Platelet Rich Plasma in Bleeding Peptic Ulcer

NCT03733171 | Unknown

• 1 other identifier: 4940
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Bleeding Ulcer

Keywords

platelet rich plasma

Outcome Measures

Primary Outcomes (1)

• bleeding

  control of peptic ulcer bleeding

  3 months

Secondary Outcomes (1)

• improved iron indices

  3 months

Study Arms (2)

Platelet rich plasma

ACTIVE COMPARATOR

endoscopic injection of PRP

Drug: PLATELET RICH PLASMA

CONTROL GROUP

PLACEBO COMPARATOR

diluted epinephrine

Drug: diluted epinephrine; Device: hemoclips

Interventions

PLATELET RICH PLASMA DRUG

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

Platelet rich plasma

diluted epinephrine DRUG

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

CONTROL GROUP

hemoclips DEVICE

diluted epinephrine was injected followed by application of hemoclips

Also known as: mechanical hemostasis

CONTROL GROUP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have a peptic ulcer with either actively bleeding or a non-bleeding visible vessel
• initial hemoglobin concentration of \< 10 g/dL

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University

Zagazig, Sharqia Province, 44519, Egypt

RECRUITING

Related Publications (1)

• 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.

  PMID: 34030430 DERIVED

MeSH Terms

Interventions

Hemostasis

Intervention Hierarchy (Ancestors)

Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• WASEEM SELEEM, MD

  zagazig university hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Waseem Seleem, MD

CONTACT

+201026258004; WASEEMMOHAMED1975@GMAIL.COM

Amr Hanafy, md

CONTACT

+201100061861; dr_amr_hanafy@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of medicine

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 7, 2018
• Study Start: September 20, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 30, 2019
• Last Updated: June 7, 2019

Record last verified: 2019-06

Locations

EG (1)