Hemorrhage Clinical Trial
Official title:
Comparison of High Dose Infusion and Low Dose Bolus Intravenous Omeprazole for Treatment of Bleeding Ulcer With Adherent Clot
Verified date | August 2010 |
Source | Far Eastern Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Department of Health |
Study type | Interventional |
The investigators will include those patients with adherent clot on gastric or duodenal
ulcers after endoscopic confirmation After receiving well explanation and giving written
consent, they are enrolled and will be allocated to 2 groups randomly. Those in the first
group will receive intravenous omeprazole 40 mg stat and then 40 mg q12h. Those in the
second group will receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion. The
patients in both groups will receive intravenous omeprazole for 3 days and then oral
esomeprazole qd for further treatment of peptic ulcer.
The investigators define rebleeding during admission and within 30 days as primary end
points and define surgical intervention for ulcer bleeding, transfusion amount and
hospitalization days after allocation as secondary end points.
Status | Completed |
Enrollment | 40 |
Est. completion date | July 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - We will include those patients with adherent clot, more than 5 mm, on gastric or duodenal ulcers after endoscopic confirmation and exclusion of other possible bleeder. Adherent clot is defined that still stays on the ulcer after 200 ml normal saline irrigation (4 times of irrigation with 50 ml syringe). Exclusion Criteria: - ulcer with active bleeding, suspected malignant ulcer, patients with age less than 18 years old, or allergy to omeprazole |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Far Eastern Memorial Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Far Eastern Memorial Hospital |
Taiwan,
Bleau BL, Gostout CJ, Sherman KE, Shaw MJ, Harford WV, Keate RF, Bracy WP, Fleischer DE. Recurrent bleeding from peptic ulcer associated with adherent clot: a randomized study comparing endoscopic treatment with medical therapy. Gastrointest Endosc. 2002 Jul;56(1):1-6. — View Citation
Consensus conference: Therapeutic endoscopy and bleeding ulcers. JAMA. 1989 Sep 8;262(10):1369-72. Review. — View Citation
Jensen DM, Kovacs TO, Jutabha R, Machicado GA, Gralnek IM, Savides TJ, Smith J, Jensen ME, Alofaituli G, Gornbein J. Randomized trial of medical or endoscopic therapy to prevent recurrent ulcer hemorrhage in patients with adherent clots. Gastroenterology. 2002 Aug;123(2):407-13. — View Citation
Jung HK, Son HY, Jung SA, Yi SY, Yoo K, Kim DY, Moon IH, Lee HC. Comparison of oral omeprazole and endoscopic ethanol injection therapy for prevention of recurrent bleeding from peptic ulcers with nonbleeding visible vessels or fresh adherent clots. Am J Gastroenterol. 2002 Jul;97(7):1736-40. — View Citation
Kahi CJ, Jensen DM, Sung JJ, Bleau BL, Jung HK, Eckert G, Imperiale TF. Endoscopic therapy versus medical therapy for bleeding peptic ulcer with adherent clot: a meta-analysis. Gastroenterology. 2005 Sep;129(3):855-62. Erratum in: Gastroenterology. 2006 Sep;131(3):980-1. — View Citation
Katschinski B, Logan R, Davies J, Faulkner G, Pearson J, Langman M. Prognostic factors in upper gastrointestinal bleeding. Dig Dis Sci. 1994 Apr;39(4):706-12. — View Citation
Laine L, Freeman M, Cohen H. Lack of uniformity in evaluation of endoscopic prognostic features of bleeding ulcers. Gastrointest Endosc. 1994 Jul-Aug;40(4):411-7. — View Citation
Laine L, Peterson WL. Bleeding peptic ulcer. N Engl J Med. 1994 Sep 15;331(11):717-27. Review. — View Citation
Lau JY, Leung WK, Wu JC, Chan FK, Wong VW, Chiu PW, Lee VW, Lee KK, Cheung FK, Siu P, Ng EK, Sung JJ. Omeprazole before endoscopy in patients with gastrointestinal bleeding. N Engl J Med. 2007 Apr 19;356(16):1631-40. — View Citation
Lau JY, Sung JJ, Chan AC, Lai GW, Lau JT, Ng EK, Chung SC, Li AK. Stigmata of hemorrhage in bleeding peptic ulcers: an interobserver agreement study among international experts. Gastrointest Endosc. 1997 Jul;46(1):33-6. — View Citation
Lin HJ, Lo WC, Cheng YC, Perng CL. Role of intravenous omeprazole in patients with high-risk peptic ulcer bleeding after successful endoscopic epinephrine injection: a prospective randomized comparative trial. Am J Gastroenterol. 2006 Mar;101(3):500-5. — View Citation
Martins NB, Wassef W. Upper gastrointestinal bleeding. Curr Opin Gastroenterol. 2006 Nov;22(6):612-9. Review. — View Citation
Rollhauser C, Fleischer DE. Nonvariceal upper gastrointestinal bleeding. Endoscopy. 2004 Jan;36(1):52-8. Review. — View Citation
Sheu BS, Chi CH, Huang CC, Kao AW, Wang YL, Yang HB. Impact of intravenous omeprazole on Helicobacter pylori eradication by triple therapy in patients with peptic ulcer bleeding. Aliment Pharmacol Ther. 2002 Jan;16(1):137-43. — View Citation
Sung JJ, Chan FK, Lau JY, Yung MY, Leung WK, Wu JC, Ng EK, Chung SC. The effect of endoscopic therapy in patients receiving omeprazole for bleeding ulcers with nonbleeding visible vessels or adherent clots: a randomized comparison. Ann Intern Med. 2003 Aug 19;139(4):237-43. — View Citation
Swain CP, Kirkham JS, Salmon PR, Bown SG, Northfield TC. Controlled trial of Nd-YAG laser photocoagulation in bleeding peptic ulcers. Lancet. 1986 May 17;1(8490):1113-7. — View Citation
Swain CP, Storey DW, Bown SG, Heath J, Mills TN, Salmon PR, Northfield TC, Kirkham JS, O'Sullivan JP. Nature of the bleeding vessel in recurrently bleeding gastric ulcers. Gastroenterology. 1986 Mar;90(3):595-608. — View Citation
* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | rebleeding rate within 30 days after allocation | within 30 days after allocation | Yes | |
Secondary | blood transfusion units needed within 30 days after allocation | within 30 days after allocation | Yes |
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