in the Treatment of Actively Bleeding Peptic Ulcer. Clin Endosc. 2021 Nov;54(6):864-871. doi: 10.5946/ce.2021.004. Epub 2021 May 25.
Results Reference
derived

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Platelet Rich Plasma in Bleeding Peptic Ulcer

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