Trial no.:	PACTR202607785550678	Date of Registration:	29/07/2026
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

The Effect of Haemothorax Auto-Transfusion on Coagulation and Haemostasis (HATCH): A Prospective Self-Controlled Interventional Study

Official scientific title

The Effect of Haemothorax Auto-Transfusion on Coagulation and Haemostasis (HATCH): A Prospective Self-Controlled Interventional Study

Brief summary describing the background and objectives of the trial

Haemothoraces are a common consequence of thoracic trauma. Autotransfusion of pleural blood drained via intercostal catheter has been associated with reduced allogeneic transfusion requirement and is often practised in low- and middle-income countries (LMIC) where there is often no robust or readily available supply of allogeneic blood products. The functional effect of autotransfusion on systemic coagulation in vivo, however, remains poorly characterised. Pleural blood is profoundly incoagulable in isolation but appears hypercoagulable in mixing studies, raising questions about whether autotransfusion may exacerbate or ameliorate trauma-associated coagulopathy. No prospective viscoelastic data exist. This study aims to characterise the effect haemothorax autotransfusion has on thromboelastographic (TEG) parameters in adult trauma patients.

Type of trial

Non-Randomised

Acronym (If the trial has an acronym then please provide)

HATCH

Disease(s) or condition(s) being studied

Injury, Occupational Diseases, Poisoning

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Treatment: Other

Anticipated trial start date

03/08/2026

Actual trial start date

Anticipated date of last follow up

30/11/2026

Actual Last follow-up date

Anticipated target sample size (number of participants)

10

Actual target sample size (number of participants)

Recruitment status

Not yet recruiting

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Single Group	Non-randomised		Allocation Sequence/Code was not concealed	Open-label(Masking Not Used)

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	Haemothorax autotransfusion	A single volume of pleural blood to be auto-transfused, depending on amount drained.	Estimated infusion time is approximately 10 minutes.	In the resuscitation of thoracic trauma, intercostal catheters (ICC) are commonly inserted to manage haemothoraces. It is standard of care in this centre to "auto-transfuse" the drained pleural blood into patients if shocked or felt, in the opinion of the treating clinician, that additional volume resuscitation would be beneficial.	10

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
• Adults aged ≥18 years. • Haemothorax requiring drainage via ICC in the TEU. • A requirement for transfusion of blood products in the opinion of the treating clinician. Transfusion decisions in the TEU are made by senior medical staff based on clinical assessment of haemodynamic status, indicators of end-organ perfusion, and degree of ongoing blood loss; there is no formal protocolised trigger.	• Known pre-existing coagulopathy. • Known use of anticoagulant or antiplatelet medication within 7 days. • Suspicion of pleural blood contamination – defined as penetrating thoracoabdominal injury with suspected diaphragmatic injury and clinical or radiographic signs of concomitant hollow viscus injury (e.g. peritonism, haematemesis, or subdiaphragmatic free air). • Known malignant mesothelioma. • Enrolment in another interventional study likely to influence coagulation outcomes.	80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s)	18 Year(s)	99 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

No

22/06/2026

University of Witwatersrand HREC

Ethics Committee Address
Street address	City	Postal code	Country
3rd Floor, Phillip Tobias Building, Princes of Wales Terrace, Parktown	Johannesburg	2193	South Africa

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	Within-subject changes in R time, as measured by TEG viscoelastic assay	Before auto-transfusion, and 30 minutes plus or minus 10 minutes following completion of auto-transfusion
Secondary Outcome	• Within-subject changes in other TEG parameters (K time, α angle, maximum amplitude [MA], LY30) between T0 and T1. • Within-subject changes in PlateletMapping parameters (MA-ADP, MA-AA, MA-fibrin, percentage inhibition ADP, percentage inhibition AA) between T0 and T1. • Within-subject changes in venous blood gas parameters (haemoglobin, pH, ionised calcium, and lactate) between T0 and T1.	Before auto-transfusion, and 30 minutes plus or minus 10 minutes following completion of auto-transfusion
Secondary Outcome	In-hospital mortality, the documented incidence of sepsis, disseminated intravascular coagulation (DIC), acute respiratory distress syndrome (ARDS), and acute kidney injury (AKI).	At death or hospital discharge.

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Chris Hani Baragwanath Academic Hospital	26 Chris Hani Road, Diepkloof	Johannesburg	1864	South Africa

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Chris Hani Baragwanath Academic Hospital	26 Chris Hani Road, Diepkloof	Johannesburg	1864	South Africa

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Secondary Sponsor	Haemonetics Corporation are providing in kind device support by lending us the TEG6S analyser and providing cartridges for use	19 Lanner Falcon Road, Samrand, Centurion	Johannesburg	0187	South Africa	Commercial Sector/Industry

COLLABORATORS
Name	Street address	City	Postal code	Country

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Nicholas Chapman	nicholaschapman.nz@gmail.com	+61416593323	54A Kent Street, Richmond
City	Postal code	Country	Position/Affiliation
Melbourne	3121	Australia	Trauma Registrar at Chris Hani Baragwanath Academic Hospital
Role	Name	Email	Phone	Street address
Scientific Enquiries	Devorah Wineberg	baratraumaunit@gmail.com	+27724584876	26 Chris Hani Road, Diepkloof
City	Postal code	Country	Position/Affiliation
Johannesburg	1864	South Africa	Deputy Head of Trauma Unit and Trauma Surgeon at Chris Hani Baragwanath Academic Hospital
Role	Name	Email	Phone	Street address
Public Enquiries	Nicholas Chapman	nicholaschapman.nz@gmail.com	+61416593323	54A Kent Street, Richmond
City	Postal code	Country	Position/Affiliation
Melbourne	3121	Australia	Trauma Registrar at Chris Hani Baragwanath Academic Hospital

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	De-identified individual participant data collected during the trial, together with the study protocol and statistical analysis plan, are available from the principal investigator/s upon reasonable request, subject to institutional approval. Researchers wishing to access the HATCH dataset must apply through the Trauma Directorate (https://www.baragwanathtrauma.com).	Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol	Data will be available from 12 months after publication of the primary results paper for a period of 5 years.	Access will be granted to researchers who submit a written research proposal, provide institutional ethics approval for their proposed analysis, and sign a data-sharing agreement. Requests will be reviewed by the principal investigators, with re-identification risk assessed given the small sample size.
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
https://www.baragwanathtrauma.com/research	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information

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