Condition category
Pregnancy and Childbirth
Date applied
19/02/2011
Date assigned
24/03/2011
Last edited
04/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://chru-lille.fr

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

  1. 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.

  2. 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.

Additional files

Editorial Notes

04/05/2016: Publication reference added.