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
Scientific
Pole anesthesie reanimation
maternite Jeanne de Flandre
CHRU
Lille
59037
France
| Phone | +33 (0)3 20 44 63 15 |
|---|---|
| asducloy@neuf.fr |
Study information
| Study design | Multi-centre randomised controlled open-label study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A multi-centre open-label randomised controlled trial measuring the efficacy of tranexamic acid to reduce post partum haemorrhage volume |
| Study acronym | EXADELI |
| Study objectives | A 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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Tranexamic acid |
| Primary outcome measure | 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 study start date | 01/05/2005 |
| Completion date | 01/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 144 |
| Key inclusion criteria | Patients were included in the study when PPH was more than 800 mL |
| Key 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 |
| Date of first enrolment | 01/05/2005 |
| Date of final enrolment | 01/05/2008 |
Locations
Countries of recruitment
- France
Study participating centre
Pole anesthesie reanimation
Lille
59037
France
59037
France
Sponsor information
University Hospital Research Delegation of Lille (France)
Hospital/treatment centre
Hospital/treatment centre
2 Avenue Oscar Lambret
Lille
59037
France
| Phone | +33 (0)3 20 44 59 62 |
|---|---|
| valerie.santraine@chru-lille.fr | |
| Website | http://chru-lille.fr |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
