Study comparing two anticoagulation drucgs, bemiparin and warfarin, in patients who have had gastrointestinal bleeding and need for his illness to be anticoagulated

Randomized controlled trial to compare treatment with oral anticoagulation with vitamin K antagonists versus low molecular weight heparin (bemiparin) in patients with anticoagulation criteria and have an episode of gastrointestinal bleeding. - HEPACO

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-006887-12-ES

Enrollment

Unknown

Registered

2011-09-15

Start date

2011-12-07

Completion date

Unknown

Last updated

2016-08-16

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

Conditions

Patients with gastrointestinal bleeding are not candidates for endoscopic treatment with oral anticoagulant previously.

Interventions

Trade Name: HIBOR 7.500 UI Pharmaceutical Form: Solution for injection INN or Proposed INN: BEMIPARINA SODICA Other descriptive name: BEMIPARINA SODICA Concentration unit: IU international unit(s) Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with anticoagulant therapy criteria (acenocoumarol or warfarin-treated) and high or very high risk embolism, which have had an acute gastrointestinal bleeding (low or high) not amenable to endoscopic treatment, vascular lesions secondary to multiple diverticular origin, or with not clear origen (after gastroscopy and colonoscopy) that have no exclusion criteria. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: A) under 18 years. B) pregnancy. C) patient refusal to participate in the study. D) patients who took the decision not to provide active treatment for the existence of any clinical condition considered terminal (severe associated diseases evolved). E) LMWH contraindication (allergy, heparin-induced thrombocytopenia). F) bleeding secondary to esophageal varices and / or gastric ulcers. G) bleeding associated with peptic injury. H) bleeding secondary to tumors or polyps. i) Presence of portal hypertension with or without liver cirrhosis. J) bleeding due to Mallory-Weiss syndrome. K) anticoagulation low risk for injury embolism.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess whether the substitution therapy with vitamin K antagonists by molecular-weight heparin (bemiparin) in patients who have had an episode of gastrointestinal bleeding and who have indications for anticoagulation is associated with a decreased incidence of recurrent gastrointestinal bleeding.;Secondary Objective: - Incidencia de episodios tromboembólicos - Hemorragias en otras localizaciones - Severidad de los episodios de recurrencia hemorrágica - Necesidades transfusionales - Identificación de factores de riesgo asociados - Mortalidad;Primary end point(s): Digestive bleeding incidence;Timepoint(s) of evaluation of this end point: 2 years	—

Measure

Time frame

Main Objective: To assess whether the substitution therapy with vitamin K antagonists by molecular-weight heparin (bemiparin) in patients who have had an episode of gastrointestinal bleeding and who have indications for anticoagulation is associated with a decreased incidence of recurrent gastrointestinal bleeding.;Secondary Objective: - Incidencia de episodios tromboembólicos - Hemorragias en otras localizaciones - Severidad de los episodios de recurrencia hemorrágica - Necesidades transfusionales - Identificación de factores de riesgo asociados - Mortalidad;Primary end point(s): Digestive bleeding incidence;Timepoint(s) of evaluation of this end point: 2 years

—

Secondary

Measure	Time frame
Secondary end point(s): - Mortality - Severity of the recurrence - Incidence tromboembolism - Asotiation with AINEs, aspirin AAs or other antiagregants. - Complications of treatment;Timepoint(s) of evaluation of this end point: 2 years	—

Countries

Spain

Contacts

Public ContactRomy Rodríguez

Institut de Recerca HSCSP

RRodriguezMu@santpau.cat003429190001969

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026