A study to measure the efficacy of tranexamic acid to reduce post partum haemorrhage volume

ISRCTN ISRCTN09968140
DOI https://doi.org/10.1186/ISRCTN09968140
Secondary identifying numbers PHRC 2004 1915
Submission date
19/02/2011
Registration date
24/03/2011
Last edited
04/05/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Anne-Sophie Ducloy-Bouthors
Scientific

Pole anesthesie reanimation
maternite Jeanne de Flandre
CHRU
Lille
59037
France

Phone +33 (0)3 20 44 63 15
Email asducloy@neuf.fr

Study information

Study designMulti-centre randomised controlled open-label study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA multi-centre open-label randomised controlled trial measuring the efficacy of tranexamic acid to reduce post partum haemorrhage volume
Study acronymEXADELI
Study objectivesA high dose tranexamic acid (TA) reduces a strictly measured ongoing Post-Partum Haemorrhage (PPH) volume.
Ethics approval(s)Ethics committee of the University Hospital of Lille, 04/01/2005
Health condition(s) or problem(s) studiedPost-partum haemorrhage
InterventionImmediately 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Tranexamic acid
Primary outcome measureThe volume of blood loss between enrollment and 6 hours later
Secondary outcome measures1. 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 study start date01/05/2005
Completion date01/05/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants144
Key inclusion criteriaPatients were included in the study when PPH was more than 800 mL
Key exclusion criteria1. 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
Date of first enrolment01/05/2005
Date of final enrolment01/05/2008

Locations

Countries of recruitment

  • France

Study participating centre

Pole anesthesie reanimation
Lille
59037
France

Sponsor information

University Hospital Research Delegation of Lille (France)
Hospital/treatment centre

2 Avenue Oscar Lambret
Lille
59037
France

Phone +33 (0)3 20 44 59 62
Email valerie.santraine@chru-lille.fr
Website http://chru-lille.fr
ROR logo "ROR" https://ror.org/02ppyfa04

Funders

Funder type

Government

French Ministry of Health (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2011 Yes No
Results article results 01/05/2016 Yes No

Editorial Notes

04/05/2016: Publication reference added.