Compare VKA vs LMWH in Patients With Anticoagulation Criteria and Episode of Gastrointestinal Bleeding. (HEPACO)
1.0. Type of Application: Clinical trial comparing two treatments in terms of authorized use.
1.1. Promoter: Institute of Research, Hospital de la Santa Creu i Sant Pau. Avgda. Sant Antoni M.Claret, 167. 08025 Barcelona. Tel: (34) 93 291 9140/93 291 21 73.
1.2. Title: Randomized controlled trial to compare treatment with oral anticoagulation with antagonists of vitamin K versus low molecular weight heparin (Bemiparin) in patients with anticoagulation criteria and who have had an episode of gastrointestinal bleeding.
1.3. Protocol code: HEPACO 1.4. Principal Investigators: Dr. Candid Villanueva Sanchez. Dr. Jose Mateo Arranz. Contributors: Dr. Alicia Brotons (Service of Digestive Pathology), Dr. Angela Puente (service of Digestive Pathology), Dr. Isabel Graupera (Service of Digestive Pathology) and Dr. Marina Carrasco (Hematology Service). Hospital de la Santa Creu i Sant Pau. Avgda. Sant Antoni Maria Claret, 167. 08025 Barcelona. Tel: (34) 93 291 91 39. Fax: (34) 93 291 92 78.
E-mail: firstname.lastname@example.org. 1.5. Centers that are planned for the trial: Service Gastroenterology and Hematology Service of the Sant Creu i Sant Pau, Barcelona.
1.6. Clinical Research Ethics Committee: Hospital de la Santa Creu i Sant Pau. 1.7. Monitor: Institute for Research (CAIBER) of the Hospital de Sant Pau. Avgda. Sant Antoni M.Claret, 167. 08025 Barcelona. Tel: (34) 93 291 9140.
1.8. Drugs: warfarin, bemiparin. 1.9. Development stage: Clinical Trial phase IV 1.10. Main objective: To compare the incidence of gastrointestinal rebleeding and safety of oral anticoagulation versus low molecular weight heparin in patients who have had an acute gastrointestinal bleeding and have indication for anticoagulation.
1.11. Design: prospective open clinical trial, randomized and controlled. 1.12. Study disease: acute gastrointestinal bleeding. 1.13. Primary endpoint of the valoration: Incidence of gastrointestinal bleeding.
1.14. Study population and total number of patients: 20 patients were required in each group (40 total) to objectify a decrease of rebleeding rate of 45% with an alpha error of 5% and 10% beta.
1.15. Treatment duration: 2 years. 1.16. Calendar and expected completion date: July 2011 - July 2013
|Acute Gastrointestinal Bleeding||Drug: warfarin Drug: Bemiparina||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Controlled Trial to Compare Treatment With Oral Anticoagulation With Antagonists of vitaminK vs Low Molecular Weight Heparin(Bemiparin) in Patients With Anticoagulation Criteria and an Episode of Gastrointestinal Bleeding.|
- Rebleeding [ Time Frame: 1 year ]upper or lower gastrointestinal bleeding in the follow-up period in both groups.
- thromboembolic events [ Time Frame: 1 year ]
- Mortality: [ Time Frame: 1 year ]
We included all deaths in this period whatever the reason immediately. Shall specify the date of death to calculate the actuarial probability curves. This will be considered as time 0, the entry in the first hospital where the patient go, or the first bleeding sign if the patient were hospitalized.
where and when they were admitted first symptom of bleeding.
- Severity of rebleeding [ Time Frame: 1 year ]TA, FC, low Hb, transfusion requirements).
- Association with NSAIDs, aspirin or other antiplatelet agents. [ Time Frame: 1 year ]
- treatment complications. [ Time Frame: 1 year ]It will collect any adverse events observed during follow-up, either initially or not attributable to treatment. Notification of serious adverse events and unexpected will be modeled and general instructions contained in Royal Decree 223/2004 of 6 February laying down the requirements for conducting clinical drug trials
- Time of hospitalization [ Time Frame: 1 year ]Time of hospitalization during follow-up.
- Number of hospitalizations during follow-up. [ Time Frame: 1 year ]
|Study Start Date:||December 2011|
|Study Completion Date:||September 2015|
|Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Bemiparin
Group 1 (low molecular weight heparin: bemiparin), which is the study group: after passing the bleeding episode, will receive low molecular weight heparin (bemiparin) in anticoagulant dose. Check should be made by measurement of anti-factor Xa.
Group 2 (VKA oral anticoagulation: warfarin), which is the control group will receive VKA anticoagulation as before they had the bleeding episode, with regular monitoring by measurement of prothrombin time (INR). Patients taking acenocoumarol before bleeding episode will be treated with warfarin and the once who were receiving warfarin will continue with the same treatment. Treatment control is performed by measuring the INR periodically.
Randomization will be performed using sealed opaque envelopes that contain the treatment option that will be obtained through a list of random numbers generated by computer.
Active Comparator: Warfarin
which is the control group will receive VKA anticoagulation as before they had the bleeding episode, with regular monitoring by measurement of prothrombin time (INR). Patients taking acenocoumarol before bleeding episode will be treated with warfarin and the once who were receiving warfarin will continue with the same treatment. Treatment control is performed by measuring the INR periodically.
Warfarin in anticoagulant dose
Other Name: VKA oral anticoagulationin
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727453
|Hospital de la Santa Creu i Sant Pau|
|Barcelona, Spain, 08025|
|Principal Investigator:||Candido Villanueva, MD||Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau|