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Hemostasis by Endoscopy based on Appropriate Timing for UPper gi bleeding study

Hemostasis by Endoscopy based on Appropriate Timing for UPper gi bleeding study - HEAT UP study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000054980
Enrollment
1070
Registered
2024-07-19
Start date
2024-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper gastrointestinal bleeding

Interventions

Waiting group for endoscopy 6-24 hours from the time of consultation with the gastroenterologist Emergency group for endoscopy within 6 hours from the time of consultation with the gastroenterologist

Sponsors

Keio University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with suspected upper gastrointestinal bleeding Patients with a HARBINGER of 2 or 3

Exclusion criteria

Exclusion criteria: (i) Persistent fresh hematemesis or hematochezia after consultation with a gastroenterologist (ii) Patients with blood pressure less than 90 mmHg at study entry (patients with blood pressure less than 90 mmHg before entry but recovered by transfusion etc. are not excluded) (iii) Unable to obtain the patient's consent (e.g., impaired consciousness or dementia) (iv) Medically-induced bleeding (e.g., after ESD, EMR, or biopsy) (v) Pregnant women (vi) Patients with terminal cancer whose prognosis is expected to be within 3 months (regardless of carcinoma) (vii) Patients who are judged to be unsuitable by the treating physician

Design outcomes

Primary

MeasureTime frame
Incidence of further bleeding (bleeding that cannot be stopped by endoscopy or rebleeding once hemostasis is confirmed) within 30 days

Secondary

MeasureTime frame
Further bleeding (within 7 and 30 days of allocation) Bleeding not stopped by initial endoscopy Rate of initial endoscopic procedures Rebleeding rate (within 7 and 30 days of allocation) Transfusion rate, transfusion units (within 30 days of allocation) Hemostatic angiography rate (within 30 days of allocation) Hemostatic surgery rate (within 30 days of allocation) All-cause mortality (within 30 days of allocation) Hospitalization days Number of days spent in intensive care units (ICUs, HCUs, critical care centers, etc.) Cost Adverse events (from allocation to endoscopy and within 30 days)

Countries

Japan

Contacts

Public ContactMasayasu Horibe

Keio University School of Medicine Division of Gastroenterology and Hepatology, Department of Internal Medicine

masayasu.horibe@gmail.com0353633790

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026