Contact information
Type
Scientific
Primary contact
Dr Anne-Sophie Ducloy-Bouthors
ORCID ID
Contact details
Pole anesthesie reanimation
maternite Jeanne de Flandre
CHRU
Lille
59037
France
+33 (0)3 20 44 63 15
asducloy@neuf.fr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PHRC 2004 1915
Study information
Scientific title
A multi-centre open-label randomised controlled trial measuring the efficacy of tranexamic acid to reduce post partum haemorrhage volume
Acronym
EXADELI
Study hypothesis
A high dose tranexamic acid (TA) reduces a strictly measured ongoing Post-Partum Haemorrhage (PPH) volume.
Ethics approval
Ethics committee of the University Hospital of Lille, 04/01/2005
Study design
Multi-centre randomised controlled open-label study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Post-partum haemorrhage
Intervention
Immediately after inclusion, patients were randomised to receive either TA (TA group) or no antifibrinolytic treatment (control group). The randomisation sequence was generated by a centralised computer and randomisation was balanced by centre. In the TA group, a dose of 4 grams of TA was mixed with 50 mL of normal saline and administered intravenously over an one-hour period. After the loading dose infusion, a maintenance infusion of 1g/hour was initiated and maintained for six hours.
Intervention type
Drug
Phase
Not Applicable
Drug names
Tranexamic acid
Primary outcome measures
The volume of blood loss between enrollment and 6 hours later
Secondary outcome measures
1. Duration of bleeding and the impact of TA on PPH-related outcome [decrease in haemoglobin concentration, transfusion of packed red blood cells (PRBC) at T4 and at day 42, and the need for invasive procedures (uterine artery embolisation or ligature, hysterectomy), late post-partum curettage or general outcome (intensive care unit stay, use of any vasopressors, dyspnoea, renal and multiple organ failure)].
2. Severe PPH was defined according to Charbit et al. as exhibiting one of the following criteria:
2.1. Peri-partum decrease of haemoglobin > 4g/dL, with the last haemoglobin value before delivery considered as the reference
2.2. Transfusion of at least four packed red blood cells (PRBC)
2.3. Invasive haemostatic intervention
2.4. Death
Evaluation of each endpoint was performed by investigators blinded to treatment allocation.
3. Side effects: Although the study was not powered to address safety issues, side effects that could be related to TA were analysed. Major (thrombotic events, renal failure, seizures) and minor side effects were reported at each time point and at day 42. With respect to venous thrombosis, clinical signs of superficial or deep thrombosis were collected and ultrasonography was performed, as soon as the signs were detected.
Overall trial start date
01/05/2005
Overall trial end date
01/05/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Patients were included in the study when PPH was more than 800 mL
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
144
Participant exclusion criteria
1. Age < 18 years
2. Asence of informed consent
3. Caesarean section
4. Presence of known haemostatic abnormalities before pregnancy
5. History of previous thrombosis or epilepsy
Recruitment start date
01/05/2005
Recruitment end date
01/05/2008
Locations
Countries of recruitment
France
Trial participating centre
Pole anesthesie reanimation
Lille
59037
France
Sponsor information
Organisation
University Hospital Research Delegation of Lille (France)
Sponsor details
2 Avenue Oscar Lambret
Lille
59037
France
+33 (0)3 20 44 59 62
valerie.santraine@chru-lille.fr
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
French Ministry of Health (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21496253
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27106967
Publication citations
-
Results
Ducloy-Bouthors AS, Jude B, Duhamel A, Broisin F, Huissoud C, Keita-Meyer H, Mandelbrot L, Tillouche N, Fontaine S, Le Goueff F, Depret-Mosser S, Vallet B, , Susen S, High-dose tranexamic acid reduces blood loss in postpartum haemorrhage., Crit Care, 2011, 15, 2, R117, doi: 10.1186/cc10143.
-
Results
Ducloy-Bouthors AS, Duhamel A, Kipnis E, Tournoys A, Prado-Dupont A, Elkalioubie A, Jeanpierre E, Debize G, Peynaud-Debayle E, DeProst D, Huissoud C, Rauch A, Susen S, Postpartum haemorrhage related early increase in D-dimers is inhibited by tranexamic acid: haemostasis parameters of a randomized controlled open labelled trial, Br J Anaesth, 2016 , 116, 5, 641-648, doi: 10.1093/bja/aew021.