ClinicalTrials.gg
Status unknownNCT03733171PRPUpdated Jun 7, 2019

Platelet Rich Plasma in Bleeding Peptic Ulcer

An interventional study of PLATELET RICH PLASMA and diluted epinephrine in Bleeding Ulcer, sponsored by Zagazig University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-06-07.

Sponsored by Zagazig University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Bleeding Ulcer

Keywords

  • platelet rich plasma
03

In context

Lead sponsor

Zagazig University is the lead sponsor of 457 studies on the registry; 77 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    Platelet rich plasma

    endoscopic injection of PRP

    Drug: PLATELET RICH PLASMA

  • Placebo comparator
    CONTROL GROUP

    diluted epinephrine

    Drug: diluted epinephrine · Device: hemoclips

Interventions

  • 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

    Also known as: PRP

  • Drugdiluted 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

    Also known as: Hemostasis

  • Devicehemoclips

    diluted epinephrine was injected followed by application of hemoclips

    Also known as: mechanical hemostasis

06

What researchers measure

Primary outcomes

  1. bleeding

    control of peptic ulcer bleeding

    Time frame: 3 months

Secondary outcomes

  1. improved iron indices

    imroved complete blood count element

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 34030430 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03733171
Lead sponsor
Zagazig University
Responsible party
Amr Shaaban Hanafy (Assistant professor of medicine, Zagazig University) — Principal investigator
First posted
Nov 7, 2018
Start date
Sep 20, 2018
Primary completion
Jun 1, 2019 (estimated)
Completion
Jun 30, 2019 (estimated)
Last update
Jun 7, 2019

Study contacts

Waseem Seleem, MD
Contact
WASEEMMOHAMED1975@GMAIL.COM
+201026258004
Amr Hanafy, md
Contact
dr_amr_hanafy@yahoo.com
+201100061861
WASEEM SELEEM, MD
principal investigator · zagazig university hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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