NCT02618980

Brief Summary

The primary aim of this study is to compare efficacy of "early endoscopy" and "non-endoscopic treatment" for management of acute upper gastrointestinal (UGI) bleeding in patients with recent acute coronary syndrome (ACS). This study will also compare rates of surgery, repeated intervention (endoscopy or TAE), rebleeding and complications between two groups.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

December 20, 2021

Status Verified

December 1, 2021

Enrollment Period

7 years

First QC Date

November 21, 2015

Last Update Submit

December 4, 2021

Conditions

Gastrointestinal Bleeding

Keywords

acute coronary syndromegastrointestinal bleedingendoscopy

Outcome Measures

Primary Outcomes (1)

  • Failure of control hemorrhage

    Hematemesis or nasogastric tube drainage of significant fresh blood (≧200 mL) ≧2hours after a specific treatment (therapeutic endoscopy, medical control, transarterial embolization (TAE) or surgery); or Persistent hypovolemic shock; or 3 g/dl drop in Hb level (or 9% drop of Hct) within 24 hours if no transfusion is administered; or A decrease in Hb greater than 2 g/dL or an increase in Hb less than 1 g/dL, despite 2 or more units of blood transfused within 24 hours.

    24 hours

Secondary Outcomes (5)

  • Complication rates

    24 hours

  • length of hospital stay

    14 days

  • units of blood transfusion

    24 hours

  • re-bleeding rate

    72 hours

  • needs for repeated intervention

    72 hours

Study Arms (2)

early endoscopy

EXPERIMENTAL

endoscopic hemostasis

Other: endoscopic hemostasis

without early endoscopy

NO INTERVENTION

Patients assigned to non-endoscopic treatment group receive high dose infusional PPI therapy. If UGI bleeding subsided after medical treatment alone, diagnostic EGD will be done under stable hemodynamic and 2 weeks after ACS to confirm UGI SRH. If the SRH is not located at UGI tract, the patients will be excluded. Troponin I or T and complete ECG will be checked every 8 hours within 24 hours of interventions. APACHE II score at intervention will be calculated for each patient.

Interventions

endoscopic hemostasisOTHER

At endoscopy, stigmata of hemorrhage (SRH) will be treated by dual endoscopic local therapy (combining at least two of the following treatments: epinephrine injection, coaptive thermocoagulation, hemoclip therapy, argon plasma coagulation, bipolar coagulation).

early endoscopy

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with recent (\< 2 weeks) ACS and acute upper GI bleeding accompanied with a decrease in hemoglobin (Hb) level greater than 2 g/dl

You may not qualify if:

  • Malignancy or other advanced disease with a life expectancy of \< 6 months
  • Pregnant or lactating women
  • History of allergy or severe side effects to PPIs, contrast, and iodine
  • Bleeding tendency, and platelet count \< 80k/uL, prothrombin time INR \>2.0
  • Decompensated liver cirrhosis (Child-Pugh classification B\~C) and esophagogastric varices history
  • Stage 3\~5 CKD (estimated Ccr \< 60 ml/min/1.73m2) using Cockcroft-Gault formula, exclusive of end-stage renal disease under renal replacement therapy
  • Stigmata of hemorrhage confirmed as lower GI tract bleeders
  • Without informed consents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, Taiwan

Location

Related Publications (1)

  • Chung CS, Chen CC, Chen KC, Fang YJ, Hsu WF, Chen YN, Tseng WC, Lin CK, Lee TH, Wang HP, Wu YW. Randomized controlled trial of early endoscopy for upper gastrointestinal bleeding in acute coronary syndrome patients. Sci Rep. 2022 Apr 6;12(1):5798. doi: 10.1038/s41598-022-09911-5.

    PMID: 35388113DERIVED

MeSH Terms

Conditions

Gastrointestinal HemorrhageAcute Coronary Syndrome

Interventions

Hemostasis, Endoscopic

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Hemostatic TechniquesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

November 21, 2015

First Posted

December 2, 2015

Study Start

July 1, 2014

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

December 20, 2021

Record last verified: 2021-12

Locations

TW(1)