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临床试验/NCT03733171
NCT03733171Unknown不适用

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

Zagazig University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年9月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
bleeding

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Platelet rich plasma

Active Comparator

endoscopic injection of PRP

干预措施: PLATELET RICH PLASMA (Drug)

CONTROL GROUP

Placebo Comparator

diluted epinephrine

干预措施: diluted epinephrine (Drug)

CONTROL GROUP

Placebo Comparator

diluted epinephrine

干预措施: hemoclips (Device)

结局指标

主要结局

bleeding

时间窗: 3 months

control of peptic ulcer bleeding

次要结局

  • improved iron indices(3 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Amr Shaaban Hanafy

Assistant professor of medicine

Zagazig University

研究点 (1)

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