Platelet Rich Plasma in Bleeding Peptic Ulcer

Bleeding Ulcer Clinical Trial

— PRP  

Official title:

Role of Platelet Rich Plasma in the Treatment of Actively Bleeding Peptic Ulcer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03733171
• Other study ID #: 4940
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: June 2019
• Source: Zagazig University
• Contact: Waseem Seleem, MD
• Phone: +201026258004
• Email: WASEEMMOHAMED1975[@]GMAIL.COM
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bleeding Ulcer
• Hemorrhage
• Peptic Ulcer
• Peptic Ulcer Hemorrhage
• Ulcer

Intervention

Drug:
• PLATELET RICH PLASMA
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
• 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

Device:
• hemoclips
diluted epinephrine was injected followed by application of hemoclips

Locations

Country	Name	City	State
Egypt	Zagazig University	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bleeding	control of peptic ulcer bleeding	3 months
Secondary	improved iron indices	imroved complete blood count element	3 months