NCT02091479: RATHER

Randomized Assay Evaluating the Risk/Benefit of Early Versus Late Resumption of Anticoagulation in Patients With Major, Non-trauma Related Hemorrhage Occurring While on Anticoagulant Treatment for a High Risk of Thrombosis.

Terminated Phase 3 Last updated 9 March 2016

What this trial tests

Phase 3 trial testing UFH Early group in Major hæmorrhage in 14 participants. Terminated before completion.

Timeline

1 January 2013

Primary endpoint
1 June 2015

1 June 2015

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Saint Etienne
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	14
Start date	1 January 2013
Primary completion	1 June 2015
Estimated completion	1 June 2015
Sites	2 locations across France

Drugs / interventions tested

• UFH Early group — full drug profile →
• UFH Late group — full drug profile →

Conditions studied

• Major hæmorrhage — all drugs for Major hæmorrhage →

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Who can join

Adults 18 to 90, any sex, with Major hæmorrhage. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The main criterion in this study is the cumulated incidence of mortality, hæmorrhage recurrence and thromboembolic complications at 1 month
  Time frame: The main criterion in this study is the cumulated incidence of mortality, hæmorrhage recurrence and thromboembolic complications at 1 month
  Fatal hæmorrhage proven by autopsy or sudden deaths in a clinical context strongly suggestive of hæmorrhage, * Fatal thromboembolic events proven by autopsy or imagery or sudden deaths in a clinical context strongly suggestive of thrombosis, * Any clinically significant hæmorrhage leading to temporary (\> 24 hours) or permanent withdrawal of anticoagulant treatment, * Any symptomatic thromboembol

Sponsor's own description

In patients with a high thromboembolic risk, withdrawing anticoagulant treatment is recommended in some situations, including when major hæmorrhage occurs. But withdrawing treatment can be risky. In patients on a curative dose of anticoagulant medicine, treatment withdrawal heightens the risk of thromboembolic events occurring, with potentially major consequences. For instance, mechanical valve thrombosis is fatal in 15% of patients. Resumption of anticoagulation is therefore critical in patients at high risk for thromboembolic events.

However, in these patients having presented major hæmorrhage, resumption of anticoagulation heightens the risk of hæmorrhage recurrence. This risk is even higher when the original hæmorrhage was not accessible via surgical, endoscopic or endoluminal hemostasis.

As far as investigators know, there is no data in the literature to rely on when the major hæmorrhage is not accessible via hemostatic intervention and the risk of thrombosis is high. When confronted with patients who need anticoagulation but have a high risk of hæmorrhage recurrence, the question of when treatment should be resumed has not been resolved. This is why investigators propose to conduct a randomised comparative study to evaluate two treatment strategies - early resumption (H48 to H72) versus late resumption (H120 to H144) of anticoagulation.

MAIN OBJECTIVE: The main objective of the present study is to evaluate in terms of bleeding risk, thrombosis risk and mortality at one month, the effect of early vs. late resumption of anticoagulation in patients having presented with serious hæmorrhage while on curative-dose anticoagulants and facing a high thromboembolic risk.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.